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9. Research Grants


NHLBI Research Grants by Funding Mechanism: Fiscal Year 2010

Research Project Grants (RPGs)

Number of
Grants

Total Cost
(Dollars in Thousands)

Percent of
Total NHLBI
Research
Grant Dollars

Research Project Grants (Excluding Small Business RPGs)

 

 

 

Regular Research Grants (R01)

3,086

$1,382,729

59.85%

Program Project Grants (P01)

146

306,980

13.29

Cooperative Agreements (U01)

210

213,376

9.24

Explorative Developmental Grant (R21)

256

55,032

2.38

Method to Extend Research in Time (R37)

73

31,681

1.37

Exploratory/Developmental Grants Phase II (R33)

15

5,695

0.25

Clinical Trial Planning Grant (R34)

2

1,500

0.06

Clinical Planning Grant Cooperative Agreement (U34)

2

1,630

0.07

Academic Research Enhancement Award (R15)

11

2,960

0.13

NIH Director's Pioneer Award (DP1)

3

2,790

0.12

NIH Director's New Innovator's Award (DP2)

4

9,363

0.41

Research Transition Award (R00)

51

12,662

0.55

Cooperative Agreements (U19)

3

6,148

0.27

Linked Research Grant (RL1)

59

Subtotal, Research Project Grants (Excluding Small Business RPGs)

3,862

2,032,605

88.0

Small Business Research Project Grants

 

 

 

Small Business Technology Transfer (STTR Phase I) (R41)

11

2,836

0.12

Small Business Technology Transfer (STTR Phase II) (R42)

12

5,570

0.24

Small Business Innovation Research (SBIR Phase I) (R43)

64

12,578

0.54

Small Business Innovation Research (SBIR Phase II) (R44)

78

54,935

2.38

Subtotal, Small Business Research Project Grants

165

75,919

3.28

Subtotal, Research Project Grants

4,027

2,108,524

91.28

Research Centers Grants

 

 

 

Centers of Research Programs (P50)

22

57,278

2.48

Sickle Cell Centers (U54)

4

2,300

0.10

Centers for AIDS Research (P30)

3,368

0.15

Specialized Centers (Cooperative Agreements) (U54)

400

0.02

National Swine Research and Resource Center (U42)

555

0.02

Exploratory Grants (P20)

12

8,665

0.38

Subtotal, Research Centers Grants

38

72,566

3.14

Research Career Programs

 

 

 

Mentored Research Development Award for Minority Faculty (K01)

6

804

0.03

Minority Institution Faculty Mentored Research Scientist Award (K01)

47

6,089

0.26

Mentored Scientist Development Award in Research Ethics (K01)

61

Independent Scientist Award (K02)

19

1,847

0.08

Pediatric Transfusion Medicine Academic Award (K07)

4

486

0.02

Cultural Competence and Health Disparities Academic Award (K07)

4

562

0.02

Clinical Investigator Scientist Award (K08)

218

28,165

1.22

Clinical Hematology Research Career Development Program (K12)

6

2,371

0.10

Genetics and Genomics of Lung Disease Career Development Program (K12)

8

3,194

0.14

Career Enhancement Award for Stem Cell Research (K18)

4

706

0.03

Career Transition Award (K22)

1

162

0.01

Mentored Patient-Oriented Research Career Development Award (K23)

160

22,368

0.97

Midcareer Investigator Award in Patient-Oriented Research (K24)

35

5,942

0.26

Mentored Quantitative Research Career Development Award (K25)

15

2,135

0.09

Career Transition Award (K99)

64

6,652

0.29

Subtotal, Research Career Programs

591

81,544

3.53

Other Research Grants

 

 

 

Cooperative Clinical Research (U10, R10)

11

19,150

0.83

Minority Biomedical Research Support (S06, SC1, SC2)

11

2,540

0.11

Other (R13, R18, R24, R25, T15, U24, UH1)

120

26,011

1.13

Subtotal, Other Research Grants

142

47,701

2.06

Total, NHLBI Research Grants

4,798

$2,310,335

100%

NHLBI Total Research Grants by Category

NHLBI Total Research Grants by Category
Text-only with data points

NHLBI Research Project Grant,* Research Centers Grant, and Other Research Grant Obligations: Fiscal Years 2000–2010

NHLBI Research Project Grant,* Research Centers Grant, and Other Research Grant Obligations
Text-only with data points are represented in the table below.

* Includes R01, U01, P01, R03, R15, R21, R29, R37, R41, R42, R43, and R44; R33 beginning in 2001; DP2 and U19 beginning in 2007; DP1 and R00 beginning in 2008; and R34 and U34 beginning in 2010.
** Includes Research Career Programs; excludes General Research Support Grants.

NHLBI Research Project Grants,* Research Centers Grants, and Other Research Grant Obligations: Fiscal Years 2000–2010

Dollars (Thousands)

 

FY 2000

FY 2001

FY 2002

FY 2003

FY 2004

FY 2005

FY 2006

FY 2007

FY 2008

FY 2009

FY 2010

Research Project Grants*

$1,356,034

$1,580,751

$1,779,573

$1,920,201

$2,003,769

$2,042,050

$2,011,049

$1,986,692

$1,983,633

$2,039,861

$2,108,524

Research Centers Grants

123,803

127,232

128,161

138,941

140,600

151,495

141,086

141,034

107,393

90,152

72,566

Other Research Grants**

90,666

88,958

98,460

113,172

112,785

116,713

123,802

135,284

125,942

131,001

129,245

Total

$1,570,503

$1,796,941

$2,006,194

$2,172,314

$2,257,154

$2,310,258

$2,275,937

$2,263,010

$2,216,968

$2,261,014

$2,310,335

*Includes R01, U01, P01, R03, R15, R21, R29, R37, R41, R42, R43, and R44; R33 beginning in 2001; DP2 and U19 beginning in 2007; DP1 and R00 beginning in 2008; and R34 and U34 beginning in 2010.
** Includes Research Career Programs; excludes General Research Support Grants.

NHLBI Competing Research Project Grant Applications:* Fiscal Years 2000–2010

Number Reviewed and Awarded

NHLBI Competing Research Project Grant Applications*:  Fiscal Years 1998-2008
Text-only with data points are represented in the table below.

Number Reviewed and Awarded and Percent Funded

 

FY 2000

FY 2001

FY 2002

FY 2003

FY 2004

FY 2005

FY 2006

FY 2007

FY 2008

FY 2009

FY 2010

Applications Reviewed

2,893

2,895

3,064

3,098

3,548

3,865

4,412

4,504

4,492

4,373

4,528

RPGs Awarded

1,003

1,033

1,018

1,064

1,034

909

871

943

997

968

903

Success Rate (percent)

34.7

35.7

33.2

34.3

29.1

23.5

19.7

20.9

22.2

22.1

19.9

*  Includes R01, U01, P01, R03, R15, R21, R29, and R37; R33 beginning in 2001; DP2 and U19 beginning in 2007; DP1 and R00 beginning in 2008; and R34 and U34 beginning in 2010.

Percent of Reviewed Applications Funded (Success Rate)

NHLBI Competing Research Project Grant Applications*:  Fiscal Years 1998-2008
Text-only with data points are represented in the table above.

NHLBI Investigator-Initiated and Institute-Initiated Grant Obligations: Fiscal Years 2000–2010

NHLBI Investigator-Initiated and Institute-Initiated Grant Obligations:  Fiscal Years 1998-2008
Text-only with data points are represented in the table below.

* Includes RPGs, SBIRs/STTRs, Research Career Programs, and Other Research.
** Includes RPGs, Centers Grants, Research

NHLBI Investigator-Initiated and Institute-Initiated Grant Obligations: Fiscal Years 2000–2010

Dollars (Millions)

 

FY 2000

FY 2001

FY 2002

FY 2003

FY 2004

FY 2005

FY 2006

FY 2007

FY 2008

FY 2009

FY 2010

Investigator-Initiated*

$1,241.6

$1,446.2

$1,584.9

$1,681.9

$1,773.4

$1,822.9

$1,802.1

$1,774.8

$1,820.8

$1,850.1

$1,950.9

Institute-Initiated**

328.9

350.7

421.3

490.4

483.8

487.3

473.8

488.2

396.1

410.9

359.5

Total

$1,570.5

$1,796.9

$2,006.2

$2,172.3

$2,257.2

$2,310.2

$2,275.9

$2,263.0

$2,216.9

$2,261.0

$2,310.4

* Includes RPGs, SBIRs/STTRs, Research Career Programs, and Other Research.
** Includes RPGs, Centers Grants, Research Career Programs, Other Research, and Cooperative Agreement RFAs.

