Identifying Predictors of Cardiovascular Risk Reduction Among Individuals with Obesity and Cardiovascular Disease on GLP-1 Medications 

Glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide receptor agonists (GLP-1/GIP agonists) are novel drugs for the treatment of diabetes and obesity. A growing body of evidence suggests that these drugs may also have favorable effects on cardiovascular disease (CVD) outcomes. While the GLP-1/GIP agonists offer promise for both the primary and secondary prevention of CVD, the potential for achieving clinically meaningful weight loss appears to vary by demographic, clinical, and healthcare factors. Understanding whether there is similar variation in cardiovascular risk response to the drugs will be crucial for pinpointing population heterogeneity in their impact. 

We invite proposals for a research project focused on identifying predictors of cardiovascular risk reduction among individuals with obesity who are using GLP-1 receptor agonist medications, such as semaglutide and tirzepatide. Proposals are encouraged to leverage data sources including de-identified claims data, electronic health records and prospective cohort studies. 
 
At the American Heart Association, equity and science are at the center of everything we do.  We encourage applications that are focused on underrepresented populations. 

A successful application will address one or more of the following:

1. Examine GLP-1/GIP agonist uptake and use patterns in individuals living with CVD and how patterns of use vary across population subgroups disproportionately affected by obesity. 
2. Develop causal inference approaches to identify the association of GLP-1/GIP agonists with cardiovascular risk reduction in diverse populations. 
3. Identify heterogeneity in the effects of GLP-1/GIP agonists on cardiovascular outcomes according to demographic, clinical, and healthcare factors using causal inference and/or machine learning methods. 
4. Develop modeling approaches to project the future burden of CVD and related disparities considering various scenarios of scale-up of GLP-1/GIP agonists in diverse populations. 

The purpose of this Request for Proposal (RFP) announcement is to fund research focused on the potential contribution of GLP-1/GIP agonists to reducing the CVD burden and disparities in the coming years.

The AHA will fund up to three awards. Each award will be $150,000 (including 10% indirect costs) for one year.

• An additional Amazon Web Services (AWS) service credit (up to $30,000) for use of the American Heart Association Precision Medicine Platform may be provided for computational time, use of AWS tools and infrastructure, and storage. Credit amount will be determined based on estimated need over duration of the grant.

Who we’re looking for:
Proposals are welcomed from researchers with experience in causal inference methods, machine learning, and cardiovascular research. Collaborative proposals involving multidisciplinary teams are encouraged.

• The project lead at each site must be an American Heart Association professional member.
  
  • Join or renew when preparing an application in Proposal Central, online or by phone at 1-888-242-2453 or 972-349-5803.
  • Membership/Partnership processing takes 3 to 5 days; do not wait until the application deadline to renew or join.
• Projects can include collaborators from multiple areas of expertise; however, the project proposal must be submitted by a project lead representing an academic or non-profit organization based in the United States.
• Preference will be given to applicant organizations that are institutes of higher education, public entities, or nonprofits that are tax-exempt under Section 501(c)(3) of the Internal Revenue Code and are not private foundations or Type III supporting organizations. Other types of nonprofit and for-profit organizations are also eligible to apply. The American Heart Association may require additional documentation.
• Organizations that are currently funded through other American Heart Association funding mechanisms can apply.
• Organizations can submit multiple proposals.

Letters of Intent are mandatory and are due Nov 15, 2024, at 3 pm CT via ProposalCentral. 

All Letters of Intent will be reviewed. Those responsive to the RFP will be invited to submit a full application. 

Your letter of intent (2 page limit) should include the following information about the proposed project:

• Project title 
• Name and contact of project lead
• Names, titles, affiliations, relevant expertise of co-investigators
• Names of any collaborating organizations
• Data to be used, statistical plan and power calculations
• Approximate budget for the study
• Planned approach and activities to achieve the goals

Applications must be submitted using ProposalCentral, the American Heart Association’s online submission portal.  The online application requires you to provide information and answer questions beyond what is captured in this document. Deadline is Friday, January 17, 2025 at 3 pm CT. 

