Exercise Magnetic Resonance Imaging in Patients With Obesity Associated Heart Failure (EXPOSURE)

EXercise Magnetic Resonance Imaging in Patients With Obesity aSsociated Heart failURe With Preserved Ejection Fraction (EXPOSURE) Study

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.

Study Overview

• Status: Recruiting
• Conditions: HFpEF - Heart Failure With Preserved Ejection Fraction

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.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Thomas M Gorter, MD, PhD; Phone Number: +3150 361 6161; Email: tm.gorter@umcg.nl

Study Locations

• Netherlands
  • Groningen, Netherlands, 9713GZ
    • Recruiting
    • University Medical Center Groningen
    • Contact: Thomas M Gorter, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

A cohort of 50 patients with HFpEF, in which the effects of epicardial fat on cardiac function, pericardial constraint and pulmonary artery vasodilatation will be tested using cardiac magnetic resonance (CMR) imaging at rest and during exercise stress testing.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ventricular interdependence	the effect of epicardial fat on ventricular interdependence at peak exercise	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VO2-max	the effect of epicardial fat on VO2-max at peak exercise	Baseline
LV/RV diastolic strain rate	the effect of epicardial fat on ventricular diastolic strain rate measured on echocardiography at peak exercise	Baseline
slope of early LV/RV filling	the effect of epicardial fat on slope of early ventricular filling measured on echocardiography at peak exercise	Baseline
left and right atrial reservoir strain	the effect of epicardial fat on atrial emptying fraction measured on echocardiography at peak exercise	Baseline
left and right atrial emptying fraction	the effect of epicardial fat on atrial reservoir strain measured on echocardiography at peak exercise	Baseline
pulmonary artery distensibility	the effect of epicardial fat on pulmonary artery distensibility measured on echocardiography at peak exercise	Baseline
pulmonary artery pulsatility	the effect of epicardial fat on pulmonary artery pulsatility measured on echocardiography at peak exercise	Baseline
cardiac output	the effect of epicardial fat on cardiac output at peak exercise	Baseline

Collaborators and Investigators

• Sponsor: University Medical Center Groningen
• Investigators: Principal Investigator: Thomas M Gorter, MD, PhD, UMCG

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: July 3, 2024
• First Submitted That Met QC Criteria: July 16, 2024
• First Posted (Actual): July 23, 2024

Study Record Updates

• Last Update Posted (Actual): July 23, 2024
• Last Update Submitted That Met QC Criteria: July 16, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: HFpEF; Epicardial fat; Exercise MRI
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: EXPOSURE study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No