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Epicardial Adipose Tissue Composition and Heart Failure With Preserved Ejection Fraction Phase 4 192

Not yet recruiting
Clinical Trial NCT07178145 is designed to study Diagnostic for Heart Failure Preserved Ejection Fraction, Epicardial Adipose Tissue. This Phase 4 interventional study is not yet recruiting. Enrollment is planned to begin on September 1, 2025 until the study accrues 192 participants. Led by University of Virginia, this study is expected to complete by December 1, 2029. The latest data from ClinicalTrials.gov was last updated on September 17, 2025.
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 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...Show More
Official Title

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

Conditions
Heart Failure Preserved Ejection FractionEpicardial Adipose Tissue
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • 302641
NCT ID Number
NCT07178145
Start Date (Actual)
2025-09
Last Update Posted
2025-09-17
Completion Date (Estimated)
2029-12
Enrollment (Estimated)
192
Study Type
Interventional
PHASE
Phase 4
Status
Not yet recruiting
Keywords
HFpEF
Heart Failure preserved Ejection Fraction
Cardiac MRI
Epicardial Adipose Tissue
GLP-1
EAT FAC
cardiovascular function
Primary Purpose
Diagnostic
Design Allocation
Non-Randomized
Interventional Model
Sequential
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
No Intervention3D EAT FAC CMR imaging
non-contrast MRI to debug/test 3D MRI techniques for quantifying EAT FAC
N/A
No InterventionImaging acquisition and medical condition overview
Will undergo Cardiac MRI, exercise echocardiography, 12 lead ECG, medical history review, bloodwork, physical exam, and optional stress cardiac MRI.
N/A
ExperimentalImaging acquisition and GLP-1RA treatment
Will undergo all testing before and after a 6-month treatment of GLP-1RA
GLP-1RA
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 target dose of 2.4mg is reached after 16 weeks.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Epicardial adipose tissue (EAT) fatty acid composition (FAC)
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.
Baseline, 3 months (self-control period), and 9-months (6 months post semaglutide treatment)
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
EAT Volume
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.
Baseline, 3months (self-control period), and 9-months (6 months post semaglutide treatment)
Baseline Saturated Fatty Acid Composition of Epicaridal Adipose Tissue and Change in Myocardial Deformation
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.
Baseline, 3months (self-control period), and 9-months (6 months post semaglutide treatment)
Baseline Saturated Fatty Acid Composition of Epicaridal Adipose Tissue and Change in diastolic dysfunction grade
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.
Baseline, 3months (self-control period), and 9-months (6 months post semaglutide treatment)
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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.

  • • 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
University of Virginia logoUniversity of Virginia294 active studies to explore
National Institutes of Health (NIH) logoNational Institutes of Health (NIH)
Study Responsible Party
Amit R. Patel, Principal Investigator, Principal Investigator, University of Virginia
Study Central Contact
Contact: Shuo Wang, 434-982-1058, [email protected]
1 Study Locations in 1 Countries

Virginia

University of Virginia, Charlottesville, Virginia, 22903, United States
Shuo Wang, Contact, 434-982-1058, [email protected]
Amit Patel, MD, Principal Investigator