Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 10:15 PM
Study NCT ID:
NCT06092658
Status:
COMPLETED
Last Update Posted:
2023-10-23
First Post:
2023-08-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cohort Study of Chronic Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2022-07-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-19', 'studyFirstSubmitDate': '2023-08-21', 'studyFirstSubmitQcDate': '2023-10-19', 'lastUpdatePostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'echocardiogram', 'timeFrame': 'Follow up will be conducted at baseline, 6 months, 12 months, and 36 months', 'description': 'ejection fraction,Consider heart failure when the ejection fraction is less than 50%'}, {'measure': 'cardiac marker', 'timeFrame': 'Follow up will be conducted at baseline, 6 months, 12 months, and 36 months', 'description': 'CK，CK-MB，cTnT，cTnI，Mb'}, {'measure': 'serum biochemical indicators', 'timeFrame': 'Follow up will be conducted at baseline, 6 months, 12 months, and 36 months', 'description': 'HDL-cholesterol, mg/dL，LDL-cholesterol, mg/dL，Total cholesterol, mg/dL，Triglycerides, mg/dL'}], 'secondaryOutcomes': [{'measure': 'Thyroid Function', 'timeFrame': 'Follow up will be conducted at baseline, 6 months, 12 months, and 36 months', 'description': 'thyroid hormone,Thyroid hormone blood testing: This is the most commonly used method to measure thyroid hormone levels in the blood. Common thyroid hormone indicators include thyroxine, free thyroxine, triiodothyronine, and free triiodothyronine.'}, {'measure': 'Coagulation function indicators', 'timeFrame': 'Follow up will be conducted at baseline, 6 months, 12 months, and 36 months', 'description': 'D-Dimer'}, {'measure': 'Blood routine', 'timeFrame': 'Follow up will be conducted at baseline, 6 months, 12 months, and 36 months', 'description': 'RBC'}, {'measure': 'Blood routine', 'timeFrame': 'Follow up will be conducted at baseline, 6 months, 12 months, and 36 months', 'description': 'WBC'}, {'measure': 'Blood routine', 'timeFrame': 'Follow up will be conducted at baseline, 6 months, 12 months, and 36 months', 'description': 'PLT'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Analyze Etiology, Comorbidities, Clinical Characteristics']}, 'descriptionModule': {'briefSummary': 'The purpose is to understand the clinical characteristics of chronic heart failure as soon as possible, analyze the etiology, comorbidities, clinical characteristics, and treatment of heart failure patients, observe the gap between real-world clinical practice and guideline recommendations, and provide reference for the improvement of heart failure prevention and treatment in China.', 'detailedDescription': 'Inclusion criteria:\n\n1. Accompanied by difficulty breathing, fatigue, or decreased activity tolerance;\n2. Signs of fluid retention (pulmonary congestion and peripheral edema);\n3. Echocardiography shows abnormalities in cardiac structure and/or function;\n4. Elevated levels of natriuretic peptide: B-type natriuretic peptide (BNP)\\>35 ng/L and/or N-terminal B-type proBNP (NT proBNP)\\>125 ng/L.\n5. HF hospitalization recorded within the previous 12 months\n\nExclusion criteria:\n\n1. Concomitant severe liver function, renal failure, or other severe system dysfunction\n2. Poor compliance, inability to obtain information, or voluntary refusal to participate in this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Accompanied by difficulty breathing, fatigue, or decreased activity tolerance;\n2. Signs of fluid retention (pulmonary congestion and peripheral edema);\n3. Echocardiography shows abnormalities in cardiac structure and/or function;\n4. Elevated levels of natriuretic peptide: B-type natriuretic peptide (BNP)\\>35 ng/L and/or N-terminal B-type proBNP (NT proBNP)\\>125 ng/L.\n\nExclusion Criteria:\n\n1. Concomitant severe liver function, renal failure, or other severe system dysfunction\n2. Poor compliance, inability to obtain information, or voluntary refusal to participate in this study.'}, 'identificationModule': {'nctId': 'NCT06092658', 'briefTitle': 'Cohort Study of Chronic Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Xinjiang Medical University'}, 'officialTitle': 'Cohort Study of Chronic Heart Failure', 'orgStudyIdInfo': {'id': '202207-019'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'No Intervention', 'description': 'No Intervention', 'interventionNames': ['Other: No Intervention']}], 'interventions': [{'name': 'No Intervention', 'type': 'OTHER', 'description': 'no intervention', 'armGroupLabels': ['No Intervention']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'undecided'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xiang Xie', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Xiang Xie', 'investigatorAffiliation': 'Xinjiang Medical University'}}}}