NHLBI Research Project Grants:*  Amount Funded by Type of Award, Fiscal Years 2000–2010

Dollars (Millions)

 

FY 2000

FY 2001

FY 2002

FY 2003

FY 2004

FY 2005

FY 2006

FY 2007

FY 2008

FY 2009

FY 2010

Competing

 

 

 

 

 

 

 

 

 

 

 

  New Competing

$   266.4

$   280.0

$   291.2

$   285.5

$   290.5

$   270.0

$   242.9

$   330.9

$   314.2

$ 340.2

$ 330.5

  Renewal Competing

152

143.9

143.9

177.2

185.5

176.1

168.3

169.4

196.9

172.6

171.6

  Competing
  Supplements

0.9

0.4

2.3

1

1.3

1.7

0.4

1.7

0.3

0.3

Subtotal, Competing

419.3

424.3

437.4

463.7

477.3

447.8

411.6

500.3

512.8

513.1

501.8

Noncompeting

 

 

 

 

 

 

 

 

 

 

 

Subtotal, Noncompeting

889.3

1,101.5

1,281.3

1,390.3

1,454.9

1,520.0

1,527.0

1,486.4

1,470.8

1,526.8

1,606.7

Total, Competing and Noncompeting

$1,308.6

$1,525.8

$1,718.7

$1,854.0

$1,932.2

$1,967.8

$1,938.6

$1,986.7

$1,983.6

$2,039.9

$2,108.5

* Includes R01, U01, P01, R03, R15, R21, R29, R37, R41, R42, R43, and R44; R33 beginning in 2001; DP2 and U19 beginning in 2007; DP1 and R00 beginning in 2008; and R34

Facility and Administrative (F&A) Costs of NHLBI Research Project Grants:* Fiscal Years 2000–2010

Dollars (Thousands)

Fiscal Year

Direct Cost

F&A Cost

Total Cost

F&A Cost as a
Percent of Direct Cost

2000

891,244

417,312

1,308,556

46.8

2001

1,045,144

480,673

1,525,817

46.0

2002

1,182,408

536,324

1,718,732

45.4

2003

1,276,819

577,131

1,853,950

45.2

2004

1,329,106

603,133

1,932,239

45.4

2005

1,355,803

612,007

1,967,810

45.1

2006

1,334,406

604,183

1,938,589

45.3

2007

1,378,134

608,558

1,986,692

44.2

2008

1,376,276

607,357

1,983,633

44.1

2009

1,410,033

629,828

2,039,861

44.7

2010

1,459,211

649,313

2,108,524

44.5

* Includes R01, U01, P01, R03, R15, R21, R29, R37, R41, R42, R43, and R44; R33 beginning in 2001; DP2 and U19 beginning in 2007; DP1 and R00 beginning in 2008; and R34 and U34 beginning in 2010.

NHLBI Research Project Grants:*  Average Costs, Fiscal Years 2000–2010

NHLBI Research Project Grants*:  Average Costs, Fiscal Years 1998-2008
Text-only with data points are represented in the table below.

* Includes R01, U01, P01, R03, R15, R21, R29, R37, R41, R42, R43, and R44; R33 beginning in 2001; DP2 and U19 beginning in 2007; DP1 and R00 beginning in 2008; and R34 and U34 beginning in 2010.

NHLBI Research Project Grants:*  Average Costs, Fiscal Years 2000–2010

Dollars (Thousands)

 

FY 2000

FY 2001

FY 2002

FY 2003

FY 2004

FY 2005

FY 2006

FY 2007

FY 2008

FY 2009

FY 2010

Noncompeting

$346.6

$390.7

$418.8

$444.4

$458.7

$490.6

$503.9

$510.3

$512.4

$509.8

$532.2

Competing

418.0

410.8

409.1

406.7

419.7

459.9

458.1

477.8

462.0

478.2

497.9

Total

$366.6

$396.1

$416.2

$433.8

$447.9

$484.8

$492.8

$501.7

$501.8

$501.4

$523.6

* Includes R01, U01, P01, R03, R15, R21, R29, R37, R41, R42, R43, and R44; R33 beginning in 2001; DP2 and U19 beginning in 2007; DP1 and R00 beginning in 2008; and R34 and U34 beginning in 2010.

NHLBI Cooperative Agreements (U01, U10, U19) Programs

Cooperative Agreements were instituted to support discrete, circumscribed projects in areas of an investigator's specific interest and competency with substantial programmatic participation by the NHLBI during performance of the activity.

 

Total Obligations Prior to FY 2010

Total FY 2010 Obligations

Total Obligations to Date

Heart and Vascular Diseases

 

 

 

AIM HIGH: Niacin Plus Statin To Prevent Vascular Events

$  15,518,128

$  5,568,478

$  21,086,606

ARIC Neurocognitive Study (ARIC-NCS)

4,024,211

4,024,211

Cardiovascular Cell Therapy Research Network

18,219,368

6,199,959

24,419,327

Cardiovascular Health Study (CHS) Events Follow-Up Study

5,857,326

1,247,777

7,105,103

Cardiovascular Outcomes in Renal Atherosclerotic Lesions (CORAL)

21,413,274

4,413,950

25,827,224

Catheter Ablation Versus Antiarrythmic Drug Therapy for Atrial Fibrillation (CABANA) Trial

2,940,676

3,044,967

5,985,643

Center for Cardiovascular Outcomes Research

5,203,594

5,203,594

Childhood Obesity Prevention and Treatment Research (COPTR)

4,058,435

4,058,435

Claudication Exercise Versus Endoluminal Revascularization (CLEVER)

6,567,493

1,079,923

7,647,416

Clinical Research Consortium To Improve Resuscitation Outcomes

40,203,762

6,243,690

46,447,452

Community-Responsive Intervention To Reduce Cardiovascular Risk in American Indians and Alaska Natives

8,882,655

2,070,651

10,953,306

Diabetes Prevention Program Outcomes Study—Phase II

1,100,000

1,100,000

2,200,000

Dynamic Evaluation of Percutaneous Coronary Intervention

7,681,543

732,168

8,413,711

Early Adult Reduction of Weight Through LifestYle Intervention (EARLY) Trials*

4,656,109

5,863,594

10,519,703

Effectiveness Research on Smoking Cessation in Hospitalized Patients

3,321,649

3,321,649

Genetics of Coronary Artery Disease in Alaskan Natives (GOCADAN)

17,365,899

138,160

17,504,059

Heart Failure Clinical Research Network

29,194,950

262,170

29,457,120

Improved Measures of Diet and Physical Activity for the Genes and Environment Initiative

7,192,192

1,986,571

9,178,763

Look AHEAD: Action for Health in Diabetes

4,000,000

4,000,000

8,000,000

Network for Cardiothoracic Surgical Investigation in Cardiovascular Medicine

17,900,101

8,078,705

25,978,806

NHLBI Cardiac Development Consortium

1,113,042

7,126,599

8,239,641

NHLBI Pediatric Cardiac Genomics Consortium

1,370,839

3,772,602

5,143,441

NHLBI Pediatric Translational Consortium Administrative Coordinating Center

417,107

10,036,869

10,453,976

NHLBI Progenitor Cell Biology Consortium Research Hubs

22,721,547

24,066,547

46,788,094

Occluded Artery Trial (OAT)

21,223,324

1,032,987

22,256,311

Pediatric Heart Network

55,877,857

7,471,016

63,348,873

Pharmacogenetics Research Network

67,847,214

6,574,122

74,421,336

Practice-Based Opportunity for Weight Reduction (POWER) Trials

13,666,191

2,329,121

15,995,312

Ranolazine in Implantable Defibrillators (RAID) Trial

2,279,794

2,279,794

Rule Out Myocardial Infarction Using Computed Assisted Tomography (ROMICAT II)

2,111,994

2,307,194

4,419,188

Strong Heart Study

70,858,608

3,020,433

73,879,041

Surgical Treatment for Ischemic Heart Failure (STICH)

38,807,719

1,233,343

40,041,062

Therapeutic Hypothermia after Pediatric Cardiac Arrest (THAPCA) Trials

3,648,449

2,285,274

5,933,723

Translating Basic Behavior and Social Science Discoveries Into Interventions To Reduce Obesity

5,431,213

5,556,238

10,987,451

Subtotal, Heart and Vascular Diseases

513,788,580

147,730,791

661,519,371

Lung Diseases

 

 

 

Asthma Networks (AsthmaNet)

