Clinical Trials Directory

Trials / Recruiting

RecruitingNCT06514820

Exercise Magnetic Resonance Imaging in Patients With Obesity Associated Heart Failure

EXercise Magnetic Resonance Imaging in Patients With Obesity aSsociated Heart failURe With Preserved Ejection Fraction (EXPOSURE) Study

Status
Recruiting
Phase
Study type
Observational
Enrollment
50 (estimated)
Sponsor
University Medical Center Groningen · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

To aim of the EXPOSURE study is to investigate the effects of epicardial fat on cardiac function, pericardial constraint and pulmonary artery vasodilatation using cardiac magnetic resonance (CMR) imaging at rest and during exercise stress testing in patients with HFpEF.

Detailed description

The EXPOSURE study investigates the effects of epicardial fat on ventricular interdependence at peak exercise. Epicardial fat, the visceral fat situated directly adjacent to the heart, seems involved in the pathophysiology of heart failure with preserved ejection fraction (HFpEF). It has been suggested that an abundance of epicardial fat surrounding the heart within a closed pericardial sac may constrain the heart leading to ventricular interdependence. The study is an investigator initiatied, cross-sectional, observational study, including 50 patients with HFpEF. Patients will be stratified according to high and low epicardial fat volume measured with CMR. The primary outcome parameter is the difference in LV eccentricity index at peak exercise between the two groups. Pre-specified secondary outcome parameters between the subgroups are: 1) VO2-max, 2) LV and right ventricular (RV) diastolic strain rate, 3) slope of early LV/RV filling, 3) left and right atrial reservoir strain and emptying fraction, 4) pulmonary artery distensibility and pulsatility and 5) cardiac output, all at peak exercise. The amount of epicardial fat will be correlated with change in LV eccentricity index from rest to peak exercise, change in LV/RV diastolic strain rate, change in slope of LV/RV filling, change in atrial reservoir strain and emptying fraction, change in pulmonary artery distensibility and pulsatility, and change in cardiac output. All results will be also compared between men and women.

Conditions

Timeline

Start date
2024-01-16
Primary completion
2025-12-31
Completion
2025-12-31
First posted
2024-07-23
Last updated
2024-07-23

Locations

1 site across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT06514820. Inclusion in this directory is not an endorsement.