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Epicardial Adipose Tissue Composition and Heart Failure With Preserved Ejection Fraction

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 90 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests better heart MRI scans to measure the makeup of fat around the heart. It is for adults who may have heart failure even though the heart pumps a normal share of blood. It also tests whether semaglutide changes this fat and whether the scans can help predict who benefits from the drug.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 to 90 years old.
  • Your heart pumps out at least 50% of the blood in its main pumping chamber with each beat.
  • You have at least 2 risk factors for this type of heart failure, or possible symptoms, such as trouble breathing or swollen legs.
  • You are not taking a GLP-1 receptor agonist, a type of medicine that includes semaglutide.

Who can't join

  • Your heart pumps out less than 50% of its blood now or did in the past, or you have had a heart transplant.
  • You have blocked heart arteries that have not been treated to restore blood flow, or had a heart attack, artery-opening procedure, or heart bypass surgery in the past 6 months.
  • You have untreated severe narrowing or leaking of a heart valve, certain heart muscle diseases, or swelling of the heart muscle.
  • You cannot tolerate MRI, fear tight spaces, or have an implant that makes MRI unsafe or lowers scan quality.
  • You have an active illness causing inflammation throughout the body, a fast irregular heartbeat called atrial fibrillation at the study visit, or unstable blood pressure or blood flow.
  • You are pregnant, are a prisoner, or cannot give informed consent to join.
  • For optional heart stress imaging only: allergy to MRI contrast dye, sudden kidney injury, kidney filtering rate below 30, kidney failure linked to liver disease, or a past liver transplant.
  • For optional heart stress imaging only: a serious block in the heart’s electrical signals, a current asthma flare-up, allergy to drugs that widen blood vessels, or a recent seizure.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (1)

VA