HeartShare 2.0: Refining Heart Failure Subtypes and Treatment Targets for Personalized Clinical Trials - Clinical Trial Center and Clinical Centers (U01 Clinical Trial Optional)

The HeartShare 2.0 funding opportunity is issued by the National Institutes of Health through the National Heart, Lung, and Blood Institute. It is part of a broader federal effort to advance cardiovascular research, specifically targeting heart failure with preserved ejection fraction, a growing and complex public health challenge. The program builds on the initial HeartShare 1.0 initiative and aims to refine disease subtypes and develop targeted treatment approaches through coordinated clinical research. This opportunity uses a cooperative agreement mechanism, meaning that the federal agency will have substantial involvement in guiding and collaborating on funded projects. The primary purpose of this funding opportunity is to establish one Clinical Trial Center and up to seven Clinical Centers that will collectively support the HeartShare 2.0 program. The Clinical Trial Center will coordinate precision clinical trial activities, including protocol development, recruitment oversight, and trial management. Clinical Centers will focus on enrolling patients, conducting deep phenotyping, collecting biospecimens, and participating in longitudinal follow-up and future trials. The program emphasizes collaboration among multiple stakeholders, including academic institutions, industry partners, and federal agencies. Funding supports a wide range of research activities related to heart failure, including patient recruitment, clinical examinations, biospecimen collection, imaging, data analysis, and trial coordination. Allowable costs vary depending on whether the applicant is applying as a Clinical Trial Center or Clinical Center, with multi-year funding structures and escalating budgets for the coordinating center. The maximum project period is six years, and funding levels are designed to reflect the scale and complexity of multi-site clinical research infrastructure. Eligibility for this opportunity is broad and includes higher education institutions, nonprofit organizations, for-profit entities, and various levels of government, including tribal and local governments. However, foreign organizations are not eligible to apply directly, although foreign components within U.S. organizations may be permitted. Applicants must meet standard federal registration requirements, including SAM, Grants.gov, and eRA Commons registration, and principal investigators must have ORCID identifiers. Applications must be submitted electronically through approved federal systems such as Grants.gov or NIH ASSIST. Required components include detailed research strategies, organizational plans, budgets, and a clinical experience attachment demonstrating prior work in clinical trials or observational studies. Applications are evaluated through NIH’s peer review process based on criteria such as significance, innovation, rigor, feasibility, and investigator expertise. Additional considerations include participant recruitment strategies and the ability to execute complex clinical trial networks. The timeline for this opportunity includes an application opening date of June 9, 2026, and a submission deadline of July 9, 2026. Applications will undergo scientific review in November 2026, followed by advisory council review in January 2027, with the earliest project start date in April 2027. The funding opportunity expires shortly after the application deadline, and applicants are encouraged to submit early to allow for corrections. This opportunity does not specify recurring cycles, indicating it may be a one-time or reissued announcement. Overall, HeartShare 2.0 represents a significant federal investment in precision medicine for heart failure, aiming to create a coordinated clinical trial infrastructure that accelerates the development of targeted therapies. The program’s collaborative design, emphasis on data sharing, and integration of advanced phenotyping and analytics position it as a major initiative in cardiovascular research.

Emphasize strong clinical trial experience, demonstrate recruitment capacity, and align with precision medicine objectives; ensure compliance with NIH formatting and submission rules