Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-26 @ 1:23 AM
Study NCT ID:
NCT05816733
Status:
UNKNOWN
Last Update Posted:
2023-11-29
First Post:
2023-04-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dapagliflozin Evaluation on Atrial Fibrillation Patients Followed Cox Maze IV Procedure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C529054', 'term': 'dapagliflozin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 348}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-08-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-23', 'studyFirstSubmitDate': '2023-04-02', 'studyFirstSubmitQcDate': '2023-04-16', 'lastUpdatePostDateStruct': {'date': '2023-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of atrial fibrillation recurrence', 'timeFrame': 'half of one year post operative'}], 'secondaryOutcomes': [{'measure': 'Rate of atrial fibrillation recurrence', 'timeFrame': 'one year post operative'}, {'measure': 'Cardiovascular complex adverse events', 'timeFrame': 'one year post operative', 'description': 'cardiogenic death, new onset heart failure, malignant arrhythmias, stroke'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation Recurrence', 'Cox Maze IV', 'Atrial Fibrillation', 'Patients With or Without Heart Failure and Diabetes']}, 'descriptionModule': {'briefSummary': 'Atrial fibrillation (AF) is the most common arrhythmia, which leads to reduced cardiac output and promotes the occurrence of heart failure, and abnormal hemodynamic changes in the left atrium induce thrombosis, which seriously reduces the quality of life, and even leads to death. For patients who need cardiac surgery combined with the Cox-Maze IV (CMIV) surgical ablation, oral amiodarone postoperatively for three consecutive months was recommended as the preferred treatment option. However, the study found there were still 15%-35% of patients at risk of AF recurrence. Dapagliflozin, a sodium-glucose cotransporter 2 inhibitor, has been widely used for the treatment of type 2 diabetes mellitus and heart failure. Nonetheless, it remains unknown whether dapagliflozin can improve the recurrence of AF and reduces adverse cardiovascular events for patients who need CMIV ablation, and whether it can be routinely used for AF patients without diabetes or heart failure. Therefore, this study aims to explore the effect of postoperative oral dapagliflozin on the recurrence of AF after CMIV.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years\n* Patients with persistent or long-term persistent atrial fibrillation who need isolated surgical Cox-Maze IV procedure\n* Patients who need cardiac surgery combined with Cox-Maze IV procedure\n* Patients who have the ability and willingness to abide by all the subsequent reviews and requirements\n* Sign the informed consent\n\nExclusion Criteria:\n\n* Dapagliflozin allergy\n* Hyperthyroidism\n* Patients with acute myocardial infarction, cerebral apoplexy, and other vascular diseases during the past 6 months\n* Patients who received heart surgery within the last 3 months\n* eGFR\\<45ml/min\n* History of oral SGLT2i\n* Estimated survival period \\< 12 months\n* Pregnant and lactating women\n* Left atrial diameter \\> 65 mm\n* Refusing to sign the informed consent'}, 'identificationModule': {'nctId': 'NCT05816733', 'acronym': 'DETAIL-CMIV', 'briefTitle': 'Dapagliflozin Evaluation on Atrial Fibrillation Patients Followed Cox Maze IV Procedure', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Anzhen Hospital'}, 'officialTitle': 'Dapagliflozin Evaluation on Atrial Fibrillation Patients Followed Cox Maze IV Procedure: Prospective Randomized Trial (DETAIL-CMIV)', 'orgStudyIdInfo': {'id': 'KS2023017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dapagliflozin group', 'description': 'Patients who will be randomized to receive dapagliflozin following the Cox-Maze IV Procedure.', 'interventionNames': ['Drug: Dapagliflozin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'Patients who will be randomized to receive placebo following the Cox-Maze IV Procedure.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Dapagliflozin', 'type': 'DRUG', 'description': 'Patients randomized in this arm will receive dapagliflozin at a target dose of 10mg once daily and routine treatment.', 'armGroupLabels': ['Dapagliflozin group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Patients randomized in this arm will receive placebo at a target dose of 10mg once daily and routine treatment.', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100029', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'zhan peng', 'role': 'CONTACT', 'email': 'anzhen0607@126.com', 'phone': '01064456776'}, {'name': 'Hua Kun', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cardiac Surgery Center No. 7', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Zhan Peng', 'role': 'CONTACT', 'email': 'anzhen0607@126.com', 'phone': '010-64456776'}, {'name': 'Xiubin Yang', 'role': 'CONTACT', 'email': 'xiubinyang@yahoo.com', 'phone': '010-64456776'}], 'overallOfficials': [{'name': 'Kun Hua', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Beijing Anzhen Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kun Hua', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Kun Hua', 'investigatorAffiliation': 'Beijing Anzhen Hospital'}}}}