The National Institutes of Health (NIH) is soliciting applications for its Testing Prevention of Cardiovascular Disease in Young Adults With High Lifetime Risk Using Surrogate Outcomes.
Donor Name: National Institutes of Health (NIH)
State: All States
County: All Counties
Type of Grant: Grant
Deadline: 10/28/2024
Size of the Grant: More than $1 million
Grant Duration: 5-10 Years
Details:
The goal of this Notice of Funding Opportunity (NOFO) is to support a clinical trial which will test intervention(s) to reduce the progression of coronary atherosclerosis among young adults who are at low or borderline 10-year risk (<7.5%) for their first atherosclerotic cardiovascular disease (ASCVD) event, yet at high lifetime risk of developing cardiovascular disease (CVD). For the purpose of this NOFO, “young adults” is defined as less than or equal to 50 years for men, and given the lower rate of coronary atherosclerosis before menopause for women compared to men, it may be reasonable to use an expanded inclusion criteria to include women older than age 50.
This opportunity will support a two component prevention clinical trial that will first efficiently screen the appropriate population eligible for the intervention, and second, to determine which intervention(s) are most efficacious at reducing the onset or slowing the progression of subclinical coronary atherosclerosis. Trial participants who are identified as meeting the subclinical coronary atherosclerosis criteria for enrollment in the screening component will be immediately enrolled in the intervention, even though component one recruitment continues until the trial is completely enrolled.
Phases of Award
- Applicants must address objectives for both a two-year UG3 and a five-year UH3 phase and are strongly encouraged to use project management principles, as appropriate. A key characteristic of this NOFO is completion of core milestones. A core milestone is defined as a scheduled event in the project timeline that signifies the completion of a major project stage or activity. Milestones must be performance-based to achieve completion of the trial on time and on budget and must be established for both the UG3 and UH3 phases of the project.
- The magnitude of the number of participants successfully screened and recruited into the trial during the UG3 phase will be an important indicator of the likelihood of continued success during the UH3 phase. Confirmation that the trial will have access to a sufficient sized potential trial population for trial completion with adequate statistical power is also another important indicator.
- Milestones must address timing of overall recruitment/enrollment and retention goals, including accrual goals for women and minorities, young men ? 50 years old, and the age inclusion criteria for women if different from men. It is expected that, if funded, both the CCC and DCC will be responsible for milestone completion but that only one party, the CCC or the DCC, will be responsible for recording the completion of both CCC and DCC milestones through eConnect, an NHLBI platform that facilitates transfer of electronic information to NHLBI.
- For trials using an FDA-regulated product and requiring an IND or IDE application to administer the product to humans, investigators must (1) secure IND authorization or IDE approval and (2) provide documentation of this authorization or approval to NHLBI before a funding decision will be made. Necessary drugs, devices, or other resources must be obtained by the end of the first year of the UG3 award to allow for the successful launch and execution of the proposed clinical trial in the UH3 phase.
- Applications that address contingency plans to proactively confront potential delays or disturbances in meeting the milestones are strongly encouraged. Investigators and NHLBI will review and mutually agree upon the milestones that will be included in the Terms and Conditions of the award, if awarded. Transition to the UH3 phase is predicated on the successful completion of all UG3 core milestones. NHLBI will review and mutually agree upon the core milestones that must be met during the UG3 phase to allow for completion of the screening component and the trial stage during the UH3 phase. The overall planned enrollment and percentage of active clinical sites expected by the end of the UG3 phase will be agreed upon between the grantee organization (or recipient) and the NHLBI prior to an award.
- NHLBI will conduct an administrative review approximately 21 months into the UG3 phase to determine progress toward achievement of milestones included in the Notice of Award. Subject to NHLBI funding availability and scientific priorities, the UH3 award will be made after administrative review with specific attention to the extent to which all agreed-upon milestones have been met.
- Milestones and timelines for the UH3 phase may be revised and finalized at the time of the UG3/UH3 transition. Less than satisfactory progress in the UH3 phase may lead to phasing out the award. If the UH3 is funded, NHLBI will review the progress of the clinical trial on a regular basis. Slower than anticipated progress toward meeting milestones will result in a re-evaluation of the award by NHLBI including whether the objectives of the trial can be met on time and on budget. If milestones have not been satisfactorily met, subsequent funding years may not be approved and may lead to the phasing out of the award.
Funding Information
The NHLBI intends to commit total costs of up to $3,889,424 in Fiscal Year (FY) 2025; up to $7,003,920 in FY 2026; up to $5,935,160 in FY 2027; up to $5,933,312 year in FY 2028; up to $4,580,576 in FY 2029; up to $4,583,040 in FY 2030; and up to $2,768,304 in FY 2031.
Project Period
The maximum period of the combined UG3 and UH3 phases is 7 years, with up to 2 years for the UG3 phase, and up to 5 years for the UH3 phase.
Eligibility Criteria
Higher Education Institutions
- Public/State Controlled Institutions of Higher Education
- Private Institutions of Higher Education
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
- Hispanic-serving Institutions
- Historically Black Colleges and Universities (HBCUs)
- Tribally Controlled Colleges and Universities (TCCUs)
- Alaska Native and Native Hawaiian Serving Institutions
- Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
Nonprofits Other Than Institutions of Higher Education
- Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
- Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
For-Profit Organizations
- Small Businesses
- For-Profit Organizations (Other than Small Businesses)
Local Governments
- State Governments
- County Governments
- City or Township Governments
- Special District Governments
- Indian/Native American Tribal Governments (Federally Recognized)
- Indian/Native American Tribal Governments (Other than Federally Recognized)
Federal Governments
- Eligible Agencies of the Federal Government
- U.S. Territory or Possession
Other
- Independent School Districts
- Public Housing Authorities/Indian Housing Authorities
- Native American Tribal Organizations (other than Federally recognized tribal governments)
- Faith-based or Community-based Organizations
- Regional Organizations
Foreign Organizations
- Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.
- Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
- Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
For more information, visit Grants.gov.
