10. Research and Development Contracts

• NHLBI Total Research and Development Contract Obligations: Fiscal Years 2001–2011
• Major NHLBI Research and Development Contracts by Program
• Heart and Vascular Disease
• Lung Disease
• Blood Diseases and Resources

NHLBI Total Research and Development Contract Obligations:*  Fiscal Years 2001–2011

Text-only With Data Points

* For detailed data on contract-supported clinical trials, see Chapter 11.

NHLBI Total Research and Development Contract Obligations: Fiscal Years 2001–2011

Dollars (Thousands)

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Major NHLBI Research and Development Contracts by Program

* Formerly known as Retrovirus Epidemiology Donor Study.

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Heart and Vascular Diseases

Action To Control Cardiovascular Risk in Diabetes Follow-Up Study (ACCORDION), Initiated in Fiscal Year 2011

The purpose of the follow-up observational study (ACCORDION) is to obtain long-term (10 year average) data on ACCORD participants.  Investigators are seeking to determine whether differences in mortality, CVD events, and microvascular diseases identified during the ACCORD trial persist or change over time and whether other differences will emerge. They will monitor long-term vascular outcomes from diabetes and the effects of glucose, blood pressure lowering, and lipid treatment on those outcomes.

ACCORD was a randomized clinical trial to evaluate the ability of three treatment strategies (intensive glycemic control, intensive blood pressure control, and fibrate treatment to raise HDL-cholesterol and lower triglycerides) to prevent major CVD events in patients with type 2 diabetes who were at high risk of CVD.

After a mean 3.5 years of treatment, the intensive glycemic portion of the trial was stopped because patients in the intensive glycemic treatment group had an increased risk of all-cause mortality compared with patients in the standard treatment group even though they had a non-statistically significant 10 percent reduction in the composite primary outcome of nonfatal MI, nonfatal stroke, or CVD death. Participants in the intensive group were then transitioned to the standard treatment strategy. Initial follow-up found no overall benefit of intensive treatment (intensive blood pressure control or fibrate and statin) over standard treatment (normal blood pressure or statin).

Obligations

Funding History:
Fiscal Year 2011—$13,250,149
Total Funding to Date—$13,250,149*

* Total funding for ACCORD was $142,587,546 from 1999 to 2010.

Current Active Organizations and Contract Numbers

1. Veterans Affairs Medical Center, Albuquerque
   Albuquerque, New Mexico —HC-10100
2. Veterans Affairs Medical Center, Memphis
   Memphis, Tennessee —HC-90350
3. Wake Forest University
   Winston-Salem, North Carolina   —HC-95178
4. McMaster University
   Hamilton, Ontario —HC-95179
5. University of Washington
   Seattle, Washington   —HC-95180
6. Case Western Reserve University
   Cleveland, Ohio —HC-95181
7. Wake Forest University
   Winston-Salem, North Carolina   —HC-95182
8. Minneapolis Medical Research Foundation
   Minneapolis, Minnesota   —HC-95183
9. Trustees of Columbia University of  New York
   New York, New York —HC-95184

Atherosclerosis Risk in Communities (ARIC), Initiated in Fiscal Year 1985

The ARIC is an epidemiology study comprising a prospective cohort component and a community surveillance component. The cohort component investigates the etiology of CHD and stroke in 15,792 participants, aged 46–64 years at baseline, by race and gender in four U.S. communities. The community surveillance component monitors trends in hospitalized myocardial infarction, fatal CHD, and heart failure (2005–2009) from the same communities.

In 2011, the study began to reexamine the cohort participants with a focus on heart failure—a major epidemic in the rapidly aging U.S. population. Three of the cohort components represent the racial mix of their respective communities, and the fourth is exclusively black.

