Opportunity Information: Apply for RFA HL 27 008
HeartShare 2.0 is an NIH funding opportunity (RFA-HL-27-008) that aims to move heart failure with preserved ejection fraction (HFpEF) toward more personalized, precision-style clinical trials. The program is built around the idea that HFpEF is not one single disease, but a collection of different subtypes that likely have different biology and may respond to different therapies. This NOFO is specifically seeking applications to stand up the clinical infrastructure that can rigorously define those subtypes, identify actionable treatment targets, and then efficiently test therapies in well-matched patient groups using coordinated, high-quality trial operations.
The solicitation will fund one Clinical Trial Center (CTC) and up to seven Clinical Centers (CCs) under a U01 cooperative agreement mechanism (clinical trial optional). As a cooperative agreement, awardees should expect substantial NIH involvement in the project, with NIH program staff playing an active role in oversight, coordination, and milestone-driven progress rather than functioning purely as a passive funder. The anticipated total set of awards is eight (one CTC plus up to seven CCs), with an award ceiling listed as $500,000.
The Clinical Trial Center is the operational hub for the precision clinical trial activities in HeartShare 2.0. Its responsibilities include developing and maintaining a master protocol (so multiple studies can be run efficiently under a unified framework), managing the overall project, overseeing and harmonizing recruitment across the network, defining and tracking performance milestones, and ensuring the scientific integrity and consistent conduct of trials. In practical terms, the CTC is expected to standardize how trials are planned and executed across all participating sites, reduce duplication, and keep studies aligned with the program goal of matching therapies to HFpEF subtypes.
The Clinical Centers are the patient-facing engines of the network. Each CC is expected to recruit and retain heart failure participants and appropriate control participants, and to carry out deep phenotyping and longitudinal follow-up in HFpEF. Deep phenotyping here implies comprehensive, standardized characterization of participants using detailed clinical assessments and biospecimen-based measures, with an emphasis on generating high-resolution data that can support subtype discovery and validation. A notable component is that CCs are expected to obtain tissue biopsies as part of the protocol, which suggests the program is prioritizing mechanistic insights that cannot be captured from blood tests or imaging alone. Beyond data and sample collection, CCs are also expected to build and maintain a pipeline of well-characterized participants who can be efficiently enrolled into future HeartShare clinical trials.
Applicants can apply to be either the CTC or a CC, but there is an important leadership rule: proposals for the CTC and CCs must have different principal investigators (PIs). In addition, the application title must clearly indicate whether the submission is for the CTC or for a CC (that designation needs to be included as part of the project title). This helps NIH distinguish which role each applicant is proposing to play and ensures the program has a clean governance structure with distinct leadership responsibilities across the network.
HeartShare 2.0 also includes a companion funding opportunity (RFA-HL-27-009) that will support a Data Translation Center (DTC). While this particular NOFO does not fund the DTC, the DTC is described as providing overall coordination for the broader HeartShare program, implying that awardees under RFA-HL-27-008 will need to work closely with the DTC for data harmonization, data management workflows, and cross-site integration so that phenotyping and trial data can be rapidly translated into usable knowledge and trial-ready insights.
Eligibility is broad and includes many common U.S.-based applicant types: federal recognized tribal governments and organizations, state and local governments, public and private institutions of higher education, nonprofits (both 501(c)(3) and non-501(c)(3)), for-profit organizations (including entities other than small businesses), and small businesses. International participation is limited in a typical NIH way for a network meant to be run from the U.S.: non-U.S. organizations cannot apply as the primary applicant, but non-U.S. components of U.S. organizations may be included, and foreign components (as defined in NIH policy) are allowed. That structure leaves room for targeted international collaboration or specialized capabilities while keeping the leadership, award, and primary accountability within eligible U.S. institutions.
From an administrative standpoint, the opportunity is categorized as discretionary funding and uses the cooperative agreement funding instrument. It is listed under the NIH with CFDA number 93.837. The original closing date is July 9, 2026, and the NOFO creation date is May 19, 2026. Overall, the opportunity is designed to create a coordinated, milestone-driven clinical research network that can (1) deeply characterize HFpEF patients, (2) refine biologically meaningful subtypes, and (3) translate those insights into efficient, well-run, precision-focused clinical trials.Apply for RFA HL 27 008
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "HeartShare 2.0: Refining Heart Failure Subtypes and Treatment Targets for Personalized Clinical Trials - Clinical Trial Center and Clinical Centers (U01 Clinical Trial Optional)" 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 2026-05-19.
- Applicants must submit their applications by 2026-07-09. (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 $500,000.00 in funding.
- The number of recipients for this funding is limited to 8 candidate(s).
- 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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HeartShare 2.0 (RFA-HL-27-008) FAQ
1) What is HeartShare 2.0 (RFA-HL-27-008)?
HeartShare 2.0 is an NIH funding opportunity designed to build clinical infrastructure that can move heart failure with preserved ejection fraction (HFpEF) toward personalized, precision-style clinical trials. The program is based on the premise that HFpEF is not one single disease, but a collection of subtypes that may have different underlying biology and may respond differently to therapies.
2) What problem is the program trying to solve in HFpEF research?
The opportunity targets the challenge that HFpEF is heterogeneous. Instead of treating HFpEF as one uniform condition, HeartShare 2.0 aims to rigorously define HFpEF subtypes, identify actionable treatment targets for those subtypes, and test therapies efficiently in patient groups that are appropriately matched to the therapy being studied.
3) What does this NOFO fund?
This NOFO funds the clinical network infrastructure needed to support precision clinical trials in HFpEF, including standardized deep phenotyping, longitudinal follow-up, and coordinated trial operations across multiple sites. It will support one Clinical Trial Center (CTC) and up to seven Clinical Centers (CCs).
