Investigating the impact of epicardial fat on heart function in obese patients with heart failure
EXercise Magnetic Resonance Imaging in Patients With Obesity aSsociated Heart failURe With Preserved Ejection Fraction (EXPOSURE) Study
This study is testing how the amount of fat around the heart affects heart function during exercise in obese patients with heart failure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Medical Center Groningen Academic / other |
| Locations | 1 site (Groningen) |
| Trial ID | NCT06514820 on ClinicalTrials.gov |
What this trial studies
The EXPOSURE study aims to explore how epicardial fat affects cardiac function and pulmonary artery response during exercise in patients with heart failure with preserved ejection fraction (HFpEF). This observational study will include 50 patients who will be categorized based on their epicardial fat volume measured through cardiac magnetic resonance imaging (CMR). The primary focus is to assess differences in left ventricular (LV) function at peak exercise between those with high and low epicardial fat. Secondary outcomes will include various measures of cardiac performance and function during exercise, with comparisons made between genders.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with signs and symptoms of heart failure and preserved ejection fraction.
Not a fit: Patients with significant arrhythmias, severe obesity (body weight >140 kg), or contraindications for CMR may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and management of heart failure in patients with obesity.
How similar studies have performed: While the specific approach of this study is novel, previous studies have indicated a relationship between epicardial fat and heart function, suggesting potential for meaningful insights.
Eligibility criteria
Show full inclusion / exclusion criteria
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 (Figure 1). 4. \>18 years of age 5. In sinus rhythm 6. Able to perform a bicycle exercise test 7. Willing to sign informed consent Exclusion Criteria: 1. Body weight \>140 kg 2. Atrial fibrillation or other significant arrhythmia 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.
Where this trial is running
Groningen
- University Medical Center Groningen — Groningen, Netherlands (Recruiting)
Study contacts
- Principal investigator: Thomas M Gorter, MD, PhD — University Medical Center Groningen
- Study coordinator: Thomas M Gorter, MD, PhD
- Email: tm.gorter@umcg.nl
- Phone: +3150 361 6161
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.