Single Source: HeartShare 2.0: Refining Heart Failure Subtypes and Treatment Targets for Personalized Clinical Trials - Data Translation Center (U54 Clinical Trial Optional)

The funding opportunity titled Single Source: HeartShare 2.0: Refining Heart Failure Subtypes and Treatment Targets for Personalized Clinical Trials - Data Translation Center is issued by the National Heart, Lung, and Blood Institute, a component of the National Institutes of Health within the U.S. Department of Health and Human Services. The NHLBI supports research across cardiovascular, pulmonary, blood, and sleep disorders, with a focus on advancing scientific discovery and translating findings into improved clinical care. This specific opportunity is structured as a cooperative agreement and is intended as a continuation of an existing large-scale research initiative known as HeartShare, which focuses on understanding heart failure with preserved ejection fraction. The purpose of this funding opportunity is to renew and support the Data Translation Center responsible for coordinating and managing the HeartShare program. The initiative aims to refine subtypes of heart failure with preserved ejection fraction through deep phenotyping, multi-omics data integration, and longitudinal cohort analysis. The Data Translation Center will oversee enrollment continuation, data curation, and advanced analytics while also supporting the design and execution of future precision clinical trials. This effort is part of a broader collaborative framework involving clinical centers, a clinical trial center, and partnerships with federal agencies, industry, and nonprofit stakeholders. Funding supports a wide range of activities including administrative coordination, data management, informatics infrastructure, biospecimen integration, and statistical analysis. Allowable uses include staffing, infrastructure development, data harmonization, and support for clinical trial planning. The award also includes funds that will be distributed to clinical centers for participant enrollment and phenotyping activities. There is no cost-sharing or matching requirement associated with this opportunity. The project period may extend up to six years, with decreasing direct cost caps over time based on project needs. Eligibility for this opportunity is highly restricted. It is a single source funding announcement that invites only Northwestern University to apply, specifically the principal investigators associated with the prior HeartShare award. The program is not open to other institutions, foreign organizations, or new applicants. The applicant must demonstrate extensive experience in managing complex, multi-site clinical research programs and possess expertise in bioinformatics, data science, and large-scale data integration. Applications must be submitted electronically through Grants.gov using NIH-approved systems such as ASSIST or institutional system-to-system solutions. Applicants are required to follow detailed multi-component application instructions, including submission of separate sections for the overall project, administrative core, data portal core, and data management core. Required components include research strategy, data management and sharing plans, human subjects protections, and resource sharing plans. Compliance with NIH application guidelines is strictly enforced, and noncompliant applications may be rejected. Applications will be evaluated through NIH’s peer review process based on criteria including significance, investigator qualifications, innovation, approach, and environment. Additional considerations include the ability to manage large datasets, coordinate across multiple centers, and support future clinical trials. The timeline includes an application opening date in June, a submission deadline in July, peer review in November, advisory council review in January, and an anticipated project start in April of the following year. Key dates for this opportunity include an open date of June 9, 2026, and an application due date of July 9, 2026. Applications must be submitted by 5:00 PM local time of the applicant organization. The opportunity expires shortly after the deadline, and no recurring cycle is indicated. For questions, applicants may contact the NHLBI HeartShare team via email. The structured governance includes oversight by steering committees, advisory boards, and NIH program staff, ensuring strong coordination and accountability throughout the project lifecycle.

Emphasize strong multi-site coordination experience, robust data management plans, and clear clinical trial readiness aligned with NHLBI priorities