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New treatment option for Heart Failure Preserved Ejection Fraction
Official title Epicardial Adipose Tissue Composition and Heart Failure With Preserved Ejection Fraction
ClinicalTrials.gov ID: NCT07178145
What this study is testing
What is GLP-1RA?
GLP-1RA is an investigational medicine, given as an once-weekly, being studied as a potential treatment for heart failure preserved ejection fraction.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90
You may be able to join if
- 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...
- Not currently being treated with GLP-1RA therapy.
You likely can't join if
- Previously or currently reduced EF (\<50%), including heart transplant; (2) Obstructive un-revascularized coronary disease by coronary CT or invasive...
- 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;
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Charlottesville, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Charlottesville, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.