Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2025-12-26 @ 3:25 AM
Study NCT ID:
NCT06514820
Status:
RECRUITING
Last Update Posted:
2024-07-23
First Post:
2024-07-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exercise Magnetic Resonance Imaging in Patients With Obesity Associated Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-16', 'studyFirstSubmitDate': '2024-07-03', 'studyFirstSubmitQcDate': '2024-07-16', 'lastUpdatePostDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ventricular interdependence', 'timeFrame': 'Baseline', 'description': 'the effect of epicardial fat on ventricular interdependence at peak exercise'}], 'secondaryOutcomes': [{'measure': 'VO2-max', 'timeFrame': 'Baseline', 'description': 'the effect of epicardial fat on VO2-max at peak exercise'}, {'measure': 'LV/RV diastolic strain rate', 'timeFrame': 'Baseline', 'description': 'the effect of epicardial fat on ventricular diastolic strain rate measured on echocardiography at peak exercise'}, {'measure': 'slope of early LV/RV filling', 'timeFrame': 'Baseline', 'description': 'the effect of epicardial fat on slope of early ventricular filling measured on echocardiography at peak exercise'}, {'measure': 'left and right atrial reservoir strain', 'timeFrame': 'Baseline', 'description': 'the effect of epicardial fat on atrial emptying fraction measured on echocardiography at peak exercise'}, {'measure': 'left and right atrial emptying fraction', 'timeFrame': 'Baseline', 'description': 'the effect of epicardial fat on atrial reservoir strain measured on echocardiography at peak exercise'}, {'measure': 'pulmonary artery distensibility', 'timeFrame': 'Baseline', 'description': 'the effect of epicardial fat on pulmonary artery distensibility measured on echocardiography at peak exercise'}, {'measure': 'pulmonary artery pulsatility', 'timeFrame': 'Baseline', 'description': 'the effect of epicardial fat on pulmonary artery pulsatility measured on echocardiography at peak exercise'}, {'measure': 'cardiac output', 'timeFrame': 'Baseline', 'description': 'the effect of epicardial fat on cardiac output at peak exercise'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Epicardial fat', 'HFpEF', 'Exercise MRI'], 'conditions': ['HFpEF - Heart Failure With Preserved Ejection Fraction']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Signs and symptoms of HF according to the Europeans Society of Cardiology guideline.\n2. LV ejection fraction ≥40%.\n3. HFA-PEFF score ≥5 or HFA-PEFF score 2-4 in combination with positive stress test (Figure 1).\n4. \\>18 years of age\n5. In sinus rhythm\n6. Able to perform a bicycle exercise test\n7. Willing to sign informed consent\n\nExclusion Criteria:\n\n1. Body weight \\>140 kg\n2. Atrial fibrillation or other significant arrhythmia during the assessment\n3. Contraindications for CMR (e.g. claustrophobia, implanted cardiac devices)\n4. Myocardial infarction, percutaneous coronary intervention or coronary artery bypass graft \\<3 months or untreated severe obstructive coronary artery stenosis\n5. More than moderate left-sided valve disease.\n6. Complex congenital heart disease.'}, 'identificationModule': {'nctId': 'NCT06514820', 'acronym': 'EXPOSURE', 'briefTitle': 'Exercise Magnetic Resonance Imaging in Patients With Obesity Associated Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'University Medical Center Groningen'}, 'officialTitle': 'EXercise Magnetic Resonance Imaging in Patients With Obesity aSsociated Heart failURe With Preserved Ejection Fraction (EXPOSURE) Study', 'orgStudyIdInfo': {'id': 'EXPOSURE study'}}, 'contactsLocationsModule': {'locations': [{'zip': '9713GZ', 'city': 'Groningen', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Thomas M Gorter, MD, PhD', 'role': 'CONTACT'}], 'facility': 'University Medical Center Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}], 'centralContacts': [{'name': 'Thomas M Gorter, MD, PhD', 'role': 'CONTACT', 'email': 'tm.gorter@umcg.nl', 'phone': '+3150 361 6161'}], 'overallOfficials': [{'name': 'Thomas M Gorter, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Center Groningen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medical Center Groningen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}