 8,300,000

15,500,000

23,800,000

Childhood Asthma Management Program–Continuation Study (CAMP–CS)/Phase III

5,188,779

2,065,318

7,254,097

COPD Clinical Research Network

43,180,386

3,150,000

46,330,386

Genetic Epidemiology of COPD

23,297,945

7,731,991

31,029,936

Infant Study of Inhaled Saline in Cystic Fibrosis (ISIS)

1,469,184

775,690

2,244,874

Microbiome of the Lung and Respiratory Tract in HIV-Infected and in HIV-Uninfected Controls

 5,390,250

5,352,755

10,743,005

Novel Therapies for Lung Diseases—Phase II

7,593,739

7,593,739

Pharmacogenetics of Asthma Treatment

27,005,538

1,992,800

28,998,338

Prematurity and Respiratory Outcomes Program (PROP)

1,597,280

1,597,280

Preterm Birth in Nulliparous Women: An Understudied Population at Great Risk

500,000

500,000

Randomized Controlled Study of Adenotonsillectomy for Childhood Sleep Apnea

8,501,620

1,674,567

10,176,187

Randomized Trial of Antenatal Late Preterm Steroids (ALPS)

2,133,947

2,133,947

Randomized Trial of Maternal Vitamin D Supplementation To Prevent Childhood Asthma

2,510,256

2,465,649

4,975,905

Sedation Management in Pediatric Patients With Acute Respiratory Failure

4,452,227

3,326,889

7,779,116

Study of Acid Reflux Therapy for Children With Asthma

3,345,010

762,974

4,107,984

Study of Asthma and Nasal Steroids (STAN)

724,724

724,812

1,449,536

Study of Soy Isoflavones in Asthma (SOYA)

774,607

697,247

1,471,854

Trial of Late Surfactant (TOLSURF) To Prevent Bronchopulmonary Dysplasia (BPD)

1,986,898

1,778,953

3,765,851

Subtotal, Lung Diseases

136,127,424

59,824,611

195,952,035

Blood Diseases and Resources

 

 

 

Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis (ATTRACT)**

4,178,531

2,094,006

6,272,537

Blood and Marrow Transplant Clinical Research Network

56,563,600

2,507,421

59,071,021

Stroke With Transfusions Changing to Hydroxyurea (SWiTCH)

17,852,750

1,778,230

19,630,980

Study of Low Molecular Weight Heparin as a Bridge Before or After Surgery or a Procedure (BRIDGE)

10,305,131

5,226,772

15,531,903

Transfusion Medicine/Hemostasis Clinical Research Network

50,450,201

6,589,859

57,040,060

Subtotal, Blood Diseases and Resources

139,350,213

18,196,288

157,546,501

Total, NHLBI Cooperative Agreements

$789,266,217

$225,751,690

$1,015,017,907

* Formerly known as Targeted Approaches to Weight Control for Young Adults.
** Formerly known as Pharmacomechanical Catheter-Directed Thrombolysis for Acute DVT (ATTRACT) Trial.
† Formerly known as Bridging Anticoagulation on Patients Requiring Temporary Interruption of Warfarin Therapy for an Elective Invasive Procedure or Surgery (BRIDGE) Trial.

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Heart and Vascular Diseases Program

AIM HIGH: Niacin Plus Statin To Prevent Vascular Events, Initiated in Fiscal Year 2005

The purpose of this multicenter clinical trial is to determine whether extended-release niacin plus sim­vastatin is superior to simvastatin alone, at comparable levels of in-treatment LDL cholesterol, for preventing or delaying a major CVD event over a 4-year median follow-up period in patients with atherogenic dyslipidemia. Niacin is used to raise HDL ("good") cholesterol and simvastatin is used to lower LDL ("bad") cholesterol.

Obligations

Funding History:
Fiscal Year 2010—$5,568,478
Fiscal Years 2005–2009—$15,518,128
Total Funding to Date—$21,086,606

Current Active Organizations and Grant Numbers

  1. University of Washington
    Seattle, Washington —HL-081616
  2. AXIO Research, LLC
    Seattle, Washington —HL-081649

ARIC Neurocognitive Study (ARIC-NCS), Initiated in Fiscal Year 2010

The purpose of this study is to determine whether mid-life vascular risk factors and markers of macrovascular and microvascular disease are predictive of dementia, mild cognitive impairment, and cognitive change in a large biracial prospective ARIC cohort.

Obligations

Funding History:
Fiscal Year 2010—$4,024,211
Total Funding to Date—$4,024,211
 

Current Active Organizations and Grant Numbers

  1. Johns Hopkins University
    Baltimore, Maryland —HL-096812
  2. University of North Carolina
    Chapel Hill, North Carolina —HL-096814
  3. University of North Carolina
    Chapel Hill, North Carolina —HL-096899
  4. University of Minnesota
    Minneapolis, Minnesota —HL-096902
  5. University of Mississippi Medical Center
    Jackson, Mississippi —HL-096917

Cardiovascular Cell Therapy Research Network, Initiated in Fiscal Year 2007

See Chapter 11. Clinical Trials.

Cardiovascular Heart Study (CHS) Events Follow-Up Study, Initiated in Fiscal Year 2006

The purpose of this project is to evaluate the incidence and determinants of CHD and health in 1,964 surviving participants aged 80 years and older. The incidence of CVD in the oldest participants will be related to demographic variables; measures of disability, physical functioning, and cognitive function; measures of subclinical disease; and traditional and novel clinical risk factors and their changes over time. Seventeen percent of the participants are from minority populations.

Obligations

Funding History:
Fiscal Year 2010—$1,247,777
Fiscal Years 2006–2009—$5,857,326
Total Funding to Date—$7,105,103

Current Active Organization and Grant Number

  1. University of Washington
    Seattle, Washington HL-080295

Cardiovascular Outcomes in Renal Atherosclerotic Lesions (CORAL), Initiated in Fiscal Year 2004

The purpose of this trial is to determine whether revascularization of a stenotic renal artery plus medical therapy is associated with improved clinical outcomes compared with medical therapy alone.

Obligations

Funding History:
Fiscal Year 2010—$4,413,950
Fiscal Years 2004–2009—$21,413,274
Total Funding to Date—$25,827,224

Current Active Organizations and Grant Numbers

  1. University of Toledo HealthSciences
    CampusToledo, Ohio —HL-071556
  2. University of Minnesota, Twin Cities
    Minneapolis, Minnesota —HL-072734
  3. University of Virginia
    Charlottesville, Virginia —HL-072735
  4. Mid-America Heart Institute of St. Luke Hospital
    Kansas City, Missouri —HL-072736
  5. Beth Israel Deaconess Medical Center
    Boston, Massachusetts —HL-072737

Catheter Ablation Versus Antiarrythmic Drug Therapy for Atrial Fibrillation (CABANA), Initiated in Fiscal Year 2009

The purpose of this trial is to determine whether percutaneous left atrial catheter ablation is superior to current pharmacologic therapy for eliminating atrial fibrillation.

Obligations

Funding History:
Fiscal Year 2010—$3,044,967
Fiscal Year 2009—$2,940,676
Total Funding to Date—$5,985,643

Current Active Organizations and Grant Numbers

  1. Mayo Clinic, College of Medicine
    Rochester, Minnesota —HL-089645
  2. Mayo Clinic, College of Medicine
    Rochester, Minnesota —HL-089709
  3. Duke University
    Durham, North Carolina —HL-089786
  4. Duke University
    Durham, North Carolina —HL-089907

Center for Cardiovascular Outcomes Research, Initiated in Fiscal Year 2010

The purpose of this program is to conduct cardiovascular outcomes and comparative effectiveness research—natural experiments, quasi-experimental research, and practice-based trials—that focuses on patient- and clinician-relevant outcomes of health care and the determinants of these outcomes. The goal is to directly inform public policy and clinical practice.

Obligations

Funding History:
Fiscal Year 2010—$5,203,594
Total Funding to Date—$5,203,594

Current Active Organizations and Grant Numbers

  1. University of Massachusetts Medical School
    Worcester, Massachusetts —HL-105268
  2. Yale University
    New Haven, Connecticut —HL-105270
  3. Boston Medical Center
    Boston, Massachusetts —HL-105342
  4. Duke University
    Durham, North Carolina —HL-107023

Childhood Obesity Prevention and Treatment Research (COPTR), Initiated in Fiscal Year 2010

See Chapter 11. Clinical Trials.

Claudication: Exercise Versus Endoluminal Revascularization, Initiated in Fiscal Year 2005

The purpose of this study is to test the hypothesis that a strategy of aortoiliac stenting and pharmacotherapy improves maximum walking duration better than a strategy of supervised rehabilitation, exercise, and pharmacotherapy for those with aortoiliac artery obstruction at 6 months. Other objectives are to compare the two treatment groups with a third group, usual care and pharmacotherapy, at 6 months, and to compare maximum walking duration change scores at 18 months, changes in free living daily activity levels, and patient-perceived quality of life among all three groups.

