Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-28 @ 4:51 PM
Study NCT ID:
NCT05053256
Status:
UNKNOWN
Last Update Posted:
2022-08-24
First Post:
2021-08-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Relationship Between Heart Function and Metabolism in HFpEF Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2023-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-23', 'studyFirstSubmitDate': '2021-08-30', 'studyFirstSubmitQcDate': '2021-09-15', 'lastUpdatePostDateStruct': {'date': '2022-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Muscle mass', 'timeFrame': 'On admission', 'description': 'The muscle mass of HFpEF patients, such as thigh muscle mass'}, {'measure': 'Blood uric acid', 'timeFrame': 'On admission', 'description': 'The blood uric acid of HFpEF patients'}, {'measure': 'Body fat content', 'timeFrame': 'On admission', 'description': 'The body fat content of HFpEF patients, such as fat percentage and visceral fat area.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Failure With Preserved Ejection Fraction']}, 'descriptionModule': {'briefSummary': 'HFpEF has gradually become the most common form of heart failure. Studies have found that metabolic abnormalities and chronic inflammation ultimately lead to HFpEF by promoting heart remodeling. However, there are few relevant studies and the mechanism is still unclear.', 'detailedDescription': 'However, heart failure with preserved ejection fraction is difficult to diagnose and treat due to its unknown pathogenesis and poor prognosis. Ventricular diastolic dysfunction and retention of left ventricular ejection fraction are important pathological features of Heart failure with preserved ejection fraction. Currently, it is widely believed to be a clinical syndrome associated with old age, women, obesity, diabetes, hypertension, atrial fibrillation, coronary heart disease, atherosclerosis, etc. However, the specific mechanism of heart failure with preserved ejection fraction caused by the above-mentioned complications is unknown. In conclusion, the investigators intend to explore the pathogenesis of heart failure with preserved ejection fraction by observing the changes of heart and body metabolism in patients with heart failure with preserved ejection fraction, and provide a basis for the diagnosis and treatment.'}, '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 ≥ 18 years old\n* Patients diagnosed with HFpEF;\n\nDiagnostic criteria including:\n\n1. LVEF 50% or higher;\n2. BNP≥35 pg/mL and/or NTproBNP≥125 pg/mL;\n3. Presence of symptoms and/or signs of heart failure;\n4. At least one additional criteria: relevant structure heart disease or diastolic dysfunction\n\nExclusion Criteria:\n\n* Severe liver failure;\n* Other causes of shortness of breath, such as severe pulmonary disease or severe ● chronic obstructive pulmonary disease;\n* Primary pulmonary hypertension.\n* Severe left valvular heart disease.\n* Long-term bedridden or unable to move autonomously\n* Age \\< 18'}, 'identificationModule': {'nctId': 'NCT05053256', 'briefTitle': 'The Relationship Between Heart Function and Metabolism in HFpEF Patients', 'organization': {'class': 'OTHER', 'fullName': 'Chongqing Medical University'}, 'officialTitle': 'The Relationship Between Heart Function and Metabolism in Heart Failure With Preserved Ejection Fraction Patients', 'orgStudyIdInfo': {'id': '2021-08-29'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HFpEF', 'description': 'Heart failure with preserved ejection fraction'}, {'label': 'HFrEF', 'description': 'Heart failure with reduced ejection fraction'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chongqing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Dongying Zhang, doctor', 'role': 'CONTACT', 'email': 'zdy.chris@qq.com', 'phone': '+8613608398395'}], 'facility': 'The First Affiliated Hospital of Chongqing Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'centralContacts': [{'name': 'Dongying Zhang, doctor', 'role': 'CONTACT', 'email': 'zdy.chris@qq.com', 'phone': '+8613608398395'}], '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'}}}}