U01HL160272
Cooperative Agreement
Overview
Grant Description
Wake Forest Atrium Heartshare Clinical Center - Project Summary
Heart failure with preserved ejection fraction (HFPEF) is the most common form of HF in the US and is associated with high morbidity and mortality. However, its pathophysiology is incompletely understood, and most trials have been neutral such that few evidence-based treatments exist.
In response, NIH convened 2 workshops co-led by Dr. Kitzman (PI). The highest priority research recommendation was a coordinated effort to create a large cohort of HFPEF patients and controls and perform comprehensive, deep phenotyping. This became the basis for Heartshare, whose ultimate goals are to discover novel HFPEF mechanisms, subtypes, and therapeutic targets.
Our Wake Forest - Atrium HFPEF team is highly qualified to serve as a clinical center and make robust, over-arching contributions to Heartshare. Dr. Kitzman is internationally recognized as a thought-leader in HFPEF with a sustained track record of developing novel concepts regarding HFPEF pathogenesis, mechanisms, and outcomes and designing and conducting innovative studies to test them. His team has extensive experience in all key aspects of the Heartshare program, particularly in recruiting, retaining, and phenotyping diverse populations of HFPEF patients and controls, often significantly exceeding goals for racial and gender diversity.
Our institutions have ~15,000 HFPEF clinical visits annually. In all, our team has led or helped lead recruitment and phenotyping for 69 studies, mostly NIH-sponsored, with 15,354 participants, demonstrating our ability to fulfill Heartshare recruitment and phenotyping goals. Data from these studies will be contributed to the cohort phase of Heartshare.
We will make robust contributions to Heartshare by achieving 4 specific aims:
Aim 1) Provide 'thought leadership' in collaboration with the Heartshare Steering Committee;
Aim 2) Contribute data, images, and stored specimens cohort phase of Heartshare from our numerous studies of HFPEF and controls, and identify and phenotype HFPEF patients and controls from the electronic health record using robust bioinformatics tools;
Aim 3) Recruit, consent, enroll and follow at least 250 HFPEF patients plus controls (type and number to be determined by consensus);
Aim 4) Conduct state-of-the-art deep phenotyping exams using a collaboratively determined protocol.
Our phenotyping proposal is highly innovative, with advanced echo-Doppler and cardiac magnetic resonance imaging, CPET, physical activity monitoring, remote and artificial intelligence electrocardiography, sampling of skeletal muscle, adipose, blood, and microbiome, and mitochondrial energetics, and brain structure/function.
Our diverse, cross-disciplinary team has the full range of complementary expertise and access to the robust resources of two large, closely affiliated health systems to ensure fulfillment of all Heartshare's goals. We will help accelerate and optimize the program's success with our insight, creativity, and sustained track record of collaboration, innovation, and dissemination.
Heart failure with preserved ejection fraction (HFPEF) is the most common form of HF in the US and is associated with high morbidity and mortality. However, its pathophysiology is incompletely understood, and most trials have been neutral such that few evidence-based treatments exist.
In response, NIH convened 2 workshops co-led by Dr. Kitzman (PI). The highest priority research recommendation was a coordinated effort to create a large cohort of HFPEF patients and controls and perform comprehensive, deep phenotyping. This became the basis for Heartshare, whose ultimate goals are to discover novel HFPEF mechanisms, subtypes, and therapeutic targets.
Our Wake Forest - Atrium HFPEF team is highly qualified to serve as a clinical center and make robust, over-arching contributions to Heartshare. Dr. Kitzman is internationally recognized as a thought-leader in HFPEF with a sustained track record of developing novel concepts regarding HFPEF pathogenesis, mechanisms, and outcomes and designing and conducting innovative studies to test them. His team has extensive experience in all key aspects of the Heartshare program, particularly in recruiting, retaining, and phenotyping diverse populations of HFPEF patients and controls, often significantly exceeding goals for racial and gender diversity.
Our institutions have ~15,000 HFPEF clinical visits annually. In all, our team has led or helped lead recruitment and phenotyping for 69 studies, mostly NIH-sponsored, with 15,354 participants, demonstrating our ability to fulfill Heartshare recruitment and phenotyping goals. Data from these studies will be contributed to the cohort phase of Heartshare.
