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

Phase 4

• Conditions: Diabetes Mellitus, Type 2; Cardiac Surgery
• Interventions: Drug: Dapagliflozin 10 MG; Drug: Placebos

• Registration Number: NCT04340908
• Lead Sponsor: Hongchang Guo

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-02
• Study First Submitted QC: 2020-04-07
• Study First Posted: 2020-04-10
• Study Start: 2021-01-01
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-06
• Last Update Posted: 2021-10-07
• Primary Completion: 2022-06-01
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Dapagliflozin 10 MG	Dapagliflozin 10 mg tablet
Control	Placebos	matching placebo tablet

Primary Outcome Measures

Name	Time	Method
Difference in mean EF% between the treatment and control study arms	2 year	Echocardiography is used to assess cardiac function.
Difference in NTproBNP between the treatment and control study arms	2 year	NT-proBNP is used to assess cardiac function.

Secondary Outcome Measures

Name	Time	Method
Rehospitalization for cardiovascular causes	2 year	Rehospitalization due to cardiovascular diseases during two years follow-up.
All-cause postoperative mortality	2 year	All-cause mortality identified during two years follow-up.
Serious postoperative infection	2 year	Including postoperative sternal dehiscence, external genital infections, etc.
Acute postoperative kidney injury	2 year	Acute postoperative kidney injury requiring renal replacement therapy
Hypoglycemia	2 year	Identified using ICD9 and ICD10 codes and reported as rates.
Duration of Hospitalization	2 year	Days from date of surgery to hospital discharge.
Diabetic ketoacidosis	2 year	Identified using ICD9 and ICD10 codes and reported as rates.
Lactic acidosis	2 year	Identified using ICD9 and ICD10 codes and reported as rates.
Post operative atrial fibrillation	7 days	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.

Trial Locations

Locations (1)

Beijing Anzhen Hospital, Capital Mediacal University; 🇨🇳 Beijing, Beijing, China