4) How many total awards are expected under this opportunity?
The anticipated total set of awards is eight: one Clinical Trial Center (CTC) plus up to seven Clinical Centers (CCs).
5) What funding mechanism is used?
The awards are made under a U01 cooperative agreement mechanism (clinical trial optional). As a cooperative agreement, the NIH expects substantial involvement in oversight, coordination, and milestone-driven progress.
6) What does "substantial NIH involvement" mean in this context?
Because this is a cooperative agreement, NIH program staff are expected to play an active role in project oversight and coordination, with progress tied to milestones. The NIH role is described as more engaged than a typical grant where the funder is largely passive after award.
7) What is the award ceiling listed for this opportunity?
The NOFO lists an award ceiling of $500,000.
8) What is the difference between the Clinical Trial Center (CTC) and the Clinical Centers (CCs)?
The CTC serves as the operational hub for the precision clinical trial activities, while the CCs are the patient-facing sites responsible for recruiting and retaining participants and performing standardized deep phenotyping and longitudinal follow-up.
9) What are the main responsibilities of the Clinical Trial Center (CTC)?
The CTC is expected to develop and maintain a master protocol to enable multiple studies under a unified framework, manage the overall project, oversee and harmonize recruitment across the network, define and track performance milestones, and ensure scientific integrity and consistent conduct of trials across participating sites.
10) What is meant by a "master protocol" in HeartShare 2.0?
A master protocol is a unified trial framework that allows multiple studies to be planned and run efficiently under standardized methods. In HeartShare 2.0, it is intended to reduce duplication across sites, standardize trial conduct, and keep studies aligned with matching therapies to HFpEF subtypes.
11) What are the main responsibilities of the Clinical Centers (CCs)?
Each CC is expected to recruit and retain HFpEF participants and appropriate control participants, perform deep phenotyping using comprehensive standardized clinical and biospecimen-based measures, and conduct longitudinal follow-up. CCs are also expected to build and maintain a pipeline of well-characterized participants for efficient enrollment into future HeartShare clinical trials.
12) What does "deep phenotyping" mean in this NOFO?
Deep phenotyping refers to comprehensive, standardized characterization of participants using detailed clinical assessments and biospecimen-based measures. The emphasis is on generating high-resolution data suitable for HFpEF subtype discovery and validation.
13) Are tissue biopsies required as part of the Clinical Center work?
Yes. The NOFO describes that CCs are expected to obtain tissue biopsies as part of the protocol, indicating a focus on mechanistic insights that may not be captured by blood tests or imaging alone.
14) Does this NOFO include clinical trials?
The mechanism is described as U01 cooperative agreement with "clinical trial optional." The overall program is intended to enable efficient, precision-focused clinical trials once HFpEF subtypes and actionable targets are defined and trial operations are standardized.
15) Can an applicant apply to be both the CTC and a CC?
The NOFO indicates applicants can apply to be either the CTC or a CC, but includes a leadership rule that proposals for the CTC and CCs must have different principal investigators (PIs). This establishes distinct leadership responsibilities across the network.
16) What is the principal investigator (PI) rule for HeartShare 2.0 applications?
Proposals for the CTC and the CCs must have different PIs. This rule is intended to support clean governance and distinct leadership across the network roles.
17) How should applicants label their applications so NIH can identify the intended role?
The application title must clearly indicate whether the submission is for the Clinical Trial Center (CTC) or for a Clinical Center (CC). The designation must be included as part of the project title.
18) What is the Data Translation Center (DTC), and is it funded by this NOFO?
HeartShare 2.0 includes a companion funding opportunity (RFA-HL-27-009) that will support a Data Translation Center (DTC). This NOFO (RFA-HL-27-008) does not fund the DTC, but awardees under RFA-HL-27-008 are expected to work closely with the DTC for data harmonization, data management workflows, and cross-site integration.
19) How is the DTC expected to interact with awardees under RFA-HL-27-008?
The DTC is described as providing overall coordination for the broader HeartShare program. CTC and CC awardees under this NOFO are expected to coordinate with the DTC to support harmonized and integrated data processes so phenotyping and trial data can be translated into usable knowledge and trial-ready insights.
20) Who is eligible to apply?
Eligibility is broad and includes U.S.-based applicant types such as federally recognized tribal governments and organizations, state and local governments, public and private institutions of higher education, nonprofits (501(c)(3) and non-501(c)(3)), for-profit organizations (including entities other than small businesses), and small businesses.
21) Can non-U.S. organizations apply as the primary applicant?
No. Non-U.S. organizations cannot apply as the primary applicant under this opportunity.
22) Are foreign components allowed at all?
Yes. Non-U.S. components of U.S. organizations may be included, and foreign components (as defined in NIH policy) are allowed. This allows targeted international collaboration or specialized capabilities while keeping the primary award and accountability within eligible U.S. institutions.
23) What agency is offering this funding opportunity?
This is an NIH funding opportunity.
24) What is the CFDA number listed for this opportunity?
The CFDA number listed is 93.837.
25) What type of funding is this categorized as?
The opportunity is categorized as discretionary funding and uses a cooperative agreement funding instrument.
26) What are the key dates provided?
The NOFO creation date is May 19, 2026, and the original closing date is July 9, 2026.
27) What is the overall end-to-end goal of HeartShare 2.0?
The opportunity is designed to create a coordinated, milestone-driven clinical research network that can (1) deeply characterize HFpEF patients, (2) refine biologically meaningful subtypes, and (3) translate those insights into efficient, well-run, precision-focused clinical trials that test therapies in appropriately matched patient groups.
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