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NCT07178145 · ClinicalTrials.gov registry record · Phase 4
Epicardial Adipose Tissue Composition and Heart Failure With Preserved Ejection Fraction
A Phase 4 study, sponsored by University of Virginia.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 192
- Enrollment target
NCT07178145 is a Phase 4 study that is actively recruiting participants, run by University of Virginia. The registered enrollment target is 192 participants.
The verdict
NCT07178145, a Phase 4 study, is actively recruiting participants, sponsored by University of Virginia.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 192 participants
- Enrollment target
Study 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
Interventions
- DRUG GLP-1RA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 192 participants |
| Start Date | 2025-11-20 |
| Est. Completion | 2029-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07178145
The ClinicalTrials.gov registry entry for NCT07178145 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 192 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Virginia, which has 449 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which GLP-1RA is the first listed.
NCT07178145 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07178145 about?
NCT07178145 is a clinical study titled "Epicardial Adipose Tissue Composition and Heart Failure With Preserved Ejection Fraction". 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 (H...
What is the current status of trial NCT07178145?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 192 participants. The study started on 2025-11-20. Estimated completion is 2029-12.
What interventions are being tested in trial NCT07178145?
The interventions under investigation include: GLP-1RA (DRUG).
Who is sponsoring clinical trial NCT07178145?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
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