GLP-1RA for Heart Failure

Overseen By Shuo Wang

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Virginia

Must not be taking: GLP-1RA, SGLT2i

Disqualifiers: Reduced EF, Coronary disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve understanding and treatment of heart failure with preserved ejection fraction (HFpEF), a condition where the heart pumps normally but is too stiff to fill properly. Researchers are testing semaglutide, a diabetes drug that may benefit the heart, to determine if it can positively change the heart's fat tissue and improve heart function. Participants will undergo various heart imaging tests to measure these changes. The trial seeks individuals with heart failure symptoms, such as shortness of breath or leg swelling, who are not currently receiving certain heart medications. As a Phase 4 trial, this research focuses on how the already FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot be on GLP-1RA or SGLT2i therapy to participate.

What is the safety track record for semaglutide?

Research shows that semaglutide is generally safe for people. In past studies, semaglutide lowered the risk of heart problems in people with diabetes. For instance, one study reported a 76% drop in hospital visits due to heart failure with semaglutide use. Another study observed a 17% decrease in deaths related to heart issues.

These results suggest that semaglutide is well-tolerated and may support heart health, especially in those with obesity or diabetes. While no treatment is without risk, the evidence so far indicates that semaglutide has a good safety record for heart-related conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using semaglutide for heart failure because it offers a different approach from traditional treatments like beta-blockers and ACE inhibitors. Semaglutide is a GLP-1 receptor agonist, originally used for diabetes, that helps improve heart function by reducing inflammation and oxidative stress. Unlike typical heart failure drugs, which often work by affecting blood pressure and heart rate, semaglutide targets metabolic pathways, offering a potential dual benefit for patients with both heart failure and metabolic issues. This unique mechanism could lead to better management of heart failure symptoms and improved quality of life for patients.

What evidence suggests that this trial's treatments could be effective for heart failure?

Research has shown that semaglutide, a type of medication, effectively improves heart failure with preserved ejection fraction (HFpEF). One study found that semaglutide significantly reduced heart failure symptoms and improved heart function in patients. Another study discovered that it lowered the risk of major heart-related events in patients with obesity. Additionally, semaglutide enhanced the quality of life for people with HFpEF. In this trial, participants in the "Imaging acquisition and GLP-1RA treatment" arm will receive semaglutide to further evaluate its impact on heart failure. Overall, these findings suggest that semaglutide can positively impact those dealing with heart failure. ^{1 3 4 6 7}

Who Is on the Research Team?

Amit Patel, MD

Principal Investigator

University of Virginia

Are You a Good Fit for This Trial?

This trial is for individuals with known or suspected heart failure with preserved ejection fraction (HFpEF), which means their hearts pump normally but still fail to supply enough blood. Participants should be able to undergo cardiac MRI and other tests.

Inclusion Criteria

I am between 18 and 90 years old.

I have symptoms or at least 2 risk factors for a specific type of heart failure.

I am not currently on GLP-1RA or SGLT2i medications.

Exclusion Criteria

I have had or currently have a weak heart (ejection fraction <50%) or a heart transplant.

I have blocked arteries in my heart that haven't been treated with surgery.

I have not had a heart attack or heart surgery in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline cardiac MRI, echocardiography, and other testing to diagnose and characterize HFpEF

1-2 weeks

1 visit (in-person)

Self-control Period

Participants undergo echocardiography and CMR with EAT FAC at baseline and after 3 months to serve as a self-control

3 months

2 visits (in-person)

Treatment

Participants receive GLP-1 receptor agonism with semaglutide for 6 months

6 months

1 visit (in-person) every 3 months

Follow-up

Participants are monitored for changes in EAT FAC and cardiovascular function after treatment

3 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Semaglutide

Trial Overview The study is testing a new method of using cardiac MRI to measure the fat around the heart and its association with HFpEF. It also examines if a drug called semaglutide can change this fat composition and improve heart function in HFpEF patients.

How Is the Trial Designed?

Group I: Imaging acquisition and GLP-1RA treatment Experimental Treatment 1 Intervention

Will undergo all testing before and after a 6-month treatment of GLP-1RA

Group II: Imaging acquisition and medical condition overview Active Control 1 Intervention

Will undergo Cardiac MRI, exercise echocardiography, 12 lead ECG, medical history review, bloodwork, physical exam, and optional stress cardiac MRI.

Group III: 3D EAT FAC CMR imaging Active Control 1 Intervention

non-contrast MRI to debug/test 3D MRI techniques for quantifying EAT FAC

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials

802

Recruited

1,342,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Citations

1. jacc.org jacc.org/doi/10.1016/j.jacc.2024.08.016

Effects of GLP-1 Receptor Agonists on Heart Failure ... In obesity-related heart failure with preserved ejection fraction (HFpEF), semaglutide significantly improved HF-related symptoms and reduced HF ...

2. nejm.org nejm.org/doi/full/10.1056/NEJMoa2307563

Semaglutide and Cardiovascular Outcomes in Obesity ... A primary cardiovascular end-point event occurred in 569 of the 8803 patients (6.5%) in the semaglutide group and in 701 of the 8801 patients (8.0%) in the ...

3. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(25)01375-3/fulltext

Semaglutide and cardiovascular outcomes by baseline ... The SELECT trial found semaglutide reduced major adverse cardiovascular events (MACE) in patients with overweight or obesity with ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1071916425000910

Efficacy of GLP-1 Receptor Agonists in Patients With Heart ... In conclusion, GLP-1RAs significantly reduce the risk of worsening HF events and the composite outcome of CV death or worsening HF in patients with HFpEF and ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40786355/

Semaglutide in Heart Failure With Preserved Ejection ... Semaglutide significantly improves HFpEF outcomes in obese patients, with STEP HFpEF (n = 529) and STEP HFpEF DM (n = 616) demonstrating Kansas ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39396098/

Semaglutide effects: safety & CV outcomes in overweight/obesity Conclusion: The use of semaglutide reduced 76% in hospitalization due to HF, 17% deaths due to cardiovascular causes, 21% deaths due to any ...

7. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.124.071689

Cardiovascular, Kidney, and Safety Outcomes With GLP-1 ... In the FLOW trial, semaglutide reduced the risk of CKD progression, kidney failure, or cardiovascular or kidney failure–related death by 24% in ...