Overview

Effects of SGLT2 Inhibitor on Type 2 Diabetic Patients Undergoing Cardiac Surgery

Status:
Recruiting
Trial end date:
2023-06-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hongchang Guo
Treatments:
2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol
Dapagliflozin
Sodium-Glucose Transporter 2 Inhibitors
Criteria
Inclusion Criteria:

1. Age ≥ 18 years old at index date.

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:

1. Diagnosis of Type 1 Diabetes.

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.