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NCT Number: NCT06514820

Exercise Magnetic Resonance Imaging in Patients With Obesity Associated Heart Failure

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Groningen

Groningen, 9713GZ, Netherlands

Location status: Recruiting

Location contact

Thomas M Gorter, MD, PhD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Body weight >140 kg
  • Atrial fibrillation or other significant arrhythmia during the assessment
  • Contraindications for CMR (e.g. claustrophobia, implanted cardiac devices)
  • Myocardial infarction, percutaneous coronary intervention or coronary artery bypass graft <3 months or untreated severe obstructive coronary artery stenosis
  • More than moderate left-sided valve disease.
  • Complex congenital heart disease.

Treatment and study plan

Primary outcomes

  1. Ventricular interdependence

    Time frame: Baseline

    the effect of epicardial fat on ventricular interdependence at peak exercise

Secondary outcomes

  1. VO2-max

    Time frame: Baseline

    the effect of epicardial fat on VO2-max at peak exercise

  2. LV/RV diastolic strain rate

    Time frame: Baseline

    the effect of epicardial fat on ventricular diastolic strain rate measured on echocardiography at peak exercise

  3. slope of early LV/RV filling

    Time frame: Baseline

    the effect of epicardial fat on slope of early ventricular filling measured on echocardiography at peak exercise

  4. left and right atrial reservoir strain

    Time frame: Baseline

    the effect of epicardial fat on atrial emptying fraction measured on echocardiography at peak exercise

  5. left and right atrial emptying fraction

    Time frame: Baseline

    the effect of epicardial fat on atrial reservoir strain measured on echocardiography at peak exercise

  6. pulmonary artery distensibility

    Time frame: Baseline

    the effect of epicardial fat on pulmonary artery distensibility measured on echocardiography at peak exercise

  7. pulmonary artery pulsatility

    Time frame: Baseline

    the effect of epicardial fat on pulmonary artery pulsatility measured on echocardiography at peak exercise

  8. cardiac output

    Time frame: Baseline

    the effect of epicardial fat on cardiac output at peak exercise

Study contacts

Contact information is provided by the study sponsor or research team.

Thomas M Gorter, MD, PhD

CONTACT

[email protected]

+3150 361 6161

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study title

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

Acronym: EXPOSURE

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 23, 2024
Registry last updated
Jul 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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