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10. Research and Development Contracts

• NHLBI Total Research and Development Contract Obligations: Fiscal Years 1998–2008
• Major NHLBI Research and Development Contracts by Program
• Heart and Vascular Disease Program
• Lung Disease Program
• Blood Diseases and Resources Program

NHLBI Research and Development Contract Obligations:* Fiscal Years 1998–2008

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 1998–2008

Dollars (Thousands)

A Includes Program Evaluation and IMPAC II Assessments of $12,589,000.
B Includes Program Evaluation and IMPAC II Assessments of $14,904,000.
C Includes Program Evaluation and IMPAC II Assessments of $17,944,000.
D Includes Program Evaluation and IMPAC II Assessments of $24,579,000.
E Includes Program Evaluation and IMPAC II Assessments of $35,827,000.
F Includes Program Evaluation and IMPAC II Assessments of $54,550,000.
G Includes Program Evaluation and IMPAC II Assessments of $57,545,722.
H Includes Program Evaluation and IMPAC II Assessments of $64,399,000.
I Includes Program Evaluation and IMPAC II Assessments of $67,795,000.
J Includes Program Evaluation and IMPAC II Assessments of $68,405,000.
K Includes Program Evaluation and IMPAC II Assessments of $77,487,000.

Note: From 1999 to 2006 the WHI was reported separately. In this table, it has been incorporated in the "Heart" line.

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Major NHLBI Research and Development Contracts by Program

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Heart and Vascular Diseases Program

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

The ARIC is a large, longitudinal study that aims to measure associations of CHD risk factors with atherosclerosis by race, gender, and geographic location. It focuses on early detection of CVD before symptoms, heart attacks, or strokes occur. The project consists of two groups: a community surveillance in four communities and a cohort component of 15,792 participants from the same communities. Three of the cohort components represent the racial mix of their community, whereas the fourth is exclusively black.

In 2006, the study began conducting a community surveillance of inpatients (ages ≥55 years) and outpatients (ages ≥65 years) who have heart failure. The study will continue through 2009 to determine the number of heart failure events occurring during the 2005–2009 period.

Obligations

Funding History:
Fiscal Year 2008—$7,005,220
Fiscal Years 1985–2007—$135,395,804
Total Funding to Date—$142,401,024

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

Candidate Gene Association Resources, Initiated in Fiscal Year 2006

This program establishes a genotyping and bioinformatics center to perform high-throughput genotyping for candidate gene association studies in up to 50,000 participants, and a genome-wide association study in about 500 disease cases and 1,000 controls. The data will be combined with available phenotype data to form a genotype–phenotype resource for public use. DNA for the 50,000-person sample will be collected from multiple NHLBI cohort studies that have stored samples and available data on a wide array of heart, lung, blood, and sleep phenotypes.

Obligations

Funding History:
Fiscal Year 2008—$1,959,413
Fiscal Years 2006–2007—$16,261,517
Total Funding to Date—$18,220,930

Current Active Organization and Contract Number

1. Massachusetts Institute of Technology
   Cambridge, Massachusetts—HC-65226

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 elderly adults, 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 2008—$879,849
Fiscal Years 1988–2007—$77,171,177
Total Funding to Date—$78,051,026

Current Active Organization and Contract Number

1. University of Washington
   Seattle, Washington—HC-85239

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

CARDIA is a long-term study examining the evolution of CVD risk factors in a cohort of black and white adults, aged 18 to 30 years in 1985–1986. The study examines risk for heart and lung disease and diabetes by collecting information on body mass index, physical activity and lifestyle, genetics, serologic and metabolic components, inflammatory markers, and other subclinical markers of disease. Fifty percent of the participants are black.

Obligations

Funding History:
Fiscal Year 2008—$6,289,554
Fiscal Years 1984–2007—$82,239,746
Total Funding to Date—$88,529,300

Current Active Organizations and Contract Numbers

1. New England Medical Center
   Hospitals, Inc.
   Boston, Massachusetts—HC-45204
2. Wake Forest University Health Sciences
   Winston-Salem, North Carolina—HC-45205
3. University of Alabama at Birmingham
   Birmingham, Alabama—HC-48047
4. University of Minnesota, Twin Cities
   Minneapolis, Minnesota —HC-48048
5. Northwestern University
   Chicago, Illinois—HC-48049
6. Kaiser Permanente Division of Research
   Oakland, California—HC-48050
7. University of Alabama at Birmingham
   Birmingham, Alabama—HC-95095

DNA Resequencing and Genotyping, Initiated in Fiscal Year 2004

The purpose of this program is to obtain rapid, reliable, and cost-efficient DNA sequencing and genotyping of candidate genomic regions potentially important in the disease pathways of heart, lung, and blood diseases and sleep disorders. This information will assist ongoing investigations of genetic components involved in the causes, variable outcome, and progression of the diseases and disorders.

