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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04340908
• Other study ID #: AZ-SGLT2i
• Status: Recruiting
• Phase: Phase 4
• Start date: January 1, 2021
• Est. completion date: June 1, 2023

Study information

• Verified date: October 2021
• Source: Beijing Anzhen Hospital
• Contact: Wei, M.D.
• Phone: +86 19800367660
• Email: weizhipeng[@]outlook.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Surgery
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Dapagliflozin 10 MG
10 mg tablet, oral, once daily, 1-year treatment, postoperation
• Placebos
matching placebo tablet, oral, once daily, 1-year treatment, postoperation

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital, Capital Mediacal University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Hongchang Guo

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in mean EF% between the treatment and control study arms	Echocardiography is used to assess cardiac function.	2 year
Primary	Difference in NTproBNP between the treatment and control study arms	NT-proBNP is used to assess cardiac function.	2 year
Secondary	All-cause postoperative mortality	All-cause mortality identified during two years follow-up.	2 year
Secondary	Rehospitalization for cardiovascular causes	Rehospitalization due to cardiovascular diseases during two years follow-up.	2 year
Secondary	Serious postoperative infection	Including postoperative sternal dehiscence, external genital infections, etc.	2 year
Secondary	Acute postoperative kidney injