EXercise magnetic resonance imaging in Patients with Obesity aSsociated heart failURe with preserved Ejection fraction (EXPOSURE) study

Recruiting

Conditions: adipose tissue around the heart
Heart failure
10082206

Registration Number: NL-OMON51285

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

1. Signs and symptoms of HF according to the Europeans Society of Cardiology
guideline.
2. LV ejection fraction >=40%.
3. HFA-PEFF score >=5 or HFA-PEFF score 2-4 in combination with positive stress
test
4. >18 years of age
5. Able to perform a bicycle exercise test
6. Willing to sign informed consent

Exclusion Criteria

1. Body weight >140 kg
2. Uncontrolled atrial fibrillation or other significant arrhythmia with
resting heart rate >110 bpm during the assessment
3. Contraindications for CMR (e.g. claustrophobia, implanted cardiac devices)
4. Myocardial infarction, percutaneous coronary intervention or coronary
artery bypass graft <3 months or untreated severe obstructive coronary
artery stenosis
5. More than moderate left-sided valve disease.
6. Complex congenital heart disease.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Patients will be stratified according to high (>=100 ml/m2) and low (<100 ml/m2)<br /><br>epicardial fat volume measured with CMR. The primary outcome parameter is the<br /><br>difference in LV eccentricity index at peak exercise between the two groups. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Pre-specified secondary outcome parameters between the subgroups are: 1)<br /><br>VO2-max, 2) LV and right ventricular (RV) diastolic strain rate, 3) slope of<br /><br>early LV/RV filling, 3) left and right atrial reservoir strain and emptying<br /><br>fraction, 4) pulmonary artery distensibility and pulsatility and 5) cardiac<br /><br>output, all at peak exercise. The amount of epicardial fat will be correlated<br /><br>with change in LV eccentricity index from rest to peak exercise, change in<br /><br>LV/RV diastolic strain rate, change in slope of LV/RV filling, change in atrial<br /><br>reservoir strain and emptying fraction, change in pulmonary artery<br /><br>distensibility and pulsatility, and change in cardiac output. All results will<br /><br>be also compared between men and women.</p><br>