Obligations

Funding History:
Fiscal Year 2010—$1,079,923
Fiscal Years 2005–2009—$6,567,493
Total Funding to Date—$7,647,416

Current Active Organizations and Grant Numbers

  1. Rhode Island Hospital
    Providence, Rhode Island —HL-077221
  2. Beth Israel Deaconess Medical Center
    Boston, Massachusetts —HL-081656

Clinical Research Consortium To Improve Resuscitation Outcomes, Initiated in Fiscal Year 2004

See Chapter 11. Clinical Trials.

Community-Responsive Intervention To Reduce Cardiovascular Risk in American Indians and Alaska Natives, Initiated in Fiscal Year 2006

See Chapter 11. Clinical Trials.

Diabetes Prevention Program Outcomes Study—Phase II, Initiated in Fiscal Year 2009

See Chapter 11. Clinical Trials.

Dynamic Evaluation of Percutaneous Coronary Intervention, Initiated in Fiscal Year 1997

The purpose of this program, which complements prior NHLBI percutaneous transluminal coronary angioplasty (PTCA) registries and the New Approaches to Coronary Intervention Registry, is to evaluate patterns of device usage and the immediate and follow-up outcomes in patients who are undergoing percutaneous transluminal coronary revascularization. Results will provide guidance to the cardiology community in selecting appropriate therapies and designing clinical trials to evaluate competing devices. Twenty-four percent of the patients are from various racial and ethnic minority populations.

Obligations

Funding History:
Fiscal Year 2010—$732,168
Fiscal Years 1997–2009—$7,681,543
Total Funding to Date—$8,413,711

Current Active Organization and Grant Number

  1. University of Pittsburgh
    Pittsburgh, Pennsylvania —HL-033292

Early Adult Reduction of Weight Through LifestYle Intervention (EARLY) Trials,* Initiated in Fiscal Year 2009

See Chapter 11. Clinical Trials.

* Formerly known as Targeted Approaches to Weight Control for Young Adults.

Effectiveness Research on Smoking Cessation in Hospitalized Patients, Initiated in Fiscal Year 2010

See Chapter 11. Clinical Trials.

Genetics of Coronary Artery Disease in Alaska Natives (GOCADAN), Initiated in Fiscal Year 2000

The purpose of this study is to document CVD and CVD risk factors in approximately 40 extended families (1,214 members from villages in Northern Alaska). Scientists seek to identify and characterize genes that contribute to CVD in this unique and understudied population.

Obligations

Funding History:
Fiscal Year 2010—$138,160
Fiscal Years 2000–2009—$17,365,899
Total Funding to Date—$17,504,059

Current Active Organization and Grant Number

  1. MedStar Research Institute
    Hyattsville, Maryland —HL-064244

Heart Failure Clinical Research Network, Initiated in Fiscal Year 2006

See Chapter 11. Clinical Trials.

Improved Measures of Diet and Physical Activity for the Genes and Environment Initiative, Initiated in Fiscal Year 2007

The purpose of this program is to support the development of devices to improve diet and physical activity. The program is part of the Genes and Environment Initiative, a 4-year NIH-wide program designed to lay the foundation for understanding the complex interplay between genetic and environmental factors in human diseases.

Obligations

Funding History:
Fiscal Year 2010—$1,986,571
Fiscal Years 2007–2009—$7,192,192
Total Funding to Date—$9,178,763

Current Active Organizations and Grant Numbers

  1. University of Pittsburgh
    Pittsburgh, Pennsylvania —HL-091736
  2. Massachusetts Institute of Technology
    Cambridge, Massachusetts —HL-091737
  3. Princeton Multimedia Technologies Corporation
    Princeton, New Jersey —HL-091738

Look AHEAD: Action for Health in Diabetes, Initiated in Fiscal Year 2009

See Chapter 11. Clinical Trials.

Network for Cardiothoracic Surgical Investigation in Cardiovascular Medicine, Initiated in Fiscal Year 2007

See Chapter 11. Clinical Trials.

NHLBI Cardiac Development Consortium, Initiated in Fiscal Year 2009

The purpose of this study is to gain complete understanding of the regulatory networks controlling cardiovascular development. A consortium of multidisciplinary research teams will select key regulatory pathways, identify components of the pathways and targets, and rapidly disseminate data to the scientific community. Research results may lead to the development of regenerative therapies and tissue engineering approaches.

Obligations

Funding History:
Fiscal Year 2010—$7,126,599
Fiscal Year 2009—$1,113,042
Total Funding to Date—$8,239,641

Current Active Organizations and Grant Numbers

  1. University of Utah
    Salt Lake City, Utah —HL-098160
  2. Harvard University Medical School
    Boston, Massachusetts —HL-098166
  3. J. David Gladstone Institutes
    San Francisco, California —HL-098179
  4. University of Pittsburgh
    Pittsburgh, Pennsylvania —HL-098180

NHLBI Pediatric Cardiac Genomics Consortium, Initiated in Fiscal Year 2009

The purpose of this study is to conduct clinical and translational research on the genetic causes of congenital heart disease and genetic contributions to outcome in individuals with congenital heart disease.

Obligations

Funding History:
Fiscal Year 2010—$3,772,602
Fiscal Year 2009—$1,370,839
Total Funding to Date—$5,143,441

Current Active Organizations and Grant Numbers

  1. Mount Sinai School of Medicine
    New York, New York —HL-098123
  2. Children's Hospital Boston
    Boston, Massachusetts —HL-098147
  3. Children's Hospital of Philadelphia
    Philadelphia, Pennsylvania —HL-098153
  4. Yale University
    New Haven, Connecticut —HL-098162
  5. Columbia University Health Sciences
    New York, New York —HL-098163

NHLBI Pediatric Translational Consortium Administrative Coordinating Center, Initiated in Fiscal Year 2009

The purpose of this Coordinating Center is to provide administrative support for the Cardiovascular Development Consortium and the Pediatric Cardiac Genomics Consortium, monitor multicenter patient recruitment by the Pediatric Cardiac Genomics Consortium, and administer funds to consortium-wide Cores.

Obligations

Funding History:
Fiscal Year 2010—$10,036,869
Fiscal Year 2009—$417,107
Total Funding to Date—$10,453,976

Current Active Organization and Grant Number

  1. New England Research Institute, Inc.
    Watertown, Massachusetts —HL-98188

NHLBI Progenitor Cell Biology Consortium Research Hubs, Initiated in Fiscal Year 2009

The purpose of this study is to establish virtual research hubs that focus on progenitor cell biology. Investigators will seek to identify and characterize progenitor cell lineages, direct the differentiation of stem and progenitor cells to desired cell fates, and develop new strategies to address the unique challenges presented by the transplantation of these cells.

Obligations

Funding History:
Fiscal Year 2010—$24,066,547
Fiscal Year 2009—$22,721,547
Total Funding to Date—$46,788,094

Current Active Organizations and Grant Numbers

  1. Children's Hospital of Philadelphia
    Philadelphia, Pennsylvania —HL-099656
  2. University of Wisconsin, Madison
    Madison, Wisconsin —HL-099773
  3. Johns Hopkins University
    Baltimore, Maryland —HL-099775
  4. Stanford University
    Stanford, California —HL-099776
  5. Fred Hutchinson Cancer Research Center
    Seattle, Washington —HL-099993
  6. Stanford University
    Stanford, California —HL-099995
  7. University of Maryland
    Baltimore, Maryland —HL-099997
  8. Stanford University
    Stanford, California —HL-099999
  9. Children's Hospital Boston
    Boston, Massachusetts —HL-100001
  10. Fred Hutchinson Cancer Research Center
    Seattle, Washington —HL-100395
  11. Stanford University
    Stanford, California —HL-100397
  12. Vanderbilt University
    Nashville, Tennessee —HL-100398
  13. University of Texas Southwestern
    Medical Center
    Dallas, Texas —HL-100401
  14. Massachusetts General Hospital
    Boston, Massachusetts —HL-100402
  15. University of Pennsylvania
    Philadelphia, Pennsylvania —HL-100405
  16. J. David Gladstone Institutes
    San Francisco, California —HL-100406
  17. University of Minnesota, Twin Cities
    Minneapolis, Minnesota —HL-100407
  18. Massachusetts General Hospital
    Boston, Massachusetts —HL-100408

Occluded Artery Trial (OAT), Initiated in Fiscal Year 1999

The purpose of this study is to determine whether percutaneous revascularization to open an occluded artery within a few days or as long as a month fol­lowing an acute MI in asymptomatic patients improves their outcome. Although the benefits of early restoration of blood flow following an acute MI have been well-established, it is not known whether later intervention is also beneficial. The trial is in a long-term follow-up phase.

