Effects of SGLT2 Inhibitor on Type 2 Diabetic Patients Undergoing Cardiac Surgery
NCT ID: NCT04340908
Last Updated: 2021-10-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
500 participants
INTERVENTIONAL
2021-01-01
2023-06-01
Brief Summary
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SGLT2 inhibitors including dapagliflozin as a new diabetes drug can reduce heart failure hospitalization rates and overall cardiovascular mortality in patients with cardiovascular disease.
This study is to assess the impact of one year of treatment of SGLT2 inhibitors on cardiac function, postoperative complications and long-term cardiovascular mortality in diabetic patients undergoing cardiac surgery.
The investigators use echocardiography to evaluated cardiac function in diabetic patients during perioperative cardiac surgery.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment
Dapagliflozin 10 mg tablet
Dapagliflozin 10 MG
10 mg tablet, oral, once daily, 1-year treatment, postoperation
Control
matching placebo tablet
Placebos
matching placebo tablet, oral, once daily, 1-year treatment, postoperation
Interventions
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Dapagliflozin 10 MG
10 mg tablet, oral, once daily, 1-year treatment, postoperation
Placebos
matching placebo tablet, oral, once daily, 1-year treatment, postoperation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of Type 2 Diabetes.
3. Scheduled for cardiac surgery (coronary artery bypass grafting, valve replacement, ventricular assist device, cardiac transplantation, or any other surgery requiring thoracotomy).
4. eGFR ≥ 60 ml/min/1.73 m2.
5. Patients who agree to receive treatment with SGLT2 inhibitors.
6. Patients must be on current stable hemodynamic profile , without dehydration.
Exclusion Criteria
2. eGFR \< 60 ml/min/1.73 m2.
3. Unstable or rapidly progressive renal disease.
4. Hypersensitivity to dapagliflozin or any excipients.
5. Severe hepatic disease.
6. Patients who have participated in any other clinical trial of an investigational medicinal product within the previous 30 days.
7. Any other reason considered by a study physician to be inappropriate for inclusion.
18 Years
ALL
No
Sponsors
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Hongchang Guo
OTHER
Responsible Party
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Hongchang Guo
Attending doctor
Principal Investigators
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Lai, M.D.
Role: STUDY_CHAIR
Beijing Anzhen Hospital
Guo, M.D.
Role: STUDY_DIRECTOR
Beijing Anzhen Hospital
Locations
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Beijing Anzhen Hospital, Capital Mediacal University
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AZ-SGLT2i
Identifier Type: -
Identifier Source: org_study_id
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