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NCT Number: NCT07178145

Epicardial Adipose Tissue Composition and Heart Failure With Preserved Ejection Fraction

This study seeks to develop improved cardiac MRI (CMR) methods to quantify epicardial adipose tissue (EAT) composition and to demonstrate the advantages of EAT composition imaging (a) in advancing the understanding of the relationship between EAT and heart failure with preserved ejection fraction (HFpEF) and (b) for understanding mechanisms of and guiding medical therapy in HFpEF. The investigators recently developed the first method for quantifying EAT FAC in human subjects, utilizing a rate-6 accelerated radial 2D multi-echo gradient-echo breathhold acquisition with a local low rank reconstruction. In this project the first specific aim is to develop a rapid free-breathing 3D EAT FAC MRI method that reduces motion-related artifacts, increases coverage, and facilitates higher spatial resolution and improved FAC reproducibility. The second specific aim is to show that EAT FAC is more strongly associated than EAT volume with cardiometabolic HFpEF. In this context, individuals with known or suspected HFpEF will undergo CMR, echocardiography, and other testing to (a) diagnose cardiometabolic HFpEF; (b) characterize features associated with the severity of HFpEF; and (c) assess EAT volume and FAC. The investigators will determine if EAT FAC is more strongly associated than EAT volume with HFpEF and with features associated with the severity of HFpEF. The third specific aim is to show, in the context of cardiometabolic HFpEF and pre-HFpEF, (a) that GLP-1 receptor agonism with semaglutide (SEMA) shifts the EAT FAC to a less proinflammatory profile and (b) that baseline EAT FAC is a stronger predictor than EAT volume of improved cardiovascular function due to SEMA. Cardiometabolic HFpEF and pre-HFpEF subjects will undergo echocardiography and CMR with EAT FAC at baseline and after 3 months to serve as a self-control. Subjects will then undergo repeat imaging 6 months after the initiation of SEMA. The change in FAC after treatment with SEMA will be compared to the change in FAC prior to SEMA. Data will be analyzed to show that SEMA changes EAT FAC, and that baseline EAT FAC is a stronger predictor than EAT volume of improvements in severity of HFpEF.

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Key information

Conditions

Heart Failure Preserved Ejection Fraction Cardiovascular Diseases Epicardial Adipose Tissue Heart Diseases Heart Failure Heart Failure, Diastolic

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location status: Recruiting

Location contact

Amit Patel, MD

PRINCIPAL_INVESTIGATOR

Shuo Wang

CONTACT

[email protected]

434-982-1058

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years - 90 years;
  • LVEF ≥ 50%;
  • ≥ 2 risk factors for HFpEF or symptoms that could be related to HFpEF (e.g., dyspnea, orthopnea, paroxysmal nocturnal dyspnea, lower extremity edema, pulmonary edema, etc);
  • Not currently being treated with GLP-1RA therapy.

Exclusion criteria

  • • Previously or currently reduced EF (<50%), including heart transplant; (2) Obstructive un-revascularized coronary disease by coronary CT or invasive coronary angiography;
  • MI/PCI/CABG within the past 6 months;
  • Untreated severe stenotic or regurgitant valvular disease;
  • Infiltrative cardiomyopathy (Fabry/HCM/sarcoid/amyloid, etc);
  • Myocarditis;
  • Claustrophobia/inability to tolerate MRI;
  • Implants that are a contraindication for MRI or may negatively impact image quality (e.g. pacemakers and ICDs);
  • Active systemic inflammatory disorder;
  • Atrial fibrillation with rapid ventricular response at time of study; and
  • Hemodynamic instability
  • Pregnancy
  • Prisoners
  • Inability to provide informed consent

Exclusion criteria

for Optional Cardiac Stress Imaging Procedure

  • allergy to gadolinium-based contrast agents
  • Acute kidney injury
  • Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m²
  • Hepatorenal syndrome
  • History of liver transplant
  • High-grade atrioventricular (AV) block
  • Active asthma exacerbation
  • Known allergy to vasodilator agents
  • Recent seizure

Treatment and study plan

GLP-1RA

Drug

Receive 6 months of GLP-1RA (Semaglutide) treatment starting at 0.25mg once weekly and then the dose will be up titrated as tolerated every four weeks to once-weekly doses of 0.5, 1.0, 1.7, and 2.4 mg until a maximum dose of 2.4mg (or the subject's maximally tolerated dose, if the subject's maximally tolerated dose is <2.4 mg) is reached after 16 weeks.

Primary outcomes

  1. Epicardial adipose tissue (EAT) fatty acid composition (FAC)

    Time frame: Baseline, 3 months (self-control period), and 9-months (6 months post semaglutide treatment)

    The longitudinal change in epicardial adipose tissue (EAT) fatty acid composition (FAC) [quantified in terms of the fraction of saturated fatty acids (SFA) in units of %] that occur after 6 months of treatment with semaglutide will be compared to the change in SFA that occurred during 3 month period prior to the initiation of semaglutide.

Secondary outcomes

  1. EAT Volume

    Time frame: Baseline, 3months (self-control period), and 9-months (6 months post semaglutide treatment)

    The longitudinal change in epicardial adipose tissue (EAT) volume (ml) that occurs after 6 months of treatment with semaglutide will be compared to the change in SFA that occurred during 3 month period prior to the initiation of semaglutide.

  2. Baseline Saturated Fatty Acid Composition of Epicaridal Adipose Tissue and Change in Myocardial Deformation

    Time frame: Baseline, 3months (self-control period), and 9-months (6 months post semaglutide treatment)

    The cohort will be divided into 2 groups based on the median value of the epicardial adipose tissue saturated fatty acid composition. The change in global strain (%) following treatment with semaglutide will be compared between the groups.

  3. Baseline Saturated Fatty Acid Composition of Epicaridal Adipose Tissue and Change in diastolic dysfunction grade

    Time frame: Baseline, 3months (self-control period), and 9-months (6 months post semaglutide treatment)

    The cohort will be divided into 2 groups based on the median value of the epicardial adipose tissue saturated fatty acid composition. The change in diastolic dysfunction grade following treatment with semaglutide will be compared between the groups.

Study contacts

Contact information is provided by the study sponsor or research team.

Medard Ng

CONTACT

[email protected]

434-982-1058

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Sep 17, 2025
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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