Obligations

Funding History:
Fiscal Year 2008—$1,352,366
Fiscal Years 2004–2007—$24,000,000
Total Funding to Date—$25,352,366

Current Active Organizations and Contract Numbers

1. University of Washington
   Seattle, Washington—HV-48194
2. Johns Hopkins University
   Baltimore, Maryland—HV-48195
3. J. Craig Venter Institute, Inc.
   Rockville, Maryland—HV-48196

Framingham Heart Study

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 these conditions at the outset. Of the original 5,209 subjects, about 500 members remain 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. A third-generation cohort consisting of approximately 4,000 grandchildren has been 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.

Obligations

Funding History:
Fiscal Year 2008—$23,134,059
Fiscal Years 1983–2007—$75,999,817
Total Funding to Date—$99,133,876

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 establish a national registry to enable investigators to determine the best medical practices to advance the clinical management of genetic thoracic aortic aneurysms and other cardiovascular complications associated with connective tissue diseases such as Marfan Syndrome.

Obligations

Funding History:
Fiscal Year 2008—$1,856,536
Fiscal Years 2006–2007—$2,951,713
Total Funding to Date—$4,808,249

Current Active Organization and Contract Number

1. Research Triangle Institute
   Research Triangle Park, North Carolina—HV-68199

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 the diseases. The program is supporting a multicenter, 6.5-year epidemiology study comprising approximately 16,000 participants (Mexican Americans, Puerto Ricans, Cuban Americans, and Central/South Americans, 4,000 at each of 4 sites), aged 18 to 74 years.

Obligations

Funding History:
Fiscal Year 2008—$15,615,264
Fiscal Years 2006–2007—$24,169,620
Total Funding to Date—$39,784,884

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

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

The JHS is a single-site, epidemiologic study of CVD in blacks, similar to established studies in Framingham, Massachusetts, and Honolulu, Hawaii, with primary goals of identifying risk factors for development and progression of CVD; enhancing retention; building research capabilities at minority institutions; developing partnerships between minority and majority institutions; and expanding minority investigator participation in large-scale, epidemiologic studies.

Obligations

Funding History:
Fiscal Year 2008—$4,694,251
Fiscal Years 1998–2007—$28,102,322
Total Funding to Date—$32,796,573

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, in a population that is 38 percent white, 28 percent black, 22 percent Hispanic, and 12 percent Asian. In 2007, the fourth cohort exam was completed and plans are underway for a fifth exam beginning in 2010 to continue periodic monitoring of participants to identify recent hospitalizations and other clinical events. Researchers seek to increase understanding of the basis for racial/ethnic difference in CVD.

Obligations

Funding History:
Fiscal Year 2008—$7,850,725
Fiscal Years 1999–2007—$68,667,692
Total Funding to Date—$76,518,417

Current Active Organizations and Contract Numbers

1. University of Washington
   Seattle, Washington—HC-95159
2. University of California, Los Angeles
   Los Angeles, California—HC-95160
3. Columbia University
   New York, New York—HC-95161
4. Johns Hopkins University
   Baltimore, Maryland—HC-95162
5. University of Minnesota, Twin Cities
   Minneapolis, Minnesota—HC-95163
6. Northwestern University
   Chicago, Illinois—HC-95164
7. Wake Forest University
   Winston-Salem, North Carolina—HC-95165
8. University of Vermont
   Colchester, Vermont—HC-95166
9. New England Medical Center
   Boston, Massachusetts—HC-95167
10. Johns Hopkins University
    Baltimore, Maryland—HC-95168
11. Harbor-UCLA Research and
    Education Institute
    Los Angeles, California —HC-95169

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 will support the production of safe and well-characterized vectors; conduct extensive toxicology and pharmacology studies on animals to determine vector dosing, related toxicity, and vector dissemination; and provide investigators with regulatory assistance to initiate a clinical trial. The GTRP also will support a maximum of two phase I/II gene transfer clinical trials per year that have successfully met all regulatory requirements and are ready to enroll patients within 12 months of application approval.