We will make robust contributions to Heartshare by achieving 4 specific aims:
Aim 1) Provide 'thought leadership' in collaboration with the Heartshare Steering Committee;
Aim 2) Contribute data, images, and stored specimens cohort phase of Heartshare from our numerous studies of HFPEF and controls, and identify and phenotype HFPEF patients and controls from the electronic health record using robust bioinformatics tools;
Aim 3) Recruit, consent, enroll and follow at least 250 HFPEF patients plus controls (type and number to be determined by consensus);
Aim 4) Conduct state-of-the-art deep phenotyping exams using a collaboratively determined protocol.
Our phenotyping proposal is highly innovative, with advanced echo-Doppler and cardiac magnetic resonance imaging, CPET, physical activity monitoring, remote and artificial intelligence electrocardiography, sampling of skeletal muscle, adipose, blood, and microbiome, and mitochondrial energetics, and brain structure/function.
Our diverse, cross-disciplinary team has the full range of complementary expertise and access to the robust resources of two large, closely affiliated health systems to ensure fulfillment of all Heartshare's goals. We will help accelerate and optimize the program's success with our insight, creativity, and sustained track record of collaboration, innovation, and dissemination.
Funding Goals
TO FOSTER HEART AND VASCULAR RESEARCH IN THE BASIC, TRANSLATIONAL, CLINICAL AND POPULATION SCIENCES, AND TO FOSTER TRAINING TO BUILD TALENTED YOUNG INVESTIGATORS IN THESE AREAS, FUNDED THROUGH COMPETITIVE RESEARCH TRAINING GRANTS. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM: TO STIMULATE TECHNOLOGICAL INNOVATION, USE SMALL BUSINESS TO MEET FEDERAL RESEARCH AND DEVELOPMENT NEEDS, FOSTER AND ENCOURAGE PARTICIPATION IN INNOVATION AND ENTREPRENEURSHIP BY SOCIALLY AND ECONOMICALLY DISADVANTAGED PERSONS, AND INCREASE PRIVATE-SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT FUNDING. SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM: TO STIMULATE TECHNOLOGICAL INNOVATION, FOSTER TECHNOLOGY TRANSFER THROUGH COOPERATIVE R&D BETWEEN SMALL BUSINESSES AND RESEARCH INSTITUTIONS, AND INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL R&D.
Grant Program (CFDA)
Awarding / Funding Agency
Place of Performance
Winston Salem,
North Carolina
27157
United States
Geographic Scope
Single Zip Code
Related Opportunity
Analysis Notes
Amendment Since initial award the total obligations have increased 592% from $274,703 to $1,901,283.
Wake Forest University Health Sciences was awarded
Wake Forest Atrium HeartShare Clinical Center
Cooperative Agreement U01HL160272
worth $1,901,283
from National Heart Lung and Blood Institute in September 2021 with work to be completed primarily in Winston Salem North Carolina United States.
The grant
has a duration of 4 years 10 months and
was awarded through assistance program 93.837 Cardiovascular Diseases Research.
The Cooperative Agreement was awarded through grant opportunity HeartShare: Next-Generation Phenomics to Define Heart Failure Subtypes (U01 Clinical Trial Not Allowed).
Status
(Ongoing)
Last Modified 7/21/25
Period of Performance
9/10/21
Start Date
7/31/26
End Date
Funding Split
$1.9M
Federal Obligation
$0.0
Non-Federal Obligation
$1.9M
Total Obligated
Activity Timeline
Transaction History
Modifications to U01HL160272
Additional Detail
Award ID FAIN
U01HL160272
SAI Number
U01HL160272-4242280523
Award ID URI
SAI UNAVAILABLE
Awardee Classifications
Private Institution Of Higher Education
Awarding Office
75NH00 NIH National Heart, Lung, and Blood Institute
Funding Office
75NH00 NIH National Heart, Lung, and Blood Institute
Awardee UEI
SN7KD2UK7GC5
Awardee CAGE
1WEZ6
Performance District
NC-10
Senators
Thom Tillis
Ted Budd
Ted Budd
Budget Funding
| Federal Account | Budget Subfunction | Object Class | Total | Percentage |
|---|---|---|---|---|
| National Heart, Lung, and Blood Institute, National Institutes of Health, Health and Human Services (075-0872) | Health research and training | Grants, subsidies, and contributions (41.0) | $549,401 | 100% |
Modified: 7/21/25