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

<p style="margin-left:0in;">The NHLBI intends to publish a Notice of Funding Opportunity (NOFO) 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. CCs will participate in all aspects of conducting a deep phenotyping protocol and longitudinal follow-up of HFpEF patients; obtaining tissue biopsies; and interpretating and translating results in addition to supporting future clinical trials. Eligible applicants may submit separate proposals for either the CTC or CC. Each application should include CTC or CC as part of their project title. Companion NOFO will support a Data Translation Center (RFA-HL-26-027) for overall coordination of the HeartShare program.</p><p style="margin-left:0in;">Applications are not being solicited at this time. Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. This NOFO will utilize the U01 activity code. Investigators with expertise and insights into this area are encouraged to begin to consider applying for this NOFO. Grant authorities that allow NHLBI to forecast this opportunity are as follows: Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.</p>