Obligations

Funding History:
Fiscal Year 2008—$5,900,000
Fiscal Year 2007—$5,900,000
Total Funding to Date—$11,800,000

Current Active Organizations and Contract Numbers

1. Social and Scientific Systems, Inc.
   Silver Spring, Maryland—HV-78200
2. Lovelace Biomedical Research &
   Education Institute
   Albuquerque, New Mexico—HV-78201
3. University of Pennsylvania
   Philadelphia, Pennsylvania—HV-78202
4. Children's Hospital of Philadelphia
   Philadelphia, Pennsylvania—HV-78203
5. Indiana University
   Indianapolis, Indiana—HV-78204

Pediatric Circulatory Support, Initiated in Fiscal Year 2004

The purpose of this program is to establish multidisciplinary teams to develop innovative circulatory assist devices or other bioengineered systems for infants and children with congenital and acquired CVD who experience cardiopulmonary failure and circulatory collapse.

Obligations

Funding History:
Fiscal Year 2008—$5,357,682
Fiscal Years 2004–2007—$16,837,343
Total Funding to Date—$22,195,025

Current Active Organizations and Contract Numbers

1. Cleveland Clinic
   Lerner College of Medicine
   Cleveland, Ohio—HV-48188
2. Ension, Inc.
   Pittsburgh, Pennsylvania—HV-48189
3. Jarvik Heart, Inc.
   New York, New York—HV-48190
4. Pennsylvania State University
   Hershey, Pennsylvania—HV-48191
5. University of Pittsburgh
   Pittsburgh, Pennsylvania—HV-48192

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. Scientists will focus on the cells' protein machinery directed toward understanding the molecular basis of the causes and progression of heart, lung, and blood diseases and sleep disorders and identifying targets for therapeutic interventions.

Obligations

Funding History:
Fiscal Year 2008—$41,727,195
Fiscal Years 2002–2007—$115,878,890
Total Funding to Date—$157,606,085

Current Active Organizations and Contract Numbers

1. Boston University
   Boston, Massachusetts—HV-28178
2. Institute for Systems Biology
   Seattle, Washington—HV-28179
3. Johns Hopkins University
   Baltimore, Maryland—HV-28180
4. Medical University of South Carolina
   Charleston, South Carolina—HV-28181
5. Medical College of Wisconsin
   Milwaukee, Wisconsin—HV-28182
6. Stanford University
   Stanford, California—HV-28183
7. University of Texas
   Galveston, Texas—HV-28184
8. University of Texas
   Southwestern Medical Center
   Dallas, Texas—HV-28185
9. Yale University
   New Haven, Connecticut—HV-28186
10. Henry M. Jackson Foundation for the
    Advancement of Military Medicine, Inc.
    Rockville, Maryland—HV-28187

Randomized Trial of Genotype-Guided Dosing of Warfarin Therapy, Initiated in Fiscal Year 2008

The purpose of this multicenter, double-blind, randomized trial is to compare three approaches to guiding warfarin therapy initiation: one based on an algorithm using clinical information and the individual's genotype relative to two genes known to influence warfarin metabolism (CYP2C9 and VKORC1 genes); one based on an algorithm using only clinical information; and one based on a standard, guideline-based initiation strategy. The trial will randomize approximately 2,000 participants with any indication for chronic long-term anticoagulation and no previous treatment with warfarin.

Obligations:

Funding History:
Fiscal Year 2008—$2,637,062
Total Funding to Date—$2,637,062

Current Active Organization and Contract Number

1. University of Pennsylvania
   Philadelphia, Pennsylvania—HV-88210

Registry for Mechanical Circulatory Support, Initiated in Fiscal Year 2005

The purpose of this program is to establish a data and clinical coordinating center to manage a registry of patients receiving a mechanical circulatory support device (MCSD) to treat heart failure. The registry will collect and analyze clinical and laboratory data and tissue samples from patients who receive MCSDs as destination therapy for end-stage heart failure at 60 to 70 participating hospitals.

Obligations

Funding History:
Fiscal Year 2008—$1,314,180
Fiscal Years 2005–2007—$3,747,718
Total Funding to Date—$5,061,898

Current Active Organization and Contract Number

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

Lung Diseases Program

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 seek to improve management of lung diseases by increasing understanding of the pathogenetic mechanisms of lung diseases through molecular histopathological studies on tissues with and without disease. Primary emphases are on COPD and idiopathic pulmonary fibrosis.

