Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-29 @ 7:58 PM
Study NCT ID:
NCT05621551
Status:
COMPLETED
Last Update Posted:
2025-07-15
First Post:
2022-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dapagliflozin Therapy In Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 178}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-09', 'studyFirstSubmitDate': '2022-11-04', 'studyFirstSubmitQcDate': '2022-11-10', 'lastUpdatePostDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Safety Outcome', 'timeFrame': 'In-hospital time, an average of 2 weeks', 'description': 'Diabetic ketoacidosis, severe hypoglycemic events, hypovolemia, urogenital tract infection, Incision infection and serious adverse events'}, {'measure': 'ICU readmission', 'timeFrame': 'In-hospital time, an average of 2 weeks', 'description': 'ICU readmission was defined as any unplanned readmission to the intensive care unit during the index hospitalization after the initial ICU discharge, regardless of cause.'}, {'measure': 'Major adverse cardiac cerebrovascular events and its individual components', 'timeFrame': '30 days', 'description': 'Major adverse cardiac cerebrovascular events composite includes all-cause mortality, myocardial infarction, stroke, and reoperation'}], 'primaryOutcomes': [{'measure': 'Hs-Troponin-I', 'timeFrame': 'within 2 days after surgery', 'description': 'high sensitive cardiac troponin-I'}], 'secondaryOutcomes': [{'measure': 'Renal function', 'timeFrame': 'within 5 days after surgery', 'description': 'Acute kidney injury determined by creatinine changes and the need for renal replacement therapy, along with creatinine changes and the need for renal replacement therapy themselves.'}, {'measure': 'NT-proBNP', 'timeFrame': 'within 5 days after surgery', 'description': 'N-terminal prohormone of brain natriuretic peptide'}, {'measure': 'Postoperative atrial fibrillation', 'timeFrame': 'within 5 days after surgery', 'description': 'In this study, postoperative AF was defined as occurrence of the arrhythmia within the first 5 days after cardiac surgery. AF was considered to be present when an irregular rhythm was detected in the absence of P waves and/or presence an f wave'}, {'measure': 'Perioperative myocardial infarction', 'timeFrame': 'In-hospital time, an average of 2 weeks', 'description': 'Perioperative myocardial infarction was defined as an elevation in cardiac troponin accompanied by evidence of ischemia from ECG, angiographic, or imaging findings.'}, {'measure': 'cardiac systolic function', 'timeFrame': 'within 5 days after surgery', 'description': 'Improvement in either left ventricular ejection fraction or left ventricular end-systolic volume, as measured by echocardiography.'}, {'measure': 'cardiac diastolic function', 'timeFrame': 'within 5 days after surgery', 'description': "Improvement in either E/e' ratio or left ventricular end-diastolic volume, as measured by echocardiography."}, {'measure': 'Abnormal blood potassium concentration', 'timeFrame': 'within 5 days after surgery', 'description': 'blood potassium concentration\\<3.5mmol/L or \\>5.5mmol/L'}, {'measure': 'postoperative blood glucose level', 'timeFrame': 'within 5 days after surgery'}, {'measure': 'Inflammatory biomarkers', 'timeFrame': 'within 5 days after surgery', 'description': 'high-sensitivity C-reactive protein, interleukin-1β, interleukin-6, interleukin-8, and tumor necrosis factor-α'}, {'measure': 'Hs-Troponin-I', 'timeFrame': 'within 5 days after surgery'}, {'measure': 'ICU stay', 'timeFrame': 'an average of 3 days', 'description': 'ICU Stay was defined as the duration (in days) of initial postoperative stay in the intensive care unit following cardiac surgery.'}, {'measure': 'Length of in-hospital time', 'timeFrame': 'an average of 2 weeks', 'description': 'Length of in-hospital time was defined as the total number of days from the date of surgery to the date of hospital discharge.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SGLT2 inhibitors', 'Cardiac Surgery', 'Diabetes Mellitus'], 'conditions': ['Diabetes Mellitus, Type 2', 'Cardiac Surgery']}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial is to assess the effects of perioperative dapagliflozin on type 2 diabetic patients undergoing cardiac surgery', 'detailedDescription': 'Sodium-Glucose Cotransporter 2 Inhibitor(SGLT2i) including dapagliflozin are widely used in the clinical treatment of type 2 diabetes mellitus(T2DM). In recent studies, SGLT2i were found to not only reduce blood glucose but also protect the heart and kidney, which can significantly reduce cardiovascular events, delay the progression of renal failure, greatly improve the quality of life of patients. Patients with T2DM have poorer cardiac surgery outcomes compared with non-diabetics. Based on the promising pharmacological profile of dapagliflozin, we hypothesize that perioperative dapagliflozin therapy would improve postoperative outcomes among patients undergoing cardiac surgery with T2DM. This randomized controlled trial is to assess the effects of perioperative dapagliflozin on type 2 diabetic patients undergoing cardiac surgery'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 18 years at screening\n2. Scheduled for cardiac surgery (on-pump coronary artery bypass grafting, aortic valve replacement, or a combination of both)\n3. Diagnosis of Type 2 Diabetes\n4. Provision of signed informed consent prior to any study specific procedures\n\nExclusion Criteria:\n\n1. Emergency surgery and non-primary surgery\n2. Moderate and severe dehydration; systolic pressure≤90mmHg; unstable haemodynamics\n3. History of diabetic ketoacidosis; type 1 diabetes mellitus\n4. Receiving therapy with an SGLT2 inhibitor within 4 weeks prior to enrolment\n5. Known allergy or hypersensitivity to dapagliflozin or other SGLT-2 inhibitors\n6. Estimated glomerular filtration rate (eGFR) \\<30 mL/min/1.73 m2 or requiring dialysis; unstable or rapidly progressing renal disease at the time of randomisation\n7. Serious hepatic disease\n8. Women who are pregnant, nursing, or who plan to become pregnant while in the trial\n9. Currently enrolled in another investigational drug study, or less than 30 days'}, 'identificationModule': {'nctId': 'NCT05621551', 'briefTitle': 'Dapagliflozin Therapy In Cardiac Surgery', 'organization': {'class': 'OTHER_GOV', 'fullName': 'China National Center for Cardiovascular Diseases'}, 'officialTitle': 'Effects of Perioperative Dapagliflozin on Type 2 Diabetic Patients Undergoing Cardiac Surgery', 'orgStudyIdInfo': {'id': '2021-1437'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dapagliflozin', 'description': 'Dapagliflozin 10 mg', 'interventionNames': ['Drug: Dapagliflozin']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of care', 'description': 'Standard care treatment of diabetes patients during perioperative cardiac surgery in our center'}], 'interventions': [{'name': 'Dapagliflozin', 'type': 'DRUG', 'description': 'The patients is required to receive dapagliflozin(10mg, q.d.) at least for 3 days until 24 hours before the surgery. Then dapagliflozin will be discontinued and recovered as soon as the patient is able to take oral diet postoperatively. Dapagliflozin wil be ceased five days after surgery.', 'armGroupLabels': ['Dapagliflozin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100037', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'National Clinical Research Center for Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Zhe Zheng, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fuwai Hospital, Chinese Academy of Medical Science'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China National Center for Cardiovascular Diseases', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}