Obligations

Funding History:
Fiscal Year 2010—$1,032,987
Fiscal Years 1999–2009—$21,223,324
Total Funding to Date—$22,256,311

Current Active Organizations and Grant Numbers

  1. New York University School of Medicine
    New York, New York —HL-062509
  2. Clinical Trials and Surveys Corporation
    Owings Mills, Maryland —HL-062511

Pediatric Heart Network, Initiated in Fiscal Year 2006

See Chapter 11. Clinical Trials.

Pharmacogenetics Research Network, Initiated in Fiscal Year 2001

The purpose of this study is to establish a network to systematically evaluate candidate genes that may influence pharmacologic response to drug treatments for arrhythmia, heart failure, hypertension, and lipid disorders. Investigators seek to identify gene polymorphisms capable of predicting drug toxicity and efficacy. One of the projects has 38 percent minority participation.

Obligations

Funding History:
Fiscal Year 2010—$6,574,122
Fiscal Years 2001–2009—$67,847,214
Total Funding to Date—$74,421,336

Current Active Organizations and Grant Numbers

  1. Vanderbilt University
    Nashville, Tennessee —HL-065962
  2. Children's Hospital and Research Center
    Oakland, California —HL-069757
  3. University of Maryland
    Baltimore, Maryland —HL-105198

Practice-Based Opportunity for Weight Reduction (POWER) Trials,* Initiated in Fiscal Year 2006

See Chapter 11. Clinical Trials.

* Formerly known as Weight-Loss in Obese Adults With Cardiovascular Risk Factors.

Ranolazine in Implantable Defibrillators (RAID) Trial, Initiated in Fiscal Year 2010

The purpose of this clinical trial is to determine whether ranolazine will reduce the risk of ventricular arrhythmias and improve survival in high-risk patients who already have an implantable cardiac defibrillator. Currently, very few options are available for treating patients at risk for ventricular arrhythmias—which often leads to death—and ranolazine may be a safe and effective treatment.

Funding History:
Fiscal Year 2010—$2,279,794
Total Funding to Date—$2,279,794

Current Active Organizations and Grant Numbers

  1. University of Rochester
    Rochester, New York —HL-096607
  2. University of Rochester
    Rochester, New York —HL-096610

Rule Out Myocardial Infarction Using Computed Assisted Tomography (ROMICAT II), Initiated in Fiscal Year 2009

The purpose of this study is to determine whether using cardiac computed assisted tomography early in the emergency department triage process will enable immediate and safe discharge without further testing of a significant number of patients with acute chest pain.

Obligations

Funding History:
Fiscal Year 2010—$2,307,194
Fiscal Year 2009—$2,111,994
Total Funding to Date—$4,419,188

Current Active Organizations and Grant Numbers

  1. Massachusetts General Hospital
    Boston, Massachusetts —HL-092022
  2. Massachusetts General Hospital
    Boston, Massachusetts —HL-092040

Strong Heart Study, Initiated in Fiscal Year 1988

The objectives of this study are to survey CVD morbidity and mortality rates among three geographically diverse groups of American Indians and to estimate their levels of CVD risk factors. Phases II and III of the cohort study extended surveillance of community mortality and assessed development of CVD and changes in CVD risk factors. In Phase III, investigators added a substudy of asthma and a pilot family study. Phase IV expanded the family study to 120 families comprising 3,600 members to investigate genetic and environmental contributors of CVD. Phase V examined the family study cohort to assess genetic relationships to risk factor change over a 5‑year period and initiated surveillance for cardiovascular morbidity and mortality.

Obligations

Funding History:
Fiscal Year 2010—$3,020,433
Fiscal Years 1988–2009—$70,858,608
Total Funding to Date—$73,879,041

Current Active Organizations and Grant Numbers

  1. MedStar Research Institute
    Hyattsville, Maryland —HL-041642
  2. Missouri Breaks Research, Inc.
    Timberlake, South Dakota —HL-041652
  3. University of Oklahoma
    Oklahoma City, Oklahoma —HL-041654
  4. Weill Medical College
    New York, New York —HL-065521

Surgical Treatment for Ischemic Heart Failure (STICH), Initiated in Fiscal Year 2002

The objectives of this clinical trial are to determine whether (a) the addition of CABG to intensive medical therapy improves long-term survival of patients with heart failure and left ventricular (LV) dysfunction who have coronary artery disease amenable to surgical revascularization or (b) CABG plus surgical ventricular reconstruction to a more normal LV size improves survival free of subsequent hospitalizations of patients with anterior LV dysfunction, compared with CABG alone. Investigators found that CABG plus ventricular reconstruction offers no benefit over CABG alone.

Obligations

Funding History:
Fiscal Year 2010—$1,233,343
Fiscal Years 2002–2009—$38,807,719
Total Funding to Date—$40,041,062

Current Active Organizations and Grant Numbers

  1. Duke University
    Durham, North Carolina —HL-069013
  2. Duke University
    Durham, North Carolina —HL-069015

Therapeutic Hypothermia After Pediatric Cardiac Arrest (THAPCA) Trials, Initiated in Fiscal Year 2009

The purpose of this program is to determine whether therapeutic hypothermia after pediatric cardiac arrest improves outcomes, including survival, in infants and children. Approximately 50 percent of the patients are expected to come from racial and ethnic minority populations.

Obligations

Funding History:
Fiscal Year 2010—$2,285,274
Fiscal Year 2009—$3,648,449
Total Funding to Date—$5,933,723

Current Active Organizations and Grant Numbers

  1. University of Utah
    Salt Lake City, Utah —HL-094339
  2. University of Michigan at Ann Arbor
    Ann Arbor, Michigan —HL-094345

Translating Basic Behavioral and Social Science Discoveries Into Interventions To Reduce Obesity, Initiated in Fiscal Year 2009

The purpose of this study is to develop innovative obesity-reducing strategies that should be effective in small-scale trials, acceptable to target populations of interest, and ready to be tested in large-scale randomized clinical and community trials. Some of the projects are expected to have 50–100 percent participation from minority populations.

Obligations

Funding History:
Fiscal Year 2010—$5,556,238
Fiscal Year 2009—$5,431,213
Total Funding to Date—$10,987,451

Current Active Organizations and Grant Numbers

  1. Claremont Graduate University
    Claremont, California —HL-097839
  2. Weill Medical College of Cornell University
    New York, New York —HL-097843
  3. Wayne State University
    Detroit, Michigan —HL-097889
  4. Rush University Medical Center
    Chicago, Illinois —HL-097894
  5. University of California, San Francisco
    San Francisco, California —HL-097973

Lung Diseases Program

Asthma Networks (AsthmaNet)

See Chapter 11. Clinical Trials.

Childhood Asthma Management Program–Continuation Study (CAMP–CS)/Phase III, Initiated in Fiscal Year 2007

The objective of this observational study is to follow the original CAMP cohort for 4 more years (through ages 21–29) to determine clinical and genetic risk factors for patterns of lung function decline indicative of chronic air flow obstruction in later adulthood; 31 percent of the participants are from minority groups.

Obligations

Funding History:
Fiscal Year 2010—$2,065,318
Fiscal Years 2007–2009—$5,188,779
Total Funding to Date—$7,254,097

Current Active Organizations and Grant Numbers

  1. Washington University
    St. Louis, Missouri —HL-075232
  2. Hospital for Sick Children
    Toronto, Ontario —HL-075407
  3. Johns Hopkins University
    Baltimore, Maryland —HL-075408
  4. Asthma, Inc.
    Seattle, Washington —HL-075409
  5. University of California, San Diego
    La Jolla, California —HL-075415
  6. National Jewish Medical and Research Center
    Denver, Colorado —HL-075416
  7. Johns Hopkins University
    Baltimore, Maryland —HL-075417
  8. Brigham and Women's Hospital
    Boston, Massachusetts —HL-075419
  9. University of New Mexico
    Albuquerque, New Mexico —HL-075420

COPD Clinical Research Network, Initiated in Fiscal Year 2003

See Chapter 11. Clinical Trials.

Genetic Epidemiology of COPD, Initiated in Fiscal Year 2007

The purpose of this study is to perform a genome-wide association analysis to identify the genetic risk factors that determine susceptibility for COPD and COPD-related phenotypes in a large biracial population. Investigators are using computer tomography and clinical and physiological measures to separate the broad COPD syndrome into clinically significant subtypes.