Obligations

Funding History:
Fiscal Year 2011—$15,012,384
Fiscal Years 1985–2010—$157,168,999
Total Funding to Date—$172,181,383

Current Active Organizations and Contract Numbers

1. University of North Carolina at Chapel Hill
   Chapel Hill, North Carolina —HC-55015
2. Baylor College of Medicine
   Houston, Texas  —HC-55016
3. University of North Carolina at Chapel Hill
   Chapel Hill, North Carolina —HC-55018
4. University of Minnesota, Twin Cities
   Minneapolis, Minnesota —HC-55019
5. Johns Hopkins University
   Baltimore, Maryland —HC-55020
6. Mississippi Medical Center
   Jackson, Mississippi —HC-55021
7. Brigham and Women’s Hospital
   Boston, Massachusetts —HC-55273

Cardiovascular Health Study (CHS), Initiated in Fiscal Year 1988

The CHS is a population-based, longitudinal study of risk factors for development and progression of CHS and stroke in the elderly, 17 percent of whom are from minority populations. Extensive data and samples have been collected from nearly 6,000 participants since 1989–1990. The current CHS:  Transition Phase provides partial support for an infrastructure to enable continued access to study resources and expertise, scientific collaborations, and mentorship of early-career investigators. 

Obligations

Funding History:
Fiscal Year 2011—$576,600
Fiscal Years 1988–2010—$79,555,913
Total Funding to Date—$80,132,513

Current Active Organization and Contract Number

1. University of Washington
   Seattle, Washington  —268200800007C

Coronary Artery Risk Development in Young Adults (CARDIA), Initiated in Fiscal Year 1984

The CARDIA is a long-term study that examines the evolution of CVD risk factors and early clinical events in persons aged 18–30 years in 1985–1986. The study examines risk factors for heart and lung diseases by collecting information on body mass index, physical activity and lifestyle, genetics, cognitive functioning, serologic and metabolic components, inflammatory markers, and other subclinical measures of disease. Fifty percent of the participants are black.

Obligations

Funding History:
Fiscal Year 2011—$9,901,825
Fiscal Years 1984–2010—$99,138,459
Total Funding to Date—$109,040,284

Current Active Organizations and Contract Numbers

1. Johns Hopkins University
   Baltimore, Maryland —HC-45241
2. University of Alabama at Birmingham
   Birmingham, Alabama —HC-48047
3. University of Minnesota, Twin Cities
   Minneapolis, Minnesota  —HC-48048
4. Northwestern University
   Chicago, Illinois  —HC-48049
5. Kaiser Permanente Division of Research
   Oakland, California —HC-48050
6. University of Alabama at Birmingham
   Birmingham, Alabama —HC-95095

DNA Resequencing and Genotyping Program, Initiated in Fiscal Year 2004

The purpose of this program is to provide high-quality, high-volume resequencing and genotyping of candidate genomic regions potentially important in the disease pathways of heart, lung, and blood diseases and sleep disorders. The information obtained will enable ongoing investigations to elucidate the specific genetic components involved in the causes for, variable outcomes of, and progression of the diseases and disorders.

Obligations

Funding History:
Fiscal Year 2011—$9,274,939
Fiscal Years 2004–2010—$29,209,023
Total Funding to Date—$38,483,962

Current Active Organizations and Contract Numbers

1. Systems Research and Applications International, Inc.
   Rockville, Maryland —268201100029C
2. University of Washington
   Seattle, Washington  —268201100037C

Framingham Heart Study (FHS), Initiated in Fiscal Year 1948

The original Framingham Heart Study was designed as a longitudinal investigation of constitutional and environmental factors influencing the development of CVD in individuals free of CVD symptoms at the outset. Of the original 5,209 participants, about 150 are still alive. In 1971, the Framingham Offspring Study was initiated to assess familial and genetic factors associated with CHD. More than 5,000 offspring (and their spouses) were included.  In 2002, a third-generation cohort consisting of approximately 4,000 grandchildren was added to permit examination of numerous hypotheses about the genetic contribution to CVD and CVD risk factors. Additional goals include identifying new risk factors for cardiovascular, lung, and blood diseases and developing new imaging tests that can detect very early stages of coronary atherosclerosis in otherwise healthy adults.

In 2009, the Omni Group 1 and Omni Group 2 cohorts were integrated into the NHLBI contract for the FHS. The Omni cohorts consist of minority residents of Framingham, Massachusetts (about 500 and 400 participants in Omni Group 1 and Omni Group 2, respectively), and were previously identified, recruited, and examined through NHLBI investigator-initiated grants. They were added to the FHS to reflect the growing diversity of the community.

