Value AD
CAN BE
ALTERNATIVE
INVESTMENT
Phased Multi-Site Clinical Trial: Testing Prevention of Cardiovascular Disease in Young Adults With High Lifetime Risk Using Surrogate Outcomes - Clinical Coordinating Center (Collaborative U
RFA-HL-25-010
National Institutes of Health
Funding Opportunity Number: RFA-HL-25-010
Opportunity Category: Discretionary
CFDA Number(s): 93.837 -- Cardiovascular Diseases Research
Cost Sharing or Matching Requirement: No
Posted Date: Jul 10, 2024 12:00:00 AM EDT
Closing Date: Oct 28, 2024 12:00:00 AM EDT
Award Ceiling: none
Award Floor: none
Eligible Applicants: Private institutions of higher education,City or township governments,Native American tribal governments (Federally recognized),Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education,For profit organizations other than small businesses,Special district governments,Public housing authorities/Indian housing authorities,Others (see text field entitled "Additional Information on Eligibility" for clarification),State governments,County governments,Native American tribal organizations (other than Federally recognized tribal governments),Public and State controlled institutions of higher education,Small businesses,Independent school districts,Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
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.
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.
Grantor Contact Information: NIH Grants Information grantsinfo@nih.gov
