University Medical Center Groningen
Groningen, 9713GZ, Netherlands
Location status: Recruiting
Location contact
Thomas M Gorter, MD, PhD
CONTACT
NCT Number: NCT06514820
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Groningen, 9713GZ, Netherlands
Location status: Recruiting
Thomas M Gorter, MD, PhD
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline
the effect of epicardial fat on ventricular interdependence at peak exercise
Time frame: Baseline
the effect of epicardial fat on VO2-max at peak exercise
Time frame: Baseline
the effect of epicardial fat on ventricular diastolic strain rate measured on echocardiography at peak exercise
Time frame: Baseline
the effect of epicardial fat on slope of early ventricular filling measured on echocardiography at peak exercise
Time frame: Baseline
the effect of epicardial fat on atrial emptying fraction measured on echocardiography at peak exercise
Time frame: Baseline
the effect of epicardial fat on atrial reservoir strain measured on echocardiography at peak exercise
Time frame: Baseline
the effect of epicardial fat on pulmonary artery distensibility measured on echocardiography at peak exercise
Time frame: Baseline
the effect of epicardial fat on pulmonary artery pulsatility measured on echocardiography at peak exercise
Time frame: Baseline
the effect of epicardial fat on cardiac output at peak exercise
Contact information is provided by the study sponsor or research team.
University Medical Center Groningen
Other
EXercise Magnetic Resonance Imaging in Patients With Obesity aSsociated Heart failURe With Preserved Ejection Fraction (EXPOSURE) Study
Acronym: EXPOSURE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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