Obligations

Funding History:
Fiscal Year 2011—$16,664,505
Fiscal Years 1983–2010—$115,709,281
Total Funding to Date—$132,373,786

Current Active Organization and Contract Number

1. Boston University Medical Center
   Boston, Massachusetts —HC-25195

Genetically Triggered Thoracic Aortic Aneurysms and Other Cardiovascular Conditions (GenTAC):  National Registry, Initiated in Fiscal Year 2006

The purpose of this program is to improve the diagnosis and management of patients with thoracic aortic aneurysms and other cardiovascular complications associated with connective tissue diseases, such as Marfan, Loeys-Dietz, and Ehlers Danlos (vascular type) Syndromes. The GenTAC is establishing a medical database and biospecimens repository as a resource for qualified investigators to study the link between genes and aortic aneurysms and heart disease.

Obligations

Funding History:
Fiscal Year 2011—$3,763,038
Fiscal Years 2006–2010—$11,115,085
Total Funding to Date—$14,878,123

Current Active Organization and Contract Number

1. Research Triangle Institute International
   Research Triangle Park, North Carolina  —HV-08238

Global Health Centers of Excellence, Initiated in Fiscal Year 2009

The purpose of this program is to support a worldwide network of research and training centers to prevent and control chronic cardiovascular and pulmonary diseases in developing countries.  The NHLBI joined with Minneapolis-based UnitedHealth Group’s Chronic Disease Initiative in establishing the UnitedHealth and NHLBI Collaborating Centers of Excellence network. Each center is led by a research institution in a developing country that is paired with at least one partner academic institution in a developed country to enhance research and training opportunities.

Obligations

Funding History
Fiscal Year 2011—$2,607,272
Fiscal Years 2009–2010—$14,399,764
Total Funding to Date—$17,007,036

Current Active Organizations and Contract Numbers

1. The George Institute for International Health, China
   Beijing, China —HV-98217
2. Instituto de Nutrición de Centro América y Panamá
   Guatemala City, Guatemala  —HV-98218
3. University of Cape Town
   Cape Town, South Africa —HV-98220
4. Moi University School of Medicine
   Eldoret, Kenya  —HV-98221
5. Universidad Peruana Cayetano Heredia
   Lima, Peru —HV-98223

Hispanic Community Health Study (HCHS), Initiated in Fiscal Year 2006

The purpose of this program is to determine the prevalence of and risk factors for cardiovascular and lung diseases in Hispanic populations and the role of cultural adaptation and disparities in development of these and other chronic diseases. The multicenter, 6.5-year epidemiology study comprises more than 16,400 Hispanics, aged 18–74 years, who self-identify as being of Mexican, Puerto Rican, Cuban, Dominican, or Central or South American heritage.

Obligations

Funding History:
Fiscal Year 2011—$5,175,848
Fiscal Years 2006–2010—$51,468,540
Total Funding to Date—$56,644,388

Current Active Organizations and Contract Numbers

1. University of North Carolina at Chapel Hill
   Chapel Hill, North Carolina —HC-65233
2. University of Miami
   Miami, Florida  —HC-65234
3. Albert Einstein College of Medicine
   New York, New York —HC-65235
4. Northwestern University
   Chicago, Illinois  —HC-65236
5. San Diego State University
   San Diego, California —HC-65237

Interagency Registry for Mechanical Circulatory Support (INTERMACS), Initiated in Fiscal Year 2005

The INTERMACS is a national registry for patients who are receiving mechanical circulatory support device (MCSD) therapy to treat advanced heart failure. The registry collects and analyzes clinical and laboratory data and tissue samples from patients who receive MCSDs as destination therapy for end-stage heart failure at 119 participating sites.