Obligations

Funding History:
Fiscal Year 2008—$776,166
Fiscal Years 2004–2007—$23,098,806
Total Funding to Date—$23,874,972

Current Active Organizations and Contract Numbers

1. Mayo Clinic College of Medicine
   Rochester, New York—HR-46158
2. University of Colorado
   Health Science Center
   Denver, Colorado—HR-46159
3. University of Michigan
   Ann Arbor, Michigan—HR-46162

Tuberculosis Curriculum Coordinating Center, Initiated in Fiscal Year 2003

The purpose of this program is to establish a consortium of five Tuberculosis Curriculum Centers to strengthen and increase access to the best ongoing educational and training opportunities in TB for medical, nursing, and allied health schools, especially those that provide primary care to communities where TB is endemic and the population is at high risk.

Obligations

Funding History:
Fiscal Year 2008—$1,125,000
Fiscal Years 2003–2007—$4,875,000
Total Funding to Date—$6,000,000

Current Active Organization and Contract Number

1. University of California, San Diego
   La Jolla, California—HR-36157

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, as well as administers safe shipment of precise sample aliquots to approved investigators for future studies.

Obligations

Funding History:
Fiscal Year 2008—$3,560,582
Fiscal Years 1998–2007—$9,807,153
Total Funding to Date—$13,367,735

Current Active Organization and Contract Number

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

Retrovirus Epidemiology Donor Study-II (REDS-II), Initiated in Fiscal Year 2005

The purpose of the program is to conduct epidemiologic, laboratory, and survey research on volunteer blood donors within the United States to ensure the safety and availability of the blood supply. The study seeks to assess the prevalence and incidence of existing as well as newly discovered infectious agents that pose a threat to blood safety; evaluate characteristics and behaviors of voluntary blood donors; determine the causes of adverse transfusion reactions of unknown etiology; assess new and existing blood donor screening methodologies; assess the impact of new blood bank technologies on blood safety and availability; and evaluate the donation process for ways to improve the adequacy of the blood supply.

An international component was added to conduct epidemiologic, laboratory, and survey research on blood donors in China and Brazil, two countries seriously affected by the AIDS epidemic, to ensure the availability and safety of blood for transfusion.

Obligations

Funding History:
Fiscal Year 2008—$6,729,971
Fiscal Years 2005–2007—$30,483,895
Total Funding to Date—$37,213,866

Current Active Organizations and Contract Numbers

1. Blood Center of Southeastern Wisconsin
   Milwaukee, Wisconsin—HB-47168
2. American Red Cross Blood Service,
   New England
   Farmington, Connecticut—HB-47169
3. Emory University
   Atlanta, Georgia—HB-47170
4. University of Cincinnati
   Cincinnati, Ohio—HB-47171
5. Institute for Transfusion Medicine
   Pittsburgh, Pennsylvania—HB-47172
6. University of California, San Francisco
   San Francisco, California—HB-47174
7. Westat, Inc.
   Rockville, Maryland—HB-47175
8. Blood System Research, Inc.
   San Francisco, California—HB-57181

Sickle Cell Disease Health-Related Quality of Life Questionnaire, Initiated in Fiscal Year 2005

The purpose of this project is to develop a psychometrically sound and clinically useful health-related quality-of-life instrument and related materials for use in sickle cell clinical trials and outcomes research among adults with SCD, and to assist researchers who are early users of the instrument and materials.

Obligations

Funding History:
Fiscal Year 2008—$3,701,968
Fiscal Years 2005–2007—$1,471,008
Total Funding To Date—$5,172,976

Current Active Organization and Contract Number

1. American Institutes for Research
   Health Program
   Silver Spring, Maryland—HL-54264

Somatic Cell Therapy Processing Facilities, Initiated in Fiscal Year 2003

This program is designed to develop novel somatic cellular therapies in areas ranging from basic science through animal studies to proof-of-principle and eventually human trials for heart, lung, and blood diseases and sleep disorders. The goal is to provide rapid, safe translation of basic research ideas into clinical practice.

Obligations

Funding History:
Fiscal Year 2008—$18,191
Fiscal Years 2003–2007—$21,732,735
Total Funding to Date—$21,750,926

Current Active Organizations and Contract Numbers

1. Baylor College of Medicine
   Houston, Texas—HB-37163
2. University of Minnesota, Twin Cities
   Minneapolis, Minnesota—HB-37164
3. University of Pittsburgh
   Pittsburgh, Pennsylvania—HB-37165
4. The EMMES Corporation
   Rockville, Maryland—HB-37166

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