Measuring the fat around the heart in people with HFpEF
MRI of Epicardial Adipose Tissue Composition: Development of Methods and Application to Heart Failure With Preserved Ejection Fraction
This research will test a new free-breathing 3D cardiac MRI to measure epicardial fat composition and see if those measurements link to symptoms or help guide treatment for people with HFpEF.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 192 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | University of Virginia Academic / other |
| Locations | 1 site (Charlottesville, Virginia) |
| Trial ID | NCT07178145 on ClinicalTrials.gov |
What this trial studies
Researchers will develop a rapid, free-breathing three-dimensional cardiac MRI method to quantify epicardial adipose tissue fat composition (FAC) with reduced motion artifacts and higher spatial resolution. The trial enrolls adults with preserved ejection fraction (LVEF ≥50%) who have at least two HFpEF risk factors or symptoms and who are not currently on GLP‑1 receptor agonists. Investigators will compare EAT FAC against traditional EAT volume measures to determine which better correlates with cardiometabolic features and the HFpEF clinical phenotype. Imaging data may also be used to explore mechanisms and inform responses to medical therapies such as GLP‑1 receptor agonists.
Who should consider this trial
Good fit: Adults aged 18–90 with left ventricular ejection fraction ≥50% who have at least two HFpEF risk factors or compatible symptoms and are not currently using GLP‑1 receptor agonists are ideal candidates.
Not a fit: Patients with reduced EF (<50%), MRI contraindications (such as incompatible implants or severe claustrophobia), recent MI or unstable cardiac conditions, active systemic inflammatory disease, or those already taking GLP‑1 receptor agonists are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the method could provide a more precise imaging biomarker to identify patients at risk, clarify disease mechanisms, and better target therapies for HFpEF.
How similar studies have performed: The investigators recently developed the first human method to quantify EAT FAC, so the imaging approach is novel while prior work linking EAT volume to HFpEF offers supporting context.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Charlottesville, Virginia
- University of Virginia — Charlottesville, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Amit Patel, MD — University of Virginia
- Study coordinator: Medard Ng
- Email: HTN3U@uvahealth.org
- Phone: 434-982-1058
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.