HeartShare: Next-Generation Phenomics to Define Heart Failure Subtypes (U01 Clinical Trial Not Allowed) | RFA HL 21 015

Opportunity Information: Apply for RFA HL 21 015

HeartShare: Next-Generation Phenomics to Define Heart Failure Subtypes and Treatment Targets is a National Heart, Lung, and Blood Institute (NHLBI) funding opportunity that uses a U01 cooperative agreement mechanism to build a coordinated, multi-site phenomics program focused on heart failure with preserved ejection fraction (HFpEF). The central aim is to carry out large-scale, deep phenotyping of people with HFpEF by collecting and analyzing detailed clinical phenotypes, imaging data, and multiple types of omics data. By integrating these data at scale, the program is intended to refine how HFpEF is subdivided into more biologically meaningful subtypes, clarify underlying disease mechanisms, and help surface actionable therapeutic targets. The announcement is explicitly labeled "Clinical Trial Not Allowed," signaling that the supported activities should center on observational phenotyping, data and biospecimen collection, and mechanistic discovery rather than testing interventions in a clinical trial framework.

This particular FOA (RFA-HL-21-015) solicits applications for Clinical Centers (CCs). These Clinical Centers are expected to do the on-the-ground work of recruiting, enrolling, and retaining HFpEF participants as well as appropriate control participants, and to execute a shared, program-wide deep phenotyping protocol. Beyond participant recruitment and protocol execution, Clinical Centers are also expected to be active partners in the broader scientific effort, meaning they contribute to the planning of the phenotyping approach, help ensure data and biospecimen quality, and participate in interpreting findings and translating results into insights that can guide future therapeutic development. In other words, the Clinical Centers are not just enrollment sites; they are meant to be scientifically engaged collaborators in a coordinated network.

HeartShare is designed as a coordinated program with central support for data coordination and translation. A companion funding opportunity (RFA-HL-21-016) supports a Data Translation Center that provides overall coordination for the HeartShare program. While the CC-focused FOA centers on patient-facing recruitment and phenotyping operations, the companion Data Translation Center is positioned to handle program-level coordination activities that typically include harmonization of data and workflows, cross-site standards, and enabling integrated analyses and dissemination pathways. Together, the two FOAs describe a networked structure: Clinical Centers generate high-quality, harmonized phenotypic, imaging, and omics datasets from HFpEF participants and controls, while the centralized component supports coordination and translation of the resulting data resources.

In terms of eligibility, the opportunity is broadly open across many organization types, reflecting NIH norms for cooperative agreements. Eligible applicants include various levels of government (state, county, city/township, special district), independent school districts, public and state-controlled institutions of higher education, private institutions of higher education, nonprofit organizations (with or without 501(c)(3) status), public housing authorities/Indian housing authorities, federally recognized Native American tribal governments, and Native American tribal organizations other than federally recognized tribal governments. For-profit organizations (other than small businesses) and small businesses are also eligible. The FOA also highlights inclusion of institutions and organizations that serve specific populations and communities, 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 (AANAPISISs), along with faith-based or community-based organizations and regional organizations, and it notes eligibility for U.S. territories or possessions.

The geographic and foreign involvement rules are specific: non-domestic (non-U.S.) entities (foreign organizations or foreign institutions) are not eligible to apply as the primary applicant. However, non-domestic components of U.S. organizations are eligible, and foreign components (as defined in the NIH Grants Policy Statement) are allowed. Practically, this means the main awardee organization must be U.S.-based and eligible under NIH rules, but certain project elements can involve foreign components when justified and consistent with NIH policy.

Administratively, the funding opportunity is issued by the National Institutes of Health (NIH) under CFDA number 93.837, categorized as a health-related discretionary program and using a cooperative agreement funding instrument, which generally implies substantial NIH programmatic involvement in shaping and overseeing the coordinated activities of the network. The source information lists an award ceiling of $200,000 and an original closing date of 2021-01-08 (with a creation date of 2020-09-01), which situates the FOA in that application cycle. Overall, the opportunity is best understood as a network-building and discovery-focused effort: assemble well-characterized HFpEF and control cohorts, apply next-generation phenomics combining clinical, imaging, and omics layers, and use the integrated resource to redefine HFpEF subtypes and highlight mechanistic pathways and targets that can later be pursued in subsequent therapeutic development studies.

• 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 (U01 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 2020-09-01.
• 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 $200,000.00 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.

Apply for RFA HL 21 015

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