Only invited Applicants may submit a full proposal. Applications invited to submit a proposal are chosen from the Letters of Intent. See Details and requirements section below for additional guidance. 

A review will take place with a diverse group of experts.  Committee members will include data scientists and public health experts. 

1. Research plan can be up to 6 pages (12-point font, single space, 1-inch margins on all sides)

• Specific Aims (1 page)
• Research and Methods and Operational plan to achieve the aims (3-4 pages).
• Expected outcomes and deliverables, potential limitations, a timeline, and project success milestones. (1-2 pages)

2. Works Cited (pages for Works Cited are not included in 6-page limitation) (1 page)

3. Budget information including:

a. Salary and fringe benefits of the project lead, mentor, collaborating investigators, and other participating research staff or faculty.
b. Project-related expenses including access to data from a third party, travel, and publication costs in accordance with institutional and American Heart Association policies. Please note that the American Heart Association does not fund the costs of program implementation or operations beyond what is established in an approved budget.
c. Maximum of 10% institutional indirect costs may be claimed on the award.

Duration
Up to 1 year of funding from date of funding, contingent upon milestones and timelines being met.

Number of Awards
The American Heart Association anticipates awarding up to 3 grants, $150,000 per award.
The American Heart Association reserves the right to determine the final number of awardees.

Precision Medicine Platform, research environment, trial workspace

Each team may be eligible to receive Amazon Web Services computational credits to cover the cost of cloud computing for a secure and private workspace on the American Heart Association’s Precision Medicine Platform to enable investigators in each team to collaborate and analyze data securely.

Data analysis is enabled in secure workspaces by a web interface that allows researchers to code in various languages, including R and Python, and to use statistical software including but not limited to SAS and R studio. The most up-to-date machine learning and artificial intelligence software available from Amazon Web Services is also included. Researchers are also able to install their own tools.

The American Heart Association asks that the grantees also accelerate collaboration through the sharing of data and code as well as the coordination for interoperability of data to facilitate findability and sustainability. The American Heart Association fully supports the FAIR (Findable, Accessible, Interoperable and Reusable) guiding principles of data stewardship.

The Platform is HIPAA compliant. Learn more about the Platform’s Security Information.

To learn more about the Precision Medicine Platform:

• Overview
• Full list of available analytical tools
• Videos:
  • Learn more about the platform – video 1
  • Explore the capabilities of the platform – video 2

1. Register here for a 60-day complimentary trial workspace to use during the application period.
2. Once registered, login and go to the Data page and click Request Workspace (do not select any datasets).
3. Within the form, please include the following text for your Researcher Purpose:
   GLP-1 RFP

Final progress report
Awardees must submit a final progress report.  Progress reports may take the form of a required written report in addition to video conferencing, phone calls, and/or face-to-face visits. Reporting will be focused on achievement of stated milestones as indicated in the project timeline. The American Heart Association reserves the right to request additional updates, site visits, or reporting.

Public access
The American Heart Association’s public access policy requires that all journal articles resulting from American Heart Association funding be made freely available in PubMed Central and attributed to a specific American Heart Association award within 12 months of publication. It is the responsibility of the awardee to ensure journal articles are deposited into PubMed Central

Open Data
Any factual data that is needed for independent verification of research results must be made publicly available in the AHA Precision Medicine Platform within 12 months of the end of the funding period (and any no-cost extension). 

Additional Requirements

• The projects submitted can have no scientific or budgetary overlap with other work funded by the AHA or any other source.
• Any inventions, intellectual property, and patents resulting from this funding are governed by the AHA’s Patent, Intellectual Property and Technology Transfer Policy.
• The applicant/awardee and institution are responsible for compliance with all AHA research award policies and guidelines for the duration of any awards they may receive.
• Visit the Research Programs Awards Policies page for more information on this topic: American Heart Association Policies Governing All Research Awards