Obligations

Funding History:
Fiscal Year 2010—$7,731,991
Fiscal Years 2007–2009—$23,297,945
Total Funding to Date—$31,029,936

Current Active Organizations and Grant Numbers

  1. Brigham and Women's Hospital
    Boston, Massachusetts —HL-089856
  2. National Jewish Medical and Research Center
    Denver, Colorado —HL-089897

Infant Study of Inhaled Saline in Cystic Fibrosis (ISIS), Initiated in Fiscal Year 2008

The purpose of this randomized clinical trial is to assess the efficacy and safety of 7 percent hypertonic saline inhaled twice daily for 48 weeks among infants with CF aged 4 to 15 months at enrollment. Investigators are seeking to determine whether hypertonic saline will improve hyperinflation and obstructive lung disease as measured by infant lung function testing compared with the control agent (isotonic saline).

Obligations

Funding History:
Fiscal Year 2010—$775,690
Fiscal Years 2008–2009—$1,469,184
Total Funding to Date—$2,244,874

Current Active Organizations and Grant Numbers

  1. Children's Hospital and Regional Medical Center
    Seattle, Washington —HL-092931
  2. University of Washington
    Seattle, Washington —HL-092932

Microbiome of the Lung and Respiratory Tract in HIV-Infected Individuals and HIV-Uninfected Controls, Initiated in Fiscal Year 2009

The purpose of this study is to characterize the microbiome of the lung alone or in combination with the upper airways in HIV-infected individuals and matched HIV-uninfected controls. Investigators will use molecular techniques to identify bacteria, and if possible, other organisms (e.g., viruses, cell-wall deficient organisms, protozoa, and fungi). Data will be used to examine the effects of changes in the respiratory microbiome on the pathogenesis and progression of HIV disease, HIV-related respiratory complications, and anti-HIV therapies.

Obligations

Funding History:
Fiscal Year 2010—$5,352,755
Fiscal Year 2009—$5,390,250

Total Funding to Date—$10,743,005

Current Active Organizations and Grant Numbers

  1. University of Pennsylvania
    Philadelphia, Pennsylvania —HL-098957
  2. George Washington University
    Washington, DC —HL-098958
  3. Indiana University-Purdue University at Indianapolis
    Indianapolis, Indiana —HL-098960
  4. University of Michigan at Ann Arbor
    Ann Arbor, Michigan —HL-098961
  5. University of Pittsburgh
    Pittsburgh, Pennsylvania —HL-098962
  6. University of California, San Francisco
    San Francisco, California —HL-098964
  7. University of Colorado
    Denver, Colorado —HL-098966

Novel Therapies for Lung Diseases—Phase II, Initiated in Fiscal Year 2010

See Chapter 11. Clinical Trials.

Pharmacogenetics of Asthma Treatment, Initiated in Fiscal Year 2000

The objective of this project is to bring together research experts in asthma, epidemiology, statistics, bioinformatics, physiology, clinical trials, genetics, and genomics to focus on the pharmacogenetics of asthma treatment.

Obligations

Funding History:
Fiscal Year 2010—$1,992,800
Fiscal Years 2000–2009— $27,005,538
Total Funding to Date—$28,998,338

Current Active Organization and Grant Number

  1. Brigham and Women's Hospital
    Boston, Massachusetts —HL-065899

Prematurity and Respiratory Outcomes Program (PROP), Initiated in Fiscal Year 2010

The purpose of this observational clinical study is to investigate hypotheses on the molecular mechanisms that contribute to respiratory disease risk of the premature newborn with the long-term goal of improving outcomes in the first year of life.

Obligations

Funding History:
Fiscal Year 2010—$1,597,280
Total Funding to Date—$1,597,280

Current Active Organizations and Grant Numbers

  1. Vanderbilt University
    Nashville, Tennessee —HL-101456
  2. Washington University
    St. Louis, Missouri —HL-101465
  3. University of Pennsylvania
    Philadelphia, Pennsylvania —HL-101794
  4. University of California, San Francisco
    San Francisco, California —HL-101798
  5. Children's Hospital Medical Center, Cincinnati
    Cincinnati, Ohio —HL-101800
  6. University of Rochester
    Rochester, New York —HL-101813

Preterm Birth in Nulliparous Women: An Understudied Population at Great Risk, Initiated in Fiscal Year 2010

The purpose of this study is to create a network of clinical research sites with a Data Coordinating and Analysis Center to develop common research protocols to study nulliparous women (women in their first pregnancies) to prevent preterm birth and other related adverse pregnancy outcomes.

Obligations

Funding History:
Fiscal Year 2010—$500,000
Total Funding to Date—$500,000

Current Active Organization and Grant Number

  1. Research Triangle Institute
    Research Triangle, North Carolina —HD-063036

Randomized Controlled Study of Adenotonsillectomy for Childhood Sleep Apnea, Initiated in Fiscal Year 2006

The purpose of this randomized controlled study is to compare adenotonsillectomy and watchful waiting followed by reevaluation after 7 months for treatment of OSA in children aged 5 to 9 years; 75 percent of the participants are from various racial and ethnic minority populations.

Obligations

Funding History:
Fiscal Year 2010—$1,674,567
Fiscal Years 2006–2009—$8,501,620
Total Funding to Date—$10,176,187

Current Active Organizations and Grant Numbers

  1. Brigham and Women's Hospital
    Boston, Massachusetts —HL-083075
  2. University of Pennsylvania
    Philadelphia, Pennsylvania —HL-083129

Randomized Trial of Antenatal Late Preterm Steroids (ALPS), Initiated in Fiscal Year 2010

The purpose of this study is to determine whether antenatal corticosteroids can potentially improve lung function and reduce respiratory morbidity in newborn infants who are born in the late preterm period (34–36 weeks). Studies have proved that steroids improve lung function in very premature infants but have not been evaluated in infants likely to deliver in the late preterm period. Fifty-five percent of the participants are expected to come from racial and ethnic minority populations.

Obligations

Funding History:
Fiscal Year 2010—$2,133,947
Total Funding to Date—$2,133,947

Current Active Organizations and Grant Numbers

  1. George Washington University
    Washington, DC —HL-098354
  2. Columbia University Health Sciences
    New York, New York —HL-098554

Randomized Trial of Maternal Vitamin D Supplementation To Prevent Childhood Asthma, Initiated in Fiscal Year 2009

The purpose of this randomized clinical trial is to determine whether supplemental vitamin D to increase the level of vitamin D in a pregnant woman will prevent asthma and allergy in her child at age 3 years. Investigators will recruit 870 pregnant women who are in the first trimester of pregnancy. This sample will be randomized to one of two treatment arms of a 4-year clinical trial: 4,000 international units of vitamin D in addition to typical prenatal vitamins and typical prenatal vitamins alone. Currently, 70 percent of the participants are from racial and ethnic minority populations.

Obligations

Funding History:
Fiscal Year 2010—$2,465,649
Fiscal Year 2009—$2,510,267
Total Funding to Date—$4,975,905

Current Active Organizations and Grant Numbers

  1. Washington University
    St. Louis, Missouri —HL-091075
  2. Brigham and Women's Hospital
    Boston, Massachusetts —HL-091528

Sedation Management in Pediatric Patients With Acute Respiratory Failure, Initiated in Fiscal Year 2008

The purpose of this randomized clinical trial is to test an innovative approach to sedation management that includes team education and consensus on the use of sedatives in pediatric patients supported on mechanical ventilation; team identification of each patient's trajectory of illness and daily prescription of a sedation goal; use of a nurse-implemented goal-directed comfort algorithm that guides moment-to-moment titration of opioids and benzodiazepines; and team feedback on sedation management performance. Investigators will randomize 2,754 critically ill infants and children into two study groups: sedation management intervention and usual care. Forty-five percent of the patients are from racial and ethnic minority populations.

Obligations

Funding History:
Fiscal Year 2010—$3,326,889
Fiscal Years 2008–2009—$4,452,227
Total Funding to Date—$7,779,116

Current Active Organizations and Grant Numbers

  1. University of Pennsylvania
    Philadelphia, Pennsylvania —HL-086622
  2. Children's Hospital Boston
    Boston, Massachusetts —HL-086649

Study of Acid Reflux Therapy for Children With Asthma, Initiated in Fiscal Year 2006

The purpose of this randomized controlled clinical trial is to investigate whether an approved proton-pump inhibitor lansoprazole will reduce asthma exacerbations in children (aged 6–16 years) with poorly controlled asthma. Two-thirds of participants are from racial and ethnic minority populations.

