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

Study 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.

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

Conditions
-----------------
Diabetes Mellitus, Type 2, Cardiac Surgery

Intervention / Treatment
-----------------
* Drug: Dapagliflozin 10 MG
* Drug: Placebos


Participation Criteria
=================
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 m2. 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 m2. 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Dapagliflozin 10 mg tablet | Drug: Dapagliflozin 10 MG<br>* 10 mg tablet, oral, once daily, 1-year treatment, postoperation<br>* Other names: Forxiga;|
| Placebo Comparator: Control<br>matching placebo tablet | Drug: Placebos<br>* matching placebo tablet, oral, once daily, 1-year treatment, postoperation<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in mean EF% between the treatment and control study arms | Echocardiography is used to assess cardiac function. | 2 year | 
| Difference in NTproBNP between the treatment and control study arms | NT-proBNP is used to assess cardiac function. | 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause postoperative mortality | All-cause mortality identified during two years follow-up. | 2 year | 
| Rehospitalization for cardiovascular causes | Rehospitalization due to cardiovascular diseases during two years follow-up. | 2 year | 
| Serious postoperative infection | Including postoperative sternal dehiscence, external genital infections, etc. | 2 year | 
| Acute postoperative kidney injury | Acute postoperative kidney injury requiring renal replacement therapy | 2 year | 
| Hypoglycemia | Identified using ICD9 and ICD10 codes and reported as rates. | 2 year | 
| Duration of Hospitalization | Days from date of surgery to hospital discharge. | 2 year | 
| Diabetic ketoacidosis | Identified using ICD9 and ICD10 codes and reported as rates. | 2 year | 
| Lactic acidosis | Identified using ICD9 and ICD10 codes and reported as rates. | 2 year | 
| Post operative atrial fibrillation | In this study, postoperative AF was defined as occurrence of the arrhythmia within the first 7 days after cardiac surgery. AF was considered to be present when an irregular rhythm was detected in the absence of P waves and/or an f wave was detected. | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes Mellitus, Outcome, SGLT2 inhibitors, Cardiac Surgery