HeartShare 2.0: Refining Heart Failure Subtypes and Treatment Targets for Personalized Clinical Trials - Clinical Trial Center and Clinical Centers (U01 Clinical Trial Optional)
About
The purpose of this Notice of Funding Opportunity (NOFO) is to solicit applications for a new Clinical Trial Center (CTC) and up to seven Clinical Centers (CCs) for the HeartShare 2.0 program. The CTC will coordinate precision clinical trial activities focused on heart failure with preserved ejection fraction (HFpEF), including master protocol development, project management, recruitment oversight, performance milestones, and scientific conduct of trials. The CCs will recruit and retain heart failure patients and controls. The CCs will participate in all aspects of conducting a deep phenotyping protocol and longitudinal follow-up of HFpEF patients; obtaining tissue biopsies; and recruiting patients for future clinical trials. Eligible applicants may submit proposals for either the CTC or CC, but must have different PIs. Each application should include CTC or CC as part of their project title. Companion NOFO for RFA-HL-27-009 will support a Data Translation Center (DTC) for overall coordination of the HeartShare program.
HeartShare 2.0 is a National Institutes of Health (NIH) funding opportunity designed for research institutions and medical centers conducting precision clinical trials in heart failure research. This program seeks to establish a Clinical Trial Center (CTC) and up to seven Clinical Centers (CCs) focused on refining heart failure with preserved ejection fraction (HFpEF) subtypes and identifying personalized treatment targets. The CTC will serve as the coordination hub, overseeing master protocol development, project management, recruitment strategies, performance tracking, and scientific trial conduct. Clinical Centers will focus on recruiting and retaining heart failure patients and controls, conducting deep phenotyping protocols, performing longitudinal follow-up studies, obtaining tissue biopsies, and preparing patient cohorts for future clinical trials. This is an ideal opportunity for academic medical centers, hospital systems, and research institutions with expertise in cardiology, clinical trial management, and patient recruitment. Organizations should have the infrastructure to support complex multi-site coordination or robust patient recruitment capabilities. The program represents a significant investment in precision medicine approaches to heart failure treatment, making it attractive to institutions committed to advancing cardiovascular research and personalized clinical care.
Funding Facts
● Applications openDeadline
July 9, 2026
Award Amount
Up to $500K
Who can apply
Last verified July 5, 2026 · Source: Grants.gov
Grant Details
Grant Amount
Up to $500K
Deadline
2026-07-09
Grant Type
federal
Application Cycle
Annual - Deadline July 9, 2026
Best For
Academic medical centers, hospital systems, and research institutions with cardiology expertise and capacity for clinical trial coordination or patient recruitment
Eligibility
Refer to Section III. Eligibility Information in the NOFO for additional information on eligibility.Foreign Organizations/International Collaborations:Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Frequently Asked Questions
Who is eligible for HeartShare 2.0: Refining Heart Failure Subtypes and Treatment Targets for Personalized Clinical Trials - Clinical Trial Center and Clinical Centers (U01 Clinical Trial Optional)?
Eligible applicants include U.S.-based organizations capable of serving as either a Clinical Trial Center or Clinical Center. Applicants must have different Principal Investigators (PIs) for CTC and CC proposals. Non-domestic (non-U.S.) entities are not eligible; however, non-domestic components of U.S. organizations and foreign components as defined in the NIH Grants Policy Statement are allowed. For complete eligibility requirements, refer to Section III of the official Notice of Funding Opportunity (NOFO) or contact the NIH directly.
How much funding does HeartShare 2.0: Refining Heart Failure Subtypes and Treatment Targets for Personalized Clinical Trials - Clinical Trial Center and Clinical Centers (U01 Clinical Trial Optional) provide?
Funding amounts range from N/A to $500,000 depending on the specific project scope and center type. The exact budget will vary based on whether you are applying as a Clinical Trial Center or Clinical Center, and the specific research activities proposed. Consult the official NOFO for detailed budget guidance and contact the NIH program officer for clarification on funding levels for your specific application type.
How do I apply for HeartShare 2.0: Refining Heart Failure Subtypes and Treatment Targets for Personalized Clinical Trials - Clinical Trial Center and Clinical Centers (U01 Clinical Trial Optional)?
Applications should be submitted through the standard NIH application process, typically via Grants.gov or eRA Commons. Your project title must clearly indicate whether you are applying for the Clinical Trial Center (CTC) or Clinical Centers (CC) role. The application deadline is July 9, 2026. Visit the official NIH NOFO page and Grants.gov website for detailed submission instructions, required forms, and technical assistance. The companion NOFO (RFA-HL-27-009) supports a Data Translation Center for overall program coordination.
What can HeartShare 2.0: Refining Heart Failure Subtypes and Treatment Targets for Personalized Clinical Trials - Clinical Trial Center and Clinical Centers (U01 Clinical Trial Optional) funding be used for?
For the Clinical Trial Center: Master protocol development, coordination of precision clinical trial activities, project management, recruitment oversight, performance milestone tracking, and scientific conduct of trials focused on heart failure with preserved ejection fraction (HFpEF). For Clinical Centers: Patient recruitment and retention, deep phenotyping protocol implementation, longitudinal follow-up studies of HFpEF patients, tissue biopsy collection, and preparing patient cohorts for future clinical trials. All activities should support the overall goal of refining HFpEF subtypes and identifying personalized treatment targets.
Last updated: July 5, 2026