Effects of SGLT2 Inhibitor on Type 2 Diabetic Patients Undergoing Cardiac Surgery
Overview
- Phase
- Phase 4
- Intervention
- Dapagliflozin 10 MG
- Conditions
- Diabetes Mellitus, Type 2
- Sponsor
- Hongchang Guo
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Difference in mean EF% between the treatment and control study arms
- Last Updated
- 4 years ago
Overview
Brief Summary
Patients with diabetes have poorer cardiac surgery outcomes compared with non-diabetics. Proper blood glucose management is critical to reduce the morbidity and mortality for diabetic patients after cardiac surgery.
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.
Investigators
Hongchang Guo
Attending doctor
Beijing Anzhen Hospital
Eligibility Criteria
Inclusion Criteria
- •Age ≥ 18 years old at index date.
- •Diagnosis of Type 2 Diabetes.
- •Scheduled for cardiac surgery (coronary artery bypass grafting, valve replacement, ventricular assist device, cardiac transplantation, or any other surgery requiring thoracotomy).
- •eGFR ≥ 60 ml/min/1.73 m
- •Patients who agree to receive treatment with SGLT2 inhibitors.
- •Patients must be on current stable hemodynamic profile , without dehydration.
Exclusion Criteria
- •Diagnosis of Type 1 Diabetes.
- •eGFR \< 60 ml/min/1.73 m
- •Unstable or rapidly progressive renal disease.
- •Hypersensitivity to dapagliflozin or any excipients.
- •Severe hepatic disease.
- •Patients who have participated in any other clinical trial of an investigational medicinal product within the previous 30 days.
- •Any other reason considered by a study physician to be inappropriate for inclusion.
Arms & Interventions
Treatment
Dapagliflozin 10 mg tablet
Intervention: Dapagliflozin 10 MG
Control
matching placebo tablet
Intervention: Placebos
Outcomes
Primary Outcomes
Difference in mean EF% between the treatment and control study arms
Time Frame: 2 year
Echocardiography is used to assess cardiac function.
Difference in NTproBNP between the treatment and control study arms
Time Frame: 2 year
NT-proBNP is used to assess cardiac function.
Secondary Outcomes
- Hypoglycemia(2 year)
- Rehospitalization for cardiovascular causes(2 year)
- Acute postoperative kidney injury(2 year)
- Serious postoperative infection(2 year)
- All-cause postoperative mortality(2 year)
- Duration of Hospitalization(2 year)
- Diabetic ketoacidosis(2 year)
- Lactic acidosis(2 year)
- Post operative atrial fibrillation(7 days)