Obligations

Funding History:
Fiscal Year 2011—$5,299,999
Fiscal Years 2005–2010—$7,826,196
Total Funding to Date—$13,126,195

Current Active Organization and Contract Number

1. University of Alabama
   Birmingham, Alabama   —HV-58198

Jackson Heart Study (JHS), Initiated in Fiscal Year 1998

The JHS is an epidemiologic study of CVD in blacks in Jackson, Mississippi, similar to established studies in Framingham, Massachusetts, and Honolulu, Hawaii. The goal of the study is to identify factors related to the development and progression of CVD in blacks. The JHS conducts a variety of community education and outreach activities to promote healthy lifestyles to reduce disease burden. In addition, the JHS seeks to build research capabilities in minority institutions, address the critical shortage of minority investigators in epidemiology and prevention, and reduce barriers to dissemination and use of health information in a minority population.

Obligations

Funding History:
Fiscal Year 2011—$4,882,541
Fiscal Years 1998–2010—$38,494,257
Total Funding to Date—$43,376,798

Current Active Organizations and Contract Numbers

1. Jackson State University
   Jackson, Mississippi   —HC-95170
2. Mississippi Medical Center
   Jackson, Mississippi   —HC-95171
3. Tougaloo College
   Tougaloo, Mississippi   —HC-95172

Multi-Ethnic Study of Atherosclerosis (MESA), Initiated in Fiscal Year 1999

The purpose of this study is to investigate the prevalence, correlates, and progression of subclinical CVD (i.e., disease detected noninvasively before it has produced clinical signs and symptoms). The cohort of 6,814 participants is 38 percent white, 28 percent black, 22 percent Hispanic, and 12 percent Asian. A fifth examination, completed in November 2011, included a repeat measurement of cardiac function with MRI to assess changes over time.  Periodic monitoring of participants to identify recent hospitalizations and other clinical events will continue.

Obligations

Funding History:
Fiscal Year 2011—$5,815,507
Fiscal Years 1999–2010—$102,979,420
Total Funding to Date—$108,794,927

Current Active Organizations and Contract Numbers

1. University of Washington
   Seattle, Washington —HC-95159
2. Johns Hopkins University
   Baltimore, Maryland —HC-95162
3. University of Vermont
   Colchester, Vermont  —HC-95166
4. Johns Hopkins University
   Baltimore, Maryland —HC-95168

NHLBI Gene Therapy Resource Program (GTRP), Initiated in Fiscal Year 2007

The purpose of this program is to promote the translation of basic research into clinical trials. The program provides resources in the form of preclinical and clinical-grade vector production; pharmacology and toxicology testing on animals; immunology testing; clinical trials funding assistance; and regulatory support for gene therapy research primarily in heart, lung, and blood diseases.

Obligations

Funding History:
Fiscal Year 2011—$7,435,505
Fiscal Years 2008–2010—$21,753,472
Total Funding to Date—$29,188,977

Current Active Organizations and Contract Numbers

1. Social and Scientific Systems, Inc.
   Silver Spring, Maryland —HV-78200
2. University of Pennsylvania
   Philadelphia, Pennsylvania —HV-78202
3. Children’s Hospital of Philadelphia
   Philadelphia, Pennsylvania —HV-78203
4. Indiana University
   Indianapolis, Indiana —HV-78204

NHLBI Programs of Excellence in Nanotechnology,* Initiated in Fiscal Year 2010

* NHLBI Programs of Excellence in Nanotechnology was a cooperative agreement from 2005 to 2009.

The purpose of this program is to support multidisciplinary teams to develop nanotechnology and biomolecular engineering tools and methodologies for the diagnosis and treatment of heart, lung, and blood diseases. The focus of this phase of the program is to translate the technologies being developed toward clinical application. The program brings together bioengineers, chemists, material scientists, biologists, and clinicians across 17 institutions for unique scientific collaborations and skills development opportunities.

Obligations

Funding History:
Fiscal Year 2011—$966,068
Fiscal Year 2010—$65,777,271
Total Funding to Date—$66,743,339

Current Active Organization and Contract Number

1. Washington University
   St. Louis, Missouri  —268201000046C

Proteomics Initiative, Initiated in Fiscal Year 2002

The purpose of this program is to establish highly interactive, multidisciplinary centers to enhance and develop innovative proteomic technologies directed to relevant biologic questions associated with heart, lung, blood, and sleep health and disease.

