Exercise Magnetic Resonance Imaging in Patients With Obesity Associated Heart Failure

NCT06514820 | Recruiting

• 1 other identifier: EXPOSURE study
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

HFpEF - Heart Failure With Preserved Ejection Fraction

Keywords

Epicardial fat; HFpEF; Exercise MRI

Outcome Measures

Primary Outcomes (1)

• Ventricular interdependence

  the effect of epicardial fat on ventricular interdependence at peak exercise

  Baseline

Secondary Outcomes (8)

• VO2-max

  Baseline

• LV/RV diastolic strain rate

  Baseline

• slope of early LV/RV filling

  Baseline

• left and right atrial reservoir strain

  Baseline

• left and right atrial emptying fraction

  Baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, 9713GZ, Netherlands

RECRUITING

Study Officials

• Thomas M Gorter, MD, PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas M Gorter, MD, PhD

CONTACT

+3150 361 6161; tm.gorter@umcg.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: July 23, 2024
• Study Start: January 16, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)