Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-30 @ 1:13 PM
Study NCT ID:
NCT06338033
Status:
COMPLETED
Last Update Posted:
2024-03-29
First Post:
2024-03-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prognostic Study of Visceral Fat and Heart Failure With Preserved Ejection Fraction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 298}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-23', 'studyFirstSubmitDate': '2024-03-23', 'studyFirstSubmitQcDate': '2024-03-23', 'lastUpdatePostDateStruct': {'date': '2024-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Composite endpoints of all-cause mortality and rehospitalization for heart failure', 'timeFrame': 'November 30, 2023', 'description': 'Composite endpoints of all-cause mortality and rehospitalization for heart failure'}], 'primaryOutcomes': [{'measure': 'All-cause mortality', 'timeFrame': 'November 30, 2023', 'description': 'All-cause mortality'}], 'secondaryOutcomes': [{'measure': 'Rehospitalization for heart failure', 'timeFrame': 'November 30, 2023', 'description': 'Rehospitalization for heart failure'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Failure With Preserved Ejection Fraction and Visceral Fat']}, 'descriptionModule': {'briefSummary': 'Obesity and heart failure with preserved ejection fraction (HFpEF) have multiple pathologic associations that affect the prognosis of HFpEF. Chinese people are more prone to visceral obesity, resulting in varying degrees of true obesity in individuals with the same body mass index (BMI). There are no prognostic studies of VFA/BMI in the HFpEF population.', 'detailedDescription': 'A total of 298 patients with HFpEF who were hospitalized in the Department of Cardiovascular Medicine of the First Affiliated Hospital of Chongqing Medical University from September 2020 to August 2023 were included in this prospective cohort study.All patients were followed up on November 30, 2023.The primary endpoint of the study was all-cause mortality and secondary endpoints were rehospitalization for heart failure and composite endpoints of both.After a median follow-up of 564 days, a total of 30 (10.1%) patients died and 82 (27.5%) were rehospitalized for heart failure. Patients with HFpEF were categorized into two groups according to median VFA/BMI (VFA/BMI \\<5.49; VFA/BMI ≥5.49).The aim of this study was to elucidate whether VFA/BMI has prognostic value in patients with HFpEF by Kaplan-Meier survival analysis and cox regression analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Heart failure with preserved ejection fraction(HFpEF)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adule aged≥18 years old;\n* Diagnosed with HFpEF.\n\nDiagnostic criteria including:\n\n1. left ventricular ejection fraction ≥50%;\n2. with signs and/or symptoms of heart failure;\n3. Sinus rhythm：BNP≥35pg/mL and/or NT-proBNP≥125pg/mL;Atrial fibrillation rhythm：BNP≥105pg/mL and/or NT-proBNP≥365pg/mL；\n4. at least one additional criterion: relevant structural heart disease(LVH and/or LAE) or diastolic dysfunction.\n\nExclusion Criteria:\n\n* Age ≤18 years;\n* malignant tumor;\n* comorbid severe hepatic and/or renal insufficiency;\n* lost to follow-up.'}, 'identificationModule': {'nctId': 'NCT06338033', 'briefTitle': 'Prognostic Study of Visceral Fat and Heart Failure With Preserved Ejection Fraction', 'organization': {'class': 'OTHER', 'fullName': 'Chongqing Medical University'}, 'officialTitle': 'Prognostic Study of Visceral Fat and Heart Failure With Preserved Ejection Fraction', 'orgStudyIdInfo': {'id': '2024-03-23'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'VFA/BMI<5.49'}, {'label': 'VFA/BMI≥5.49'}]}, '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': 'Chongqing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Dongying Zhang', 'investigatorAffiliation': 'Chongqing Medical University'}}}}