Obligations

Funding History:
Fiscal Year 2011—$17,123,612
Fiscal Years 2002–2010—$174,518,757
Total Funding to Date—$191,642,369

Current Active Organizations and Contract Numbers

1. Boston University
   Boston, Massachusetts —268201000031C
2. Johns Hopkins University
   Baltimore, Maryland   —268201000032C
3. Massachusetts General Hospital
   Boston, Massachusetts —268201000033C
4. Stanford University
   Stanford, California —268201000034C
5. University of California, Los Angeles
   Los Angeles, California —268201000035C
6. University of Texas
   San Antonio, Texas   —268201000036C
7. University of Texas
   Galveston, Texas  —268201000037C

Pumps for Kids, Infants, and Neonates (PumpKIN), Initiated in Fiscal Year 2010

The purpose of this program is to support technologies that will expand life-saving options for infants and children who are born with congenital heart defects or those who develop heart failure. Investigators are seeking to complete animal studies and other preclinical tests for the most promising devices in order to gain approval from the FDA to begin clinical testing.

Obligations

Funding History:
Fiscal Year 2011—$10,163,382
Fiscal Year 2010—$8,388,522
Total Funding to Date—$18,551,904

Current Active Organizations and Contract Numbers

1. University of Pittsburgh
   Pittsburgh, Pennsylvania —268201000012C
2. Jarvik Heart, Inc.
   New York, New York —268201000013C
3. University of Maryland
   Baltimore, Maryland —268201000014C
4. Ension, Inc.
   Pittsburgh, Pennsylvania —268201000015C

Science Moving TowArds Research Translation and Therapy Program (SMARTT), Initiated in Fiscal Year 2011

The purpose of this program is to support the transition of potential new therapies for heart, lung, and blood diseases from discovery in the lab to the testing needed to establish their safety and effectiveness in people.  The SMARTT program provides tailored pharmacology and toxicology testing, manufacturing services, and regulatory support to investigators to expedite the transition of their discoveries to the clinic.

Obligations

Funding History:
Fiscal Year 2011—$4,145,344
Total Funding to Date—$4,145,344

Current Active Organizations and Contract Numbers

1. Advanced BioScience Laboratories, Inc.
   Rockville, Maryland —268201100014C
2. SRI International
   Menlo Park, California  —268201100015C
3. Research Triangle Institute International
   Research Triangle Park, North Carolina —268201100016C
4. SRI International
   Menlo Park, California —268201000017C

Lung Diseases

Lung Tissue Research Consortium, Initiated in Fiscal Year 2004

The purpose of this program is to establish a consortium for collecting lung tissues and preparing and distributing them for research. Scientists are seeking to improve management of lung diseases by increasing understanding of the pathogenetic mechanisms of lung diseases through molecular histopathological studies of tissues with and without disease. Primary emphases are on COPD and idiopathic pulmonary fibrosis.

Obligations

Funding History:
Fiscal Year 2011—$7,852,716
Fiscal Years 2004–2010—$30,000,000
Total Funding to Date—$37,852,716

Current Active Organizations and Contract Numbers

1. University of Colorado Health Science Center
   Denver, Colorado  —HR-46159
2. University of Michigan
   Ann Arbor, Michigan —HR-46207
3. Mayo Clinic College of Medicine
   Rochester, New York —HR-46208
4. University of Pittsburgh
   Pittsburgh, Pennsylvania —HR-46210
5. Clinical Trials and Survey Corporation
   Baltimore, Maryland —HR-46211
6. Mayo Clinic College of Medicine
   Rochester, New York —HR-46212

Subpopulations and Intermediate Outcome Measures in COPD Study (SPIROMICS), Initiated in Fiscal Year 2009

The purposes of this study are to define pathogenetically homogeneous subgroups of COPD subjects on the basis of biomarkers, genotypes, and computed tomography images and to identify immediate outcome measures for use in future clinical studies. Secondary aims are to clarify the natural history of COPD; develop bioinformatic resources that will enable the use and sharing of data in studies of COPD and related diseases; and create a collection of clinical, biomarker, radiographic, and genetic data that can be used by external investigators for other studies of COPD.

