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 within the National Institutes of Health under the U.S. Department of Health and Human Services. This opportunity represents a continuation of the HeartShare program, a large-scale phenomics initiative focused on heart failure with preserved ejection fraction. The program builds upon HeartShare 1.0 and aims to further refine disease subtypes, identify biomarkers, and support precision clinical trials through coordinated data infrastructure and analysis. The primary purpose of this funding opportunity is to support a Data Translation Center that will oversee the coordination, integration, and analysis of complex datasets derived from both retrospective and prospective studies. The center is expected to manage deep phenotyping efforts, including clinical, imaging, and multi-omics data, while facilitating data sharing through platforms such as the NHLBI BioData Catalyst. The funded entity will also support the design and implementation of future clinical trials by providing statistical, informatics, and operational expertise across multiple collaborating centers. Funding supports a wide range of activities including administrative coordination, data portal development, data management, biostatistics, and advanced analytics. Allowable costs include personnel, data infrastructure, clinical coordination, biospecimen management, and research training components. The award structure allows for varying annual direct costs over a six-year project period, with higher funding in earlier years and tapering support in later years. There is no cost-sharing requirement specified, and funds are distributed under a cooperative agreement mechanism, indicating substantial involvement from NIH program staff. Eligibility for this opportunity is highly restricted, as it is a single source funding announcement intended only for Northwestern University and specifically for investigators associated with a prior HeartShare award. The application must follow NIH multi-component submission requirements, including an Overall component and three required cores: Administrative, Data Portal, and Data Management. Applicants must submit through Grants.gov using NIH systems such as ASSIST and comply with all registration requirements including SAM, eRA Commons, and ORCID. The application process requires strict adherence to NIH guidelines, including detailed research plans, budget justifications, data management and sharing plans, and multiple component-specific narratives. Evaluation criteria include significance, investigator qualifications, innovation, approach, and environment, with additional emphasis on the ability to manage large-scale, multi-site data and clinical trial coordination. Applications will undergo peer review followed by advisory council review before funding decisions are made. Key dates include an open date of June 9, 2026, and an application due date of July 9, 2026. The earliest anticipated start date is April 2027 following review cycles in late 2026 and early 2027. The program supports a maximum project period of six years. While this specific announcement is not recurring due to its single-source nature, it reflects an ongoing federal investment in cardiovascular research infrastructure and precision medicine initiatives. Contact information is provided via NHLBI program and grants management offices, with email contacts available for scientific and administrative inquiries.

Focus on demonstrating ability to manage large multi site datasets and coordinate clinical trials; emphasize data integration and sharing; align with precision medicine goals; show strong prior experience with consortium scale research