Obligations

Funding History:
Fiscal Year 2010—$762,974
Fiscal Years 2006–2009—$3,345,010
Total Funding to Date—$4,107,984

Current Active Organizations and Grant Numbers

  1. University of Virginia
    Charlottesville, Virginia —HL-080433
  2. Johns Hopkins University
    Baltimore, Maryland —HL-080450

Study of Asthma and Nasal Steroids (STAN), Initiated in Fiscal Year 2009

The purpose of this clinical trial is to determine whether the addition of treatment of chronic rhinitis and sinusitis with a nasal steroid will improve asthma control. Investigators will randomize 380 patients with poorly controlled asthma and chronic rhinitis/sinusitis to a nasal steroid or matching placebo in addition to their regular asthma treatment. One third of participants are expected to be from minority populations.

Obligations

Funding History:
Fiscal Year 2010—$724,812
Fiscal Year 2009—$724,724
Total Funding to Date—$1,449,536

Current Active Organizations and Grant Numbers

  1. University of Vermont
    Burlington, Vermont —HL-089464
  2. Johns Hopkins University
    Baltimore, Maryland —HL-089510

Study of Soy Isoflavones in Asthma (SOYA), Initiated in Fiscal Year 2009

The purpose of this double-blind, randomized con­trolled trial is to assess the effectiveness of genistein supplements (soy isoflavone) in improving lung function in patients with poorly controlled asthma. The study will include 380 patients with low dietary soy intake, ages 12 years and older, who are taking inhaled corticosteroids, leukotriene modifiers, or both and have poorly controlled asthma. Participants will be randomly assigned to treatment with either a soy isoflavone supplement (containing genistein, daidzein, and glycitein) 100 mg daily or to placebo for 6 months. Thirty percent of participants are expected to be from minority populations.

Obligations

Funding History:
Fiscal Year 2010—$697,247
Fiscal Year 2009—$774,607
Total Funding to Date—$1,471,854

Current Active Organizations and Grant Numbers

  1. Northwestern University
    Evanston, Illinois —HL-087987
  2. Johns Hopkins University
    Baltimore, Maryland —HL-088367

Trial of Late Surfactant (TOLSURF) To Prevent Bronchopulmonary Dysplasia, Initiated in Fiscal Year 2009

The purpose of this randomized controlled clinical trial is to determine whether late doses of surfactant in addition to iNO administered to extremely low gestational age neonates (< 30 weeks) who require mechanical ventilation between 7 and 14 days of age will increase survival without bronchopulmonary dysplasia.

Obligations

Funding History:
Fiscal Year 2010—$1,778,953
Fiscal Year 2009—$1,986,898
Total Funding to Date—$3,765,851

Current Active Organizations and Grant Numbers

  1. University of California, San Francisco
    San Francisco, California —HL-094338
  2. University of California, San Francisco
    San Francisco, California —HL-094355

Blood Diseases and Resources

Acute Venous Thrombosis: Thrombus Removal With Adjunctive Catheter-Directed Thrombolysis (ATTRACT),* Initiated in Fiscal Year 2008

The purpose of this study is to determine whether adjunctive pharmacomechanical catheter-directed thrombolysis, which includes intrathrombus admin­­istration of recombinant tissue plasminogen activator, can prevent postthrombotic syndrome in patients with symptomatic proximal deep vein thrombosis (DVT) compared with optimal standard DVT therapy alone.

Obligations

Funding History:
Fiscal Year 2010—$2,094,006
Fiscal Years 2008–2009—$4,178,531
Total Funding to Date—$6,272,537

Current Active Organizations and Grant Numbers

  1. McMaster University
    Hamilton, Ontario —HL-088118
  2. Washington University
    St. Louis, Missouri —HL-088476

* Formerly known as Pharmacomechanical Catheter-Directed Thrombolysis for Acute DVT (ATTRACT) Trial.

Blood and Marrow Transplant Clinical Research Network, Initiated in Fiscal Year 2001

See Chapter 11. Clinical Trials.

Stroke With Transfusions Changing to Hydroxyurea (SWiTCH), Initiated in Fiscal Year 2005

The purpose of this Phase III clinical trial is to compare standard therapy (transfusions and chelation) with alternative therapy (hydroxyurea and phlebotomy) for the prevention of secondary stroke and management of iron overload in children with sickle cell anemia. Additional objectives include comparisons of growth and development, frequency of nonstroke neurological and other sickle-related events, and quality of life. All of the participants are black.

Obligations

Funding History:
Fiscal Year 2010—$1,778,230
Fiscal Years 2005–2009—$17,852,750
Total Funding to Date—$19,630,980

Current Active Organizations and Grant Numbers

  1. St. Jude Children's Research Hospital
    Memphis, Tennessee —HL-078787
  2. Rho Federal Systems Division, Inc.
    Chapel Hill, North Carolina —HL-078987

Study of Low Molecular Weight Heparin as a Bridge Before or After Surgery or a Procedure (BRIDGE)* Trial, Initiated in Fiscal Year 2008

The purpose of this study is to determine the safety and efficacy of low molecular weight heparin (LMWH) in adults with atrial fibrillation who stop warfarin in preparation for surgery. The trial will randomly allocate 3,282 patients with atrial fibrillation to either LMWH or matching placebo before and after surgery. Investigators hypothesize that simply withholding warfarin in a perioperative setting for patients with atrial fibrillation will not meaningfully increase the risk for arterial thromboembolism and will forestall hemorrhagic complications, compared with a strategy using LMWH before and after surgery. One-third of participants are expected to be from minority populations.

Obligations

Funding History:
Fiscal Year 2010—$5,226,772
Fiscal Year 2008–2009—$10,305,131
Total Funding to Date—$15,531,903

Current Active Organizations and Grant Numbers

  1. Duke University
    Durham, North Carolina —HL-086755
  2. Duke University
    Durham, North Carolina —HL-087229

* Formerly known as Bridging Anticoagulation on Patients Requiring Temporary Interruption of Warfarin Therapy for an Elective Invasive Procedure or Surgery (BRIDGE) Trial.

Transfusion Medicine/Hemostasis Clinical Research Network, Initiated in Fiscal Year 2002

See Chapter 11. Clinical Trials.

NHLBI Centers of Research Program (P50)

The Centers of Research Program supports specialized centers that focus on multidisciplinary research and development from basic science to clinical investigation in response to announcements of the programmatic needs of the Institute. The spectrum of activities comprises a multifaceted attack on a specific disease entity or biomedical problem area.

NHLBI Centers of Research Program

Type of Center Period of Operation Prior to
FY 2010
FY 2010 Total to Date

NIH Centers for Population and Health Disparities (CPHHD)

2010–

$9,898

$9,898

Subtotal, CPHHD

 

$9,898

$9,898

Specialized Centers of Clinically Oriented Research (P50)

 

 

 

 

Heart and Vascular Diseases Program

 

 

 

 

Vascular Injury, Repair, and Remodeling

2006–

57,170

12,473

69,643

Subtotal, Heart and Vascular Diseases Program

 

57,170

12,473

69,643

Lung Diseases Program

 

 

 

 

Chronic Obstructive Pulmonary Disease

2007–

33,464

11,317

44,781

Host Factors in Chronic Lung Diseases

2006–

32,338

8,673

41,011

Pulmonary Vascular Disease

2007–

19,212

6,346

25,558

Subtotal, Lung Diseases Program

 

85,014

26,336

111,350

Blood Diseases and Resources Program

 

 

 

 

Hemostatic and Thrombotic Diseases

2006–

32,554

8,570

41,124

Subtotal, Blood Diseases and Resources Program

 

32,554

8,570

41,124

Subtotal, SCCOR (P50)

 

$174,738

$47,379

$222,117

Total, Centers of Research Program (P50)

 

$174,738

$57,277

$232,015



NIH Centers for Population Health and Health Disparities (CPHHD) (P50)

The purpose of this program is to create centers of transdisciplinary research that will evaluate the multilevel determinants of health disparities and devise interventions to reduce them.

Obligations

Fiscal Year 2010—$9,898,210

Current Active Organizations and Grant Numbers

  1. Washington University
    St. Louis, Missouri —HL-105184
  2. Northeastern University
    Boston, Massachusetts —HL-105185
  3. Johns Hopkins University
    Baltimore, Maryland —HL-105187
  4. University of California, Los Angeles
    Los Angeles, California —HL-105188
  5. Rush University Medical Center
    Chicago, Illinois —HL-105189

Specialized Centers of Clinically Oriented Research (P50)

The NHLBI initiated the Specialized Centers of Research (SCOR) program in 1971 to encourage translational research—converting basic science findings to the clinic—in high priority areas. The SCOR concept emphasized multidisciplinary research (i.e., basic science and clinical investigations) on diseases relevant to the Institute's mission. In 2002, the NHLBI revised the SCOR program—primarily on recommendation from the NHLBAC—to place more emphasis on clinical research projects. The SCCOR program still requires clinical and basic scientists to work together on a unified theme, but now requires at least 50 percent of the projects to be clinical. The SCOR program ended in 2008.

