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Heart Failure Preserved Ejection Fraction / Epicardial Adipose Tissue / GLP-1RA · Phase 4 Trial
ClinicalTrials.gov · August 11, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a recruiting Phase 4 trial designed to validate cardiac MRI methods for measuring epicardial adipose tissue fatty acid composition and to test whether GLP-1 agonism (semaglutide) modifies this composition in heart failure with preserved ejection fraction. No efficacy or safety results are available in this registry record; the trial is actively enrolling.
Phase 4, Interventional, Non Randomized, Sequential, Open label, Diagnostic purpose. Heart Failure Preserved Ejection Fraction, Epicardial Adipose Tissue; age from 18 Years; to 90 Years. Intervention: Imaging acquisition and GLP-1RA treatment. Compared with: 3D EAT FAC CMR imaging — No Intervention; Imaging acquisition and medical condition overview — No Intervention. n = 192. 1 site: United States.
This is a recruiting Phase 4 trial designed to validate cardiac MRI methods for measuring epicardial adipose tissue fatty acid composition and to test whether GLP-1 agonism (semaglutide) modifies this composition in heart failure with preserved ejection fraction. No efficacy or safety results are available in this registry record; the trial is actively enrolling.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
If completed successfully, this work could establish EAT fatty acid composition as a biomarker superior to EAT volume for understanding HFpEF severity and predicting response to GLP-1 agonism. Clinical utility will depend on validation of the novel MRI method and demonstration of clinical outcome benefit.
This is a recruiting interventional trial testing novel cardiac MRI methods and exploring GLP-1 agonism in HFpEF; no results are posted in this registry record.
As stated by the source record.
Quoted from the source exactly as published.
If completed successfully, this work could establish EAT fatty acid composition as a biomarker superior to EAT volume for understanding HFpEF severity and predicting response to GLP-1 agonism. Clinical utility will depend on validation of the novel MRI method and demonstration of clinical outcome benefit.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07178145). This is a study registration, not published results. Lead sponsor: University of Virginia. Recruitment status: RECRUITING. Phase: PHASE4. Study type: INTERVENTIONAL. Enrollment: 192 participants (ESTIMATED). Conditions: Heart Failure Preserved Ejection Fraction, Epicardial Adipose Tissue. Interventions: DRUG: GLP-1RA. Primary outcome measures: Epicardial adipose tissue (EAT) fatty acid composition (FAC) , Baseline, 3 months (self-control period), and 9-months (6 months post semaglutide treatment). 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 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.
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