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 National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH), has announced its intent to publish a Notice of Funding Opportunity under the title HeartShare 2.0: Refining Heart Failure Subtypes and Treatment Targets for Personalized Clinical Trials. This program, using the U01 cooperative agreement mechanism, aims to establish one Clinical Trial Center (CTC) and up to seven Clinical Centers (CCs) to advance precision medicine approaches for patients with heart failure with preserved ejection fraction (HFpEF). This effort builds on previous HeartShare initiatives by creating infrastructure for personalized trials through deep phenotyping and coordinated research. The CTC will serve as the central hub for trial coordination, overseeing the development of a master protocol, managing recruitment, ensuring adherence to milestones, and supporting the scientific integrity of the program. The CTC will be responsible for harmonizing activities across the clinical centers, providing project management, and ensuring that trials are conducted in compliance with federal research standards. Applicants for the CTC are expected to demonstrate strong expertise in clinical trial coordination, infrastructure building, and oversight of multi-site research. The Clinical Centers will serve as the primary sites for patient recruitment and longitudinal study execution. They will enroll heart failure patients and matched control participants, conduct extensive deep phenotyping assessments, collect and analyze tissue biopsies, and support future trial readiness. Each CC must be capable of managing participant recruitment and retention, conducting complex diagnostic and biological procedures, and contributing to collaborative research interpretation. Centers must also have the capacity to contribute to longitudinal follow-up and integration of research findings into translational outcomes. Eligibility for this program is broad and includes state, county, and city governments, public and private higher education institutions, school districts, tribal governments and organizations, nonprofit organizations with or without 501(c)(3) status, public housing authorities, special district governments, for-profit entities including small businesses, and certain additional groups such as faith-based and community-based organizations, regional organizations, eligible federal agencies, U.S. territories, and foreign institutions. Applicants may submit separate proposals for the CTC or CC roles, but each application must clearly identify whether it is intended for the CTC or a CC in the project title. The anticipated posting date for this opportunity is October 15, 2025, with applications due December 15, 2025. Awards are expected to be issued by May 1, 2026, with project start dates beginning July 1, 2026. At this time, no award ceiling, floor, or total program funding levels have been specified. Cost sharing or matching is not required. The estimated number of awards includes one CTC and up to seven CCs, although final determinations will be based on programmatic review and available appropriations. Applications are not currently being accepted as this is a forecasted opportunity. The purpose of the early announcement is to provide potential applicants time to develop partnerships, prepare proposals, and align their research capacity with the program’s objectives. A companion Notice of Funding Opportunity (RFA-HL-26-027) will support a Data Translation Center to provide program-wide coordination and integration. Interested investigators with relevant expertise in cardiovascular clinical research and trial design are encouraged to prepare for the upcoming solicitation. The Division of Cardiovascular Sciences HeartShare Team is the designated point of contact and can be reached by email for further inquiries.