HeartShare: Next Generation Phenomics to Define Heart Failure Subtypes and Treatment Targets Data Translation Center (U54 Clinical Trial Not Allowed) | RFA HL 21 016

Opportunity Information: Apply for RFA HL 21 016

The HeartShare: Next Generation Phenomics to Define Heart Failure Subtypes and Treatment Targets Data Translation Center (U54 Clinical Trial Not Allowed) funding opportunity (RFA-HL-21-016) is a National Heart, Lung, and Blood Institute (NHLBI) initiative under the National Institutes of Health (NIH) that aims to build a coordinated, large-scale phenomics program focused on heart failure with preserved ejection fraction (HFpEF). The central scientific purpose is to bring together deep phenotypic information, medical imaging, and multi-omics data from HFpEF patients, then analyze these data at scale to better define distinct HFpEF subtypes, clarify underlying biological mechanisms, and identify actionable treatment targets. In practical terms, the program is meant to move the field beyond broad clinical labels toward more precise, mechanism-based groupings of patients that could eventually support targeted therapies and improved outcomes.

This specific FOA solicits applications for a Data Translation Center (DTC), funded as a U54 cooperative agreement, meaning the award is designed for substantial involvement and coordination with NIH/NHLBI program staff rather than functioning like a typical investigator-initiated research grant. The DTC is positioned as the program hub: it is expected to handle overall project coordination across the HeartShare consortium, support and enable the development of a new HFpEF patient cohort (being enrolled and phenotyped through separately funded Clinical Centers), and curate, harmonize, and analyze existing datasets from NIH cohorts and clinical trials that already include relevant HFpEF participants and measurements. The DTC role is therefore both operational and scientific, combining program management, data infrastructure, data governance, and cross-study analytics to translate complex, heterogeneous data streams into interpretable findings and usable research assets.

The HeartShare structure is explicitly multi-component. While this FOA supports the DTC, a companion announcement (RFA-HL-21-015) supports the Clinical Centers that would recruit and characterize participants and generate new data for the program. The DTC is expected to interface tightly with these Clinical Centers, setting common data standards where appropriate, ensuring consistent data flow and documentation, enabling integration of new cohort data with legacy NIH datasets, and facilitating consortium-wide analyses. The “clinical trial not allowed” designation indicates the DTC award itself is not intended to run an interventional clinical trial; instead, it is focused on data coordination, cohort support activities, and advanced analysis of observational and existing trial-derived data to uncover subtypes and targets.

In terms of who can apply, eligibility is broad and includes many types of U.S.-based organizations and governments. Eligible applicants listed include state, county, and city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; other Native American tribal organizations; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; small businesses; and other entities as allowed by NIH. The announcement also highlights additional eligible categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), as well as faith-based or community-based organizations and regional organizations. Foreign institutions (non-U.S. entities) are not eligible to apply as prime applicants, but non-U.S. components of U.S. organizations are eligible, and foreign components are allowed as defined in NIH policy, which typically means specific, justified parts of the work can be performed outside the U.S. under the direction of an eligible U.S. applicant.

Administratively, the opportunity is categorized as discretionary funding and uses the cooperative agreement mechanism (U54) within the health funding activity category (CFDA 93.837). The original closing date provided is January 8, 2021, and the posted award ceiling is $2,445,000. While the notice text included “ExpectedAwards:” without a number, the ceiling indicates the maximum budget level anticipated for a single award under this announcement. The overall framing suggests a consortium-style award where the DTC is expected to provide sustained, high-capacity data and coordination services rather than conduct a narrow, stand-alone research project.

Overall, this FOA is best understood as a call to build and operate the data and analytics backbone for a major NHLBI HFpEF phenomics effort. The DTC is expected to make it possible to combine new cohort data with existing NIH study resources, apply modern integrative analytics across clinical phenotypes, imaging, and omics, and produce refined HFpEF subtyping and therapeutic target hypotheses that can be validated and eventually translated into more personalized approaches to prevention and treatment.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "HeartShare: Next Generation Phenomics to Define Heart Failure Subtypes and Treatment Targets Data Translation Center (U54 Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.837.
• This funding opportunity was created on 2020-09-10.
• Applicants must submit their applications by 2021-01-08. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $2,445,000.00 in funding.
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

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