Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06514820
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-03
Brief Title:
Exercise Magnetic Resonance Imaging in Patients With Obesity Associated Heart Failure
Sponsor:
None
Organization:
None
Study Overview
Official Title:
EXercise Magnetic Resonance Imaging in Patients With Obesity aSsociated Heart failURe With Preserved Ejection Fraction EXPOSURE Study
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EXPOSURE
Brief 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 LVRV 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 LVRV diastolic strain rate change in slope of LVRV 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None