Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-26 @ 9:55 PM
Study NCT ID:
NCT06068166
Status:
COMPLETED
Last Update Posted:
2024-03-13
First Post:
2023-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thoracic Epidural Anesthesia Reduces Mortality and Rehospitalization for Patients With Heart Failure With Reduced Ejection Fraction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013662', 'term': 'Tea'}], 'ancestors': [{'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D001628', 'term': 'Beverages'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1840}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-12', 'studyFirstSubmitDate': '2023-09-28', 'studyFirstSubmitQcDate': '2023-09-28', 'lastUpdatePostDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of heart failure mortality in the patients with HFrEF', 'timeFrame': '8.5 years', 'description': 'Rate of heart failure mortality in the patients with HFrEF'}], 'secondaryOutcomes': [{'measure': 'Rate of heart failure rehospitalization in the patients with HFrEF', 'timeFrame': '8.5 years', 'description': 'Rate of heart failure rehospitalization in the patients with HFrEF'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Failure With Reduced Ejection Fraction', 'Thoracic Epidural Anesthesia']}, 'descriptionModule': {'briefSummary': 'Despite significant scientific breakthrough in management, patients with heart failure with reduced ejection fraction (HFrEF) remain high morbidity and mortality, with a 5-year survival rate of 25% after hospitalization for HFrEF. The autonomic nervous system (ANS), particularly the sympathetic nervous system (SNS), plays a critical compensatory role in maintaining cardiovascular homeostasis in the failing heart. This is critical given the huge unmet need for novel treatment strategies for HFrEF.\n\nThoracic epidural anesthesia (TEA), the infusion of anesthetic agents (eg, lidocaine or ropivacaine) into the epidural space, is used to achieve sympathetic block at the T1 to T4 levels in thoracic and abdominal surgical procedures. Since 1995, Professor Liu Fengqi has pioneered the use of TEA to treat end-stage HFrEF and achieved surprising results. TEA could reduce the enlarged heart cavity, halt and reverse cardiac remodeling, and improve cardiac systolic and diastolic function. Currently, thousands of HFrEF patients have received TEA procedure. However, it is unclear whether TEA could positively impact the clinical outcomes of patients with HFrEF.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The present study was a retrospective, observational, matched case-control study of 1,840 consecutive inpatients, in New York Heart Association functional class II-IV with a left ventricular ejection fraction (LVEF) ≤40%, who were hospitalized from July 2013 to August 2019.\n\nExclusion Criteria:\n\n* Patients were excluded because of insufficient patient information, refusal to participate, or loss to follow-up by telephone. In patients with multiple hospitalizations during the time period, the first hospitalization was utilized in the analysis.'}, 'identificationModule': {'nctId': 'NCT06068166', 'briefTitle': 'Thoracic Epidural Anesthesia Reduces Mortality and Rehospitalization for Patients With Heart Failure With Reduced Ejection Fraction', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Harbin Medical University'}, 'officialTitle': 'Thoracic Epidural Anesthesia Reduces Mortality and Rehospitalization for Patients With Heart Failure With Reduced Ejection Fraction：a Retrospective Matched Case-control Study', 'orgStudyIdInfo': {'id': 'TEA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GDMT plus TEA', 'description': 'The patients received maximally tolerated guideline-directed medical therapy (GDMT) plus TEA.\n\nThoracic epidural anesthesia (TEA), the infusion of anesthetic agents (eg, lidocaine or ropivacaine) into the epidural space, is used to achieve sympathetic block at the T1 to T4 levels in thoracic and abdominal surgical procedures.', 'interventionNames': ['Combination Product: TEA plus GDMT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'GDMT', 'description': 'The patients received maximally tolerated GDMT.', 'interventionNames': ['Drug: GDMT']}], 'interventions': [{'name': 'TEA plus GDMT', 'type': 'COMBINATION_PRODUCT', 'description': 'Thoracic epidural anesthesia (TEA), the infusion of anesthetic agents (eg, lidocaine or ropivacaine) into the epidural space, is used to achieve sympathetic block at the T1 to T4 levels in thoracic and abdominal surgical procedures. Since 1995, Professor Liu Fengqi has pioneered the use of TEA to treat end-stage HFrEF and achieved surprising results. TEA could reduce the enlarged heart cavity, halt and reverse cardiac remodeling, and improve cardiac systolic and diastolic function. Currently, thousands of HFrEF patients have received TEA procedure. All the patients received maximally tolerated guideline-directed medical therapy (GDMT).', 'armGroupLabels': ['GDMT plus TEA']}, {'name': 'GDMT', 'type': 'DRUG', 'description': 'All the patients received maximally tolerated guideline-directed medical therapy (GDMT) alone.', 'armGroupLabels': ['GDMT']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital of Harbin Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}