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

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Grant

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

AI Contract Overview

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The National Heart, Lung, and Blood Institute (NHLBI) plans to issue a Notice of Funding Opportunity (NOFO) to support the HeartShare 2.0 program, which aims to advance precision clinical trials focused on heart failure with preserved ejection fraction (HFpEF). This initiative will establish one Clinical Trial Center (CTC) responsible for coordinating key activities such as master protocol development, project management, recruitment oversight, milestone tracking, and the scientific execution of trials. In addition, up to seven Clinical Centers (CCs) will be funded to recruit and manage HFpEF patients and controls, conduct deep phenotyping and longitudinal follow-up, obtain tissue biopsies, and support the interpretation and translation of study results as well as future clinical trials. Applicants may submit proposals for either the CTC or CC roles, with each application clearly indicating its intended role. A companion funding opportunity will separately support a Data Translation Center to facilitate overall program coordination. At this time, applications are not being accepted; the notice serves to provide prospective applicants adequate time to build collaborations and develop project proposals. The funding mechanism will use the U01 activity code, and it is directed toward investigators with relevant expertise in heart failure clinical trials. This effort is authorized under sections 301 and 405 of the Public Health Service Act and applicable federal regulations. Interested parties are encouraged to begin preparations to respond to the upcoming solicitation, and additional information can be obtained through the NHLBI HeartShare team via the provided contact email.

General Info

NHLBI to fund HeartShare 2.0 for HFpEF trials, supporting one trial center and seven clinical centers.

Agency

Department Of Health And Human Services → National Institutes Of Health

NAICS

541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology) View NAICS

Place of Performance

Not specified

Set-Aside

NONE

Documents

(0)

No documents available

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Timeline

Posted

forecast

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → National Institutes Of Health
Contacts1 person available
OfficeUS
Organization / Agency
Department Of Health And Human Services → National Institutes Of Health
Office AddressUS
Contacts
Division of Cardiovascular Sciences HeartShare Team
contact@example.gov

Full Description

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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.

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.

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