The National Heart, Lung, and Blood Institute (NHLBI) is offering this grant to establish a Clinical Coordinating Center. This grant supports a phased, multi-site primary prevention clinical trial focused on young adults under fifty years old who face a high lifetime risk of cardiovascular disease (CVD), despite low or borderline 10-year risk. The trial’s purpose is to identify and test interventions that effectively reduce or slow the progression of subclinical coronary atherosclerosis. It involves two phases: initial screening for eligible participants, followed by evaluating the efficacy of different interventions across three arms—a control group utilizing current behavioral guidelines, a pharmacological intervention arm, and an arm testing interventions with less definitive evidence. The long-term goal is to determine if earlier treatment strategies can prevent more CVD than current guideline-recommended approaches.
Opportunity ID: 355312
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-HL-25-010 |
| Funding Opportunity Title: | Phased Multi-Site Clinical Trial: Testing Prevention of Cardiovascular Disease in Young Adults With High Lifetime Risk Using Surrogate Outcomes – Clinical Coordinating Center (Collaborative UG3/UH3 Clinical Trial Required) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.837 — Cardiovascular Diseases Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Jul 10, 2024 |
| Last Updated Date: | Jul 10, 2024 |
| Original Closing Date for Applications: | Oct 28, 2024 |
| Current Closing Date for Applications: | Oct 28, 2024 |
| Archive Date: | Dec 03, 2024 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education County governments Public and State controlled institutions of higher education For profit organizations other than small businesses Special district governments Others (see text field entitled “Additional Information on Eligibility” for clarification) Independent school districts Small businesses City or township governments Public housing authorities/Indian housing authorities Native American tribal governments (Federally recognized) Private institutions of higher education State governments |
| Additional Information on Eligibility: | Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; 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. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | The goal of this funding opportunity for a Clinical Coordinating Center is to support a clinical trial which will test intervention(s) to reduce the progression of coronary atherosclerosis among young adults under the age of fifty years old who are at low or borderline 10-year risk ( 7.5%) for their first an atherosclerotic cardiovascular disease (ASCVD) event, yet at high lifetime risk of developing cardiovascular disease (CVD). This opportunity will support a two-phased primary prevention clinical trial that will first efficiently screen the appropriate population eligible for the intervention and second determine which intervention(s) are most efficacious at reducing the onset or slowing the progression of subclinical coronary atherosclerosis. It is expected that phase one will overlap with phase two. Trial participants who are identified as meeting the subclinical coronary atherosclerosis criteria for enrollment in the screening stage will be immediately enrolled in stage two even although stage one recruitment will continue until the trial is completely enrolled. It is expected that the trial will have three arms. One will be a control or comparison arm and the second and the third arm will test different interventions than the control arm. The control arm should be current guideline based behavioral interventions. One of the two non-control arms is expected to involvement pharmacological intervention(s) with definite evidence of efficacious for primary prevention in older high risk adults such as LDL- lowering therapy and the other arm may involve intervention(s) with less definite evidence of primary prevention efficacy in older adults The long range goal of this research strategy is to determine if earlier treatment prevents more CVD than current guideline recommended treatment. Applications for both a CCC and a DCC must be submitted on the same application due date for consideration by NHLBI. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/rfa-files/RFA-HL-25-010.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH Grants Information
grantsinfo@nih.gov Email:grantsinfo@nih.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
Folder 355312 Full Announcement-RFA-HL-25-010 -> RFA-HL-25-010-Full-Announcement.pdf
Packages
| Agency Contact Information: | NIH Grants Information grantsinfo@nih.gov Email: grantsinfo@nih.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| FORMS-H | Use for due dates on or after January 25, 2023 | PKG00287299 | Sep 11, 2024 | Oct 28, 2024 | View |
Package 1
Mandatory forms
355312 RR_SF424_5_0-5.0.pdf
355312 PHS398_CoverPageSupplement_5_0-5.0.pdf
355312 RR_OtherProjectInfo_1_4-1.4.pdf
355312 PerformanceSite_4_0-4.0.pdf
355312 RR_KeyPersonExpanded_4_0-4.0.pdf
355312 RR_Budget10_3_0-3.0.pdf
355312 PHS398_ResearchPlan_5_0-5.0.pdf
355312 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
355312 RR_SubawardBudget10_30_3_0-3.0.pdf
355312 PHS_AssignmentRequestForm_3_0-3.0.pdf
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