Exercise Magnetic Resonance Imaging in Patients With Obesity Associated Heart Failure

NCT ID: NCT06514820

Last Updated: 2024-07-23

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-16
• Study Completion Date: 2025-12-31

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 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

HFpEF - Heart Failure With Preserved Ejection Fraction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas M Gorter, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UMCG

Locations

University Medical Center Groningen

Groningen, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Thomas M Gorter, MD, PhD

Role: CONTACT

tm.gorter@umcg.nl

+3150 361 6161

Facility Contacts

Thomas M Gorter, MD, PhD

Role: primary

Other Identifiers

EXPOSURE study

Identifier Type: -

Identifier Source: org_study_id