Notice of Special Interest (NOSI): Administrative Supplements to Encourage Research in Valvular Heart Disease (CAROL Act)
Notice Number:
NOT-HL-23-078

Key Dates

Release Date:

March 15, 2023

First Available Due Date:
June 01, 2023
Expiration Date:
June 02, 2026

Related Announcements

NOT-HL-23-085 - NHLBI Notice of Availability of Frequently Asked Questions (FAQs) for NOT-HL-23-078 and NOT-HL-23-079 (CAROL Act).

PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

PA-21-071 - Research Supplements to Promote Diversity in Health-Related Research (Admin Supp - Clinical Trial Not Allowed)

Issued by

National Heart, Lung, and Blood Institute (NHLBI)

Purpose

As part of the National Heart, Lung, and Blood Institute’s implementation of the Cardiovascular Advances in Research and Opportunities Legacy (CAROL) Act, this Notice of Special Interest seeks applications for administrative supplements to existing NIH grants and cooperative agreements that propose research in valvular heart disease (VHD). As administrative supplements, the proposed work must be within the scope of the parent award.

Selected Research Examples

The CAROL Act explicitly encourages research using advanced imaging techniques and research on risk factors for sudden cardiac arrest or sudden cardiac death from valvular heart disease, most commonly associated with mitral valve prolapse (MVP). However, the Act also encourages research on valvular heart disease more broadly. Selected research examples may include, but are not limited to:

  • Registry activities. Collection of de-identified clinical data (e.g., imaging, omics, electrophysiology, therapy, outcomes, electronic health record data) on individuals with MVP from diverse populations.
  • Data science. Development of artificial intelligence or machine learning techniques for comprehensive risk assessment and improved phenotypic characterization of individuals with MVP. Development of approaches to enhance diagnostic imaging of individuals with MVP.
  • Basic. Studies of the mechanisms of fibrosis, inflammation, and ventricular arrhythmia in MVP and of persistent left ventricular dysfunction after mitral valve intervention. Development of relevant animal models and computational models.
  • Clinical. Comparing mitral valve intervention to watchful waiting in asymptomatic individuals with MVP. Studies to establish ideal intervals for imaging and electrophysiological monitoring and to identify key determinants of outcomes.
  • Omics. Genomic studies that span the clinical heterogeneity of MVP using multiplex and high-throughput methods. Development of polygenic risk scores for MVP and sudden cardiac death. Development of a molecular atlas of valvular heart disease. Studies that use established NHLBI resources with large-scale human data sets (TOPMed, BioData Catalyst, existing HLBS cohorts).
  • Implementation. Studies that address the observed disparities across diverse communities and the spectrum of socioeconomic status in diagnosis, management, treatment, and referral of individuals with MVP. Studies of patient preferences for therapy and follow-up.

These and other research examples are detailed in the report of the NHLBI Workshop on Research in the Treatment of Mitral Valve Prolapse, November 30 December 2, 2021.

Administrative supplement requests that propose research on other anatomic valves (e.g., lymphatic valves, venous valves) will not be considered in response to this Notice and will not be reviewed.

Eligibility

To be eligible, the parent award must be an active NIH grant or cooperative agreement. The parent award must have at least one year remaining in its original project period at the time that the administrative supplement is awarded. Parent awards in a terminal no-cost extension are not eligible.

Application and Submission Information

Applications for this initiative must be submitted using one of the following Notices of Funding Opportunity (NOFOs, formerly called Funding Opportunity Announcements or FOAs) or their subsequent reissued equivalents:

  • PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

    All instructions in the SF424 (R&R) Application Guide and PA-20-272 must be followed, with the following additions:

    • Application Due Date(s) - Applications will be accepted at any time, but applications should be received by the NIH by June 1, 5:00 PM local time of applicant organization, for award during that federal fiscal year.
    • For funding consideration, applicants must include NOT-HL-23-078 (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 (R&R) form. Applications without this information in box 4B will not be considered for this initiative.
    • The request may be for no more than one year of support.
    • Applicants must have sufficient time remaining to complete the proposed project within the current approved project period of the parent award.
    • The Research Strategy section of the application is limited to 6 pages.
    • Only one administrative supplement request in response to PA-20-272 will be considered for each parent application.
    • Applicants are strongly encouraged to notify the program contact at the institute supporting the parent award that a request has been submitted in response to this Notice of Special Interest in order to facilitate efficient processing of the request.
  • PA-21-071 - Research Supplements to Promote Diversity in Health-Related Research (Admin Supp - Clinical Trial Not Allowed)

    All instructions in the SF424 (R&R) Application Guide, PA-21-071, and the NHLBI Research Supplement Application Guidelines must be followed, with the following additions:

    • For funding consideration, applicants must include NOT-HL-23-078 (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 (R&R) form. Applications without this information in box 4B will not be considered for this initiative.
    • Applicants are strongly encouraged to notify the program contact at the institute supporting the parent award that a request has been submitted in response to this Notice of Special Interest in order to facilitate efficient processing of the request.

Inquiries

Please direct all inquiries related to this NOSI to the following contacts:

Frank Evans, PhD
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-402-2647
Email: [email protected]