Obligations

Funding History:
Fiscal Year 2011—$2,655,398
Fiscal Years 2009–2010—$30,042,319
Total Funding to Date—$32,697,717

Current Active Organizations and Contract Numbers

1. University of California, San Francisco
   San Francisco, California —HR-96199
2. University of California, Los Angeles
   Los Angeles, California   —HR-96200
3. Columbia University
   New York, New York —HR-96201
4. University of Michigan
   Ann Arbor, Michigan —HR-96202
5. University of Utah
   Salt Lake City, Utah —HR-96203
6. Wake Forest University
   Winston-Salem, North Carolina   —HR-96204
7. University of North Carolina, Chapel Hill
   Chapel Hill, North Carolina —HR-96206

Blood Diseases and Resources Program

Maintenance of NHLBI Biological Specimen Repository, Initiated in Fiscal Year 1998

The purpose of this project is to establish an NHLBI Biological Specimen Repository for blood specimens from Institute-supported research. The Repository monitors storage, labeling, and testing of the specimens, and administers safe shipment of precise sample aliquots to approved investigators for future studies.

Obligations

Funding History:
Fiscal Year 2011—$3,209,369
Fiscal Years 1998–2010—$19,332,708
Total Funding to Date—$22,542,077

Current Active Organization and Contract Number

1. SeraCare Life Sciences, Inc.
   Rockville, Maryland —HB-87144

NHLBI–CDC Registry and Surveillance System in Hemoglobinopathies (RuSH), Initiated in Fiscal Year 2009

The purpose of this pilot program is to test the feasibility of developing a national data system that will enable investigators to estimate the number of people who have SCD, thalassemias, and hemoglobinopathies and to describe their sociodemographic characteristics. The Institute, along with the CDC, has created newborn screening programs with State health departments in California, Florida, Georgia, Michigan, New York, North Carolina, and Pennsylvania.

Obligations

Funding History:
Fiscal Year 2011—$4,208,761
Fiscal Year 2010—$6,419,918
Total Funding to Date—$10,628,679

Current Active Organization and Contract Number

1. Centers for Disease Control and Prevention
   Atlanta, Georgia  —HR-9045

Production Assistance for Cellular Therapies (PACT), Initiated in Fiscal Year 2010

The purpose of this program is to facilitate the transfer of innovative cellular therapies from the bench to the bedside. The PACT offers assistance to investigators in areas ranging from translational development to production of a product for use in human clinical trials.

Obligations

Funding History:
Fiscal Year 2011—$11,472,212
Fiscal Year 2010—$10,826,333
Total Funding to Date—$22,298,545

Current Active Organizations and Contract Numbers

1. EMMES Corp.
   Rockville, Maryland —268201000006C
2. Baylor College of Medicine
   Houston, Texas  —268201000007C
3. University of Minnesota
   Minneapolis, Minnesota —268201000008C
4. Immune Disease Institutes
   Boston, Massachusetts  —268201000009C
5. University of Wisconsin
   Madison, Wisconsin  —268201000010C
6. Beckman Research Institutes
   Duarte, California—268201000011C

Recipient Epidemiology and Donor Study-III (REDS-III),* Initiated in Fiscal Year 2011

* Formerly known as Retrovirus Epidemiology Donor Study. REDS: Total funding for FY 1989–2004, $73,774,125. REDS II: Total funding for FY 2005–2010, $53,016,894.

The purpose of this program is to conduct research to improve transfusion practices and the safety and adequacy of the blood supply in the United States and in countries affected by the AIDS epidemic. The domestic component consists of four research hubs, and the international component consists of collaborators from blood centers in Brazil, China, and South Africa.

Building on the findings of previous REDS and REDS II programs, the REDS-III international program focuses on identifying ways to reduce and prevent the transmission of HIV/AIDS and other known and emerging infectious agents through transmission.

Obligations

Funding History:
Fiscal Year 2011—$19,910,527
Total Funding to Date—$1,910,527

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