Status:
NOT_YET_RECRUITING
Epicardial Adipose Tissue Composition and Heart Failure With Preserved Ejection Fraction
Lead Sponsor:
University of Virginia
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Heart Failure Preserved Ejection Fraction
Epicardial Adipose Tissue
Eligibility:
All Genders
18-90 years
Phase:
PHASE4
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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 or SGLT2i therapy.
Exclusion
- • 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
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
192 Patients enrolled
Trial Details
Trial ID
NCT07178145
Start Date
September 1 2025
End Date
December 1 2029
Last Update
September 17 2025
Active Locations (1)
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1
University of Virginia
Charlottesville, Virginia, United States, 22903