Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-01-01 @ 12:15 AM
Study NCT ID:
NCT05068934
Status:
COMPLETED
Last Update Posted:
2021-10-06
First Post:
2021-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Relationship Between Epicardial Fat Tissue and Cardiac Function in HFpEF Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 93}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-26', 'studyFirstSubmitDate': '2021-09-26', 'studyFirstSubmitQcDate': '2021-09-26', 'lastUpdatePostDateStruct': {'date': '2021-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Epicardial Fat Tissue', 'timeFrame': 'On admission', 'description': 'Epicardial Fat Tissue by cardiac color Doppler ultrasound'}, {'measure': 'Cardiac Function', 'timeFrame': 'On admission', 'description': 'Left ventricular diastolic function and right ventricular systolic function by cardiac color Doppler ultrasound'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Epicardial Adipose tissue', 'Cardiac Function'], 'conditions': ['Heart Failure With Preserved Ejection Fraction']}, 'descriptionModule': {'briefSummary': 'Heart failure with preserved ejection fraction (HFpEF) refers to a group of symptoms and signs of heart failure, normal or near-normal left ventricular systolic function (EF\\>50%), and ventricular muscle diastolic dysfunction and A clinical syndrome characterized by decreased compliance and increased stiffness. The pathogenesis of HFpEF is related to impaired lipid metabolism and inflammation. Epicardial adipose tissue (Epicardial Adipose tissue, EAT) is a kind of visceral adipose tissue. Related studies have shown that extracardiac Membrane fat is related to inflammation markers, cardiometabolic risk and cardiovascular disease.However, there is still no research investigating the the relationship between epicardial fat thickness and Cardiac Function in HFpEF patients.', 'detailedDescription': 'Heart failure with preserved ejection fraction (HFpEF) refers to a group of symptoms and signs of heart failure, normal or near-normal left ventricular systolic function (EF\\>50%), and ventricular muscle diastolic dysfunction and A clinical syndrome characterized by decreased compliance and increased stiffness. The pathogenesis of HFpEF is related to impaired lipid metabolism and inflammation. Epicardial adipose tissue (Epicardial Adipose tissue, EAT) is a kind of visceral adipose tissue, which is composed of adipose tissue deposited between the myocardium and the visceral layer of the pericardium. It is closely adjacent to the coronary arteries and myocardium. Related studies have shown that extracardiac Membrane fat is related to inflammation markers, cardiometabolic risk and cardiovascular disease.However, there is still no research investigating the the relationship between epicardial fat thickness and Cardiac Function in HFpEF patients. This study intends to observe the relationship between epicardial fat thickness and left and right functions in patients with HFpEF, and evaluate whether epicardial fat thickness can be used as an indicator of left and right dysfunction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Heart failure patients with preserved ejection fraction (HFpEF)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult aged \\>=18years old;\n* Diagnosed with HFpEF.\n\nDiagnostic criteria including:\n\n1. left ventricular ejection fraction ≥50%；\n2. with the symptoms and/or signs of heart failure；\n3. BNP≥35 pg/mL and/or NTproBNP≥125 pg/mL；\n4. at least one additional criterion: relevant structural heart disease(LVH and/or LAE) or diastolic dysfunction\n\nExclusion Criteria:\n\n* LVEF less than 45% at any time;\n* Severe liver failure;\n* Primary pulmonary hypertension;\n* Age \\<18 years old.'}, 'identificationModule': {'nctId': 'NCT05068934', 'briefTitle': 'The Relationship Between Epicardial Fat Tissue and Cardiac Function in HFpEF Patients', 'organization': {'class': 'OTHER', 'fullName': 'Chongqing Medical University'}, 'officialTitle': 'The Relationship Between Epicardial Fat Tissue and Cardiac Function in HFpEF', 'orgStudyIdInfo': {'id': '2020-09'}}, 'contactsLocationsModule': {'locations': [{'city': 'Chongqing', 'country': 'China', 'facility': 'The First Affiliated Hospital of Chongqing Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'overallOfficials': [{'name': 'Dongying Zhang, doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'First Affiliated Hospital of Chongqing Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dongying Zhang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Dongying Zhang', 'investigatorFullName': 'Dongying Zhang', 'investigatorAffiliation': 'Chongqing Medical University'}}}}