U01HL160278
Cooperative Agreement
Overview
Grant Description
Mass General Brigham HeartShare Clinical Center - Project Summary
Heart failure with preserved ejection fraction (HFPEF) comprises approximately half of all HF and is a highly morbid condition. Pharmacotherapies that are effective in treating HF with reduced ejection fraction have more modest if any beneficial impacts on HFPEF, potentially owing to heterogeneous definitions of HFPEF and limited understanding of optimal pathways to target in HFPEF.
Our team of investigators has extensive experience in HFPEF human subjects research. Complementary dyspnea and heart failure evaluation programs attract referral of HFPEF patients as well as dyspneic control patients without HFPEF to the Massachusetts General Hospital and Brigham and Women's Hospital ("Mass General Brigham, MGB"). In addition, our team is highly engaged in assessing therapeutic interventions for HFPEF through robust clinical trials programs.
The MGB HeartShare team's PIs are responsible for HFPEF clinical trial conceptualization, design, implementation, and endpoint adjudication via established core laboratories in echocardiography, cardiopulmonary exercise testing, advanced cardiovascular imaging, all of which could be used to support HeartShare. Our team also has expertise in working with MGB-based electronic health record data, population study data, and clinical trials that inform our understanding of HFPEF.
Our group has used comprehensive cardiopulmonary exercise testing (CPET) to simultaneously quantitate invasive hemodynamics, blood gases, cardiac function, arterial tonometry and gas exchange patterns during exercise in individuals with conventionally defined HFPEF. We have begun to delineate contributions of impaired cardiac, pulmonary, vascular, and peripheral musculoskeletal reserve capacity that are not evident at rest.
Our single-center HFPEF phenotyping study already consists of >700 patients with HFPEF subjected to uniform phenotyping (echocardiography, NT-proBNP, multi-site blood sampling at rest and with exercise and comprehensive CPET).
In Aim 1, we will assemble a collaborative multidisciplinary investigative team capable of recruiting, phenotyping, and retaining =250 HFPEF patients in the HeartShare program while also drawing from experience with core lab oversight, bioinformatic expertise in electronic medical record research, and leadership of network, population cohort, and clinical trial research relevant to HFPEF.
In Aim 2, we will refine the diagnosis and subclassification of HFPEF through comprehensive clinical assessment including multi-modality imaging of cardiac structure and function, perturbational testing with exercise to probe multi-organ system physiologic reserve and longitudinal remote physiologic monitoring and assessment of frailty and cognition. We will also expand on our experience with creation of omics-based signatures of pathophysiologic states in HFPEF and deploy unsupervised machine learning approaches to the derived data.
HeartShare will enhance understanding of HFPEF and our team is poised to translate improved understanding of HFPEF subtypes into new therapeutic intervention trials in HFPEF.
Heart failure with preserved ejection fraction (HFPEF) comprises approximately half of all HF and is a highly morbid condition. Pharmacotherapies that are effective in treating HF with reduced ejection fraction have more modest if any beneficial impacts on HFPEF, potentially owing to heterogeneous definitions of HFPEF and limited understanding of optimal pathways to target in HFPEF.
Our team of investigators has extensive experience in HFPEF human subjects research. Complementary dyspnea and heart failure evaluation programs attract referral of HFPEF patients as well as dyspneic control patients without HFPEF to the Massachusetts General Hospital and Brigham and Women's Hospital ("Mass General Brigham, MGB"). In addition, our team is highly engaged in assessing therapeutic interventions for HFPEF through robust clinical trials programs.
The MGB HeartShare team's PIs are responsible for HFPEF clinical trial conceptualization, design, implementation, and endpoint adjudication via established core laboratories in echocardiography, cardiopulmonary exercise testing, advanced cardiovascular imaging, all of which could be used to support HeartShare. Our team also has expertise in working with MGB-based electronic health record data, population study data, and clinical trials that inform our understanding of HFPEF.
Our group has used comprehensive cardiopulmonary exercise testing (CPET) to simultaneously quantitate invasive hemodynamics, blood gases, cardiac function, arterial tonometry and gas exchange patterns during exercise in individuals with conventionally defined HFPEF. We have begun to delineate contributions of impaired cardiac, pulmonary, vascular, and peripheral musculoskeletal reserve capacity that are not evident at rest.
Our single-center HFPEF phenotyping study already consists of >700 patients with HFPEF subjected to uniform phenotyping (echocardiography, NT-proBNP, multi-site blood sampling at rest and with exercise and comprehensive CPET).
In Aim 1, we will assemble a collaborative multidisciplinary investigative team capable of recruiting, phenotyping, and retaining =250 HFPEF patients in the HeartShare program while also drawing from experience with core lab oversight, bioinformatic expertise in electronic medical record research, and leadership of network, population cohort, and clinical trial research relevant to HFPEF.
In Aim 2, we will refine the diagnosis and subclassification of HFPEF through comprehensive clinical assessment including multi-modality imaging of cardiac structure and function, perturbational testing with exercise to probe multi-organ system physiologic reserve and longitudinal remote physiologic monitoring and assessment of frailty and cognition. We will also expand on our experience with creation of omics-based signatures of pathophysiologic states in HFPEF and deploy unsupervised machine learning approaches to the derived data.
HeartShare will enhance understanding of HFPEF and our team is poised to translate improved understanding of HFPEF subtypes into new therapeutic intervention trials in HFPEF.
Awardee
Funding Goals
NOT APPLICABLE
Grant Program (CFDA)
Awarding / Funding Agency
Place of Performance
Boston,
Massachusetts
021142621
United States
Geographic Scope
Single Zip Code
Related Opportunity
Analysis Notes
Amendment Since initial award the total obligations have increased 297% from $285,309 to $1,131,905.
The General Hospital Corporation was awarded
Mass General Brigham HeartShare Clinical Center
Cooperative Agreement U01HL160278
worth $1,131,905
from National Heart Lung and Blood Institute in September 2021 with work to be completed primarily in Boston Massachusetts 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 8/5/24
Period of Performance
9/10/21
Start Date
7/31/26
End Date
Funding Split
$1.1M
Federal Obligation
$0.0
Non-Federal Obligation
$1.1M
Total Obligated
Activity Timeline
Subgrant Awards
Disclosed subgrants for U01HL160278
Transaction History
Modifications to U01HL160278
Additional Detail
Award ID FAIN
U01HL160278
SAI Number
U01HL160278-1971622734
Award ID URI
SAI UNAVAILABLE
Awardee Classifications
Nonprofit With 501(c)(3) IRS Status (Other Than An 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
FLJ7DQKLL226
Awardee CAGE
0ULU5
Performance District
MA-08
Senators
Edward Markey
Elizabeth Warren
Elizabeth Warren
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) | $568,483 | 100% |
Modified: 8/5/24