Actively Recruiting

Phase 4
Age: 18Years - 90Years
All Genders
ID07178145

MRI of Epicardial Adipose Tissue Composition: Development of Methods and Application to Heart Failure With Preserved Ejection Fraction

Led by University of Virginia · Updated on 2026-05-05

192

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

Sponsors

U

University of Virginia

Lead Sponsor

N

National Institutes of Health (NIH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to develop advanced cardiac MRI methods to better measure the composition of epicardial adipose tissue (EAT) and to explore its relationship with heart failure with preserved ejection fraction (HFpEF), particularly cardiometabolic HFpEF. The study focuses on improving imaging techniques to reduce motion artifacts and improve resolution, and on assessing how EAT fatty acid composition (FAC) relates to HFpEF severity and response to treatment with semaglutide, a GLP-1 receptor agonist. Participants will undergo a series of imaging tests including cardiac MRI and echocardiography, along with medical history review, bloodwork, physical exams, and optional stress cardiac MRI. The study includes a baseline period with repeated imaging at 3 months to serve as a control, followed by 6 months of semaglutide treatment with further imaging at 9 months to evaluate changes in EAT FAC and heart function. During the trial, participants will be closely monitored through imaging and clinical assessments at baseline, after 3 months, and after 9 months post-treatment initiation. Researchers will measure EAT fatty acid composition and volume, heart function parameters, and symptoms to understand how semaglutide affects EAT and HFpEF. The total duration of participation is approximately 9 months, including treatment and follow-up imaging.

CONDITIONS

Brief Title

Epicardial Adipose Tissue Composition and Heart Failure With Preserved Ejection Fraction

Who Can Participate

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 90 years
  • Left ventricular ejection fraction (LVEF) of 50% or higher
  • At least 2 risk factors for heart failure with preserved ejection fraction or related symptoms such as shortness of breath, swelling in legs, or pulmonary edema
  • Not currently receiving GLP-1 receptor agonist therapy
Not Eligible

You will not qualify if you...

  • Reduced ejection fraction below 50% or history of heart transplant
  • Obstructive coronary disease not treated by surgery or intervention
  • Heart attack, PCI, or bypass surgery within past 6 months
  • Severe untreated valvular heart disease
  • Infiltrative heart diseases like Fabry disease, hypertrophic cardiomyopathy, sarcoidosis, or amyloidosis
  • Myocarditis
  • Claustrophobia or inability to tolerate MRI
  • Implants that prevent MRI or reduce image quality such as pacemakers or ICDs
  • Active systemic inflammatory disorders
  • Atrial fibrillation with rapid heartbeat during study
  • Hemodynamic instability
  • Pregnancy
  • Prisoner status
  • Inability to give informed consent
  • Allergy to gadolinium contrast, acute kidney injury, low kidney function, hepatorenal syndrome, liver transplant history, high-grade AV block, active asthma attack, known allergy to vasodilators, or recent seizure (for optional cardiac stress imaging)

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 3 months self-control period

Participants undergo cardiac MRI, exercise echocardiography, 12 lead ECG, medical history review, bloodwork, physical exam, and optional stress cardiac MRI to assess heart function and epicardial adipose tissue.

Multiple visits during the 3 months

Treatment

Duration - 6 months

Participants receive GLP-1RA (Semaglutide) treatment starting at 0.25mg once weekly with dose escalations every four weeks up to a maximum tolerated dose for a total of 6 months.

Weekly dosing with periodic assessments before and after treatment

Diagnostic Evaluation

Duration - Post-treatment assessment at 9 months

Participants undergo repeat cardiac MRI and other assessments to evaluate the effect of treatment on epicardial adipose tissue and heart function.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

University of Virginia

Charlottesville, Virginia, United States, 22903

Actively Recruiting

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Research Team

M

Medard Ng

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

DIAGNOSTIC

Number of Arms

3

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