A description of the SCCORs supported by the Institute follows.

Heart and Vascular Diseases Program

Vascular Injury, Repair, and Remodeling

The purpose of this SCCOR is to foster multidisciplinary research on clinically relevant questions that will enable basic science findings to be more rapidly translated into clinical applications. Major goals of the program are to stimulate interdependent clinical and multidisciplinary basic research projects that investigate molecular and cellular mechanisms of vascular injury, repair, and remodeling; promote patient-oriented research that will improve our ability to prevent, detect, characterize, manage, and treat vascular diseases; and develop the skills and research capabilities of new clinical investigators.

Obligations

Fiscal Year 2010—$12,472,870

Current Active Organizations and Grant Numbers

  1. Washington University
    St. Louis, Missouri —HL-083762
  2. University of Texas Health Science Center
    Houston, Texas —HL-083794
  3. University of Pennsylvania
    Philadelphia, Pennsylvania —HL-083799
  4. Stanford University
    Stanford, California —HL-083800
  5. Boston University Medical Campus
    Boston, Massachusetts —HL-083801

Lung Diseases Program

Chronic Obstructive Pulmonary Disease

The purpose of this SCCOR is to foster multidisciplinary research to accelerate progress in the diagnosis, prevention, and treatment of COPD. The program will include a broad spectrum of basic and clinical research that will encompass animal models of COPD pathogenesis, human proteomic, genetic and genomic investigations, technologically refined disease phenotypes classification, and the development of new experimental therapeutic interventions.

Obligations

Fiscal Year 2010—$11,317,450

Current Active Organizations and Grant Numbers

  1. Washington University
    St. Louis, Missouri —HL-084922
  2. Weill Medical College of Cornell University
    New York, New York —HL-084936
  3. Johns Hopkins University
    Baltimore, Maryland —HL-084945
  4. University of Pittsburgh
    Pittsburgh, Pennsylvania —HL-084948

Host Factors in Chronic Lung Diseases

The purpose of this SCCOR is to identify alterations in host responses and lung homeostasis and to determine how the dysregulation contributes to development or progression of chronic lung diseases. Enhanced understanding of these processes should facilitate identification of new targets for intervention, providing the basis for development of new therapeutic options for prevention and treatment of chronic lung diseases.

Obligations

Fiscal Year 2010—$8,673,261

Current Active Organizations and Grant Numbers

  1. Duke University
    Durham, North Carolina —HL-084917
  2. University of Pittsburgh
    Pittsburgh, Pennsylvania —HL-084932
  3. University of North Carolina
    Chapel Hill, North Carolina —HL-084934

Pulmonary Vascular Disease

The objective of this SCCOR is to facilitate multidisciplinary research that proposes original hypotheses and applies cutting-edge approaches, including genomics and proteomics, to clinical issues in pulmonary vascular disease.

Obligations

Fiscal Year 2010—$6,345,936

Current Active Organizations and Grant Numbers

  1. University of Colorado at Denver
    Denver, Colorado —HL-084923
  2. Johns Hopkins University
    Baltimore, Maryland —HL-084946

Blood Diseases and Resources Program

Hemostatic and Thrombotic Diseases

The purpose of this SCCOR is to conduct multidisciplinary research to improve the prevention, diagnosis, and treatment of thrombotic and bleeding disorders. The program will support rapid translation of basic science findings into clinical application.

Obligations

Fiscal Year 2010—$8,570,237

Current Active Organizations and Grant Numbers

  1. Vanderbilt University
    Nashville, Tennessee —HL-081009
  2. Cleveland Clinic Lerner College
    Cleveland, Ohio —HL-081011
  3. University of Pennsylvania
    Philadelphia, Pennsylvania —HL-081012

Basic and Translational Research Program (U54)

The NHLBI reconfigured the Comprehensive Sickle Cell Centers program into a Basic and Translational Research Program (BTRP). The Program emphasizes fundamental investigations and their translation into initial studies in humans, as well as community translation to promote evidence-based clinical practice. The BTRP continues to support the Sickle Cell Disease Scholars program for the career development of young investigators and the Summer-for-Sickle Cell-Science program for research training and mentoring of high-school students. These components are part of a larger effort by NHLBI to prepare the next generation of scientists to advance the field of SCD research.

Obligation

Fiscal Year 2010—$2,299,508

Current Active Organizations and Grant Numbers

  1. Children's Hospital and Research Center at Oakland
    Oakland, California —HL-070583
  2. Duke University
    Durham, North Carolina —HL-070769
  3. Children's Hospital Medical Center
    Cincinnati, Ohio —HL-070871
  4. Medical College of Wisconsin
    Milwaukee, Wisconsin —HL-090503

Cardiac Translational Research Implementation Program (C-TRIP) (P20)

The C-TRIP program, which consists of two stages, was initiated in FY 2010 to accelerate the translation of promising new therapeutic interventions derived from fundamental research discoveries for the treatment and prevention of heart failure or arrhythmias. Stage 1 focuses on planning and developing clinical trials to determine the safety and efficacy of interventions to be conducted during Stage 2 of the overall program. Stage 2 studies will be supported by the P50 mechanism.

Obligation

Fiscal Year 2010—$8,664,795

Current Active Organizations and Grant Numbers

  1. Mount Sinai School of Medicine
    New York, New York —HL-100396
  2. Johns Hopkins University
    Baltimore, Maryland —HL-101397
  3. Brigham and Women's Hospital
    Boston, Massachusetts —HL-101408
  4. University of Medicine and Dentistry of New Jersey
    New Jersey Medical School
    Newark, New Jersey —HL-101420
  5. Vanderbilt University
    Nashville, Tennessee —HL-101425
  6. University of Maryland, Baltimore
    Baltimore, Maryland —HL-101434
  7. University of Colorado, Denver
    Aurora, Colorado —HL-101435
  8. Texas Heart Institute
    Houston, Texas —HL-101438
  9. Mayo Clinic
    Rochester, Minnesota —HL-101439
  10. University of Miami School of Medicine
    Miami, Florida —HL-101443
  11. Children's Hospital of Philadelphia
    Philadelphia, Pennsylvania —HL-101820
  12. Brigham and Women's Hospital
    Boston, Massachusetts —HL-101866

Centers for AIDS Research Program (P30)

The NHLBI, along with five other NIH Institutes, contributes to the support of six Centers for AIDS Research that were established to provide a multidisciplinary environment that promotes basic, clinical, behavioral, and translational research activities in the prevention, detection, and treatment of HIV infection and AIDS. Almost half of the patient population comes from minority groups.

Obligations

Fiscal Year 2010—$3,368,475

Current Active Organizations and Grant Numbers

  1. New York University School of Medicine
    New York, New York —AI-027742
  2. University of Washington
    Seattle, Washington —AI-027757
  3. University of California, San Francisco
    San Francisco, California —AI-027763
  4. University of Alabama at Birmingham
    Birmingham, Alabama —AI-027767
  5. University of California, Los Angeles
    Los Angeles, California —AI-028697
  6. Baylor University
    Houston, Texas —AI-036211
  7. University of California, San Diego
    La Jolla, California —AI-036214
  8. Case Western Reserve University
    Cleveland, Ohio —AI-036219
  9. University of Massachusetts
    Medical School
    Worcester, Massachusetts —AI-042845
  10. Miriam Hospital
    Providence, Rhode Island —AI-042853
  11. University of Pennsylvania
    Philadelphia, Pennsylvania —AI-045008
  12. Emory University
    Atlanta, Georgia —AI-050409
  13. University of North Carolina
    at Chapel Hill
    Chapel Hill, North Carolina —AI-050410
  14. Yeshiva University
    New York, New York —AI-051519
  15. Vanderbilt University
    Nashville, Tennessee —AI-054999
  16. Harvard Medical School
    Boston, Massachusetts —AI-060354
  17. Duke University
    Durham, North Carolina —AI-064518
  18. University of Miami
    School of Medicine
    Coral Gables, Florida —AI-073961
  19. University of Rochester
    Rochester, New York —AI-078498
  20. Rush University Medical Center
    Chicago, Illinois —AI-082151
  21. George Washington University
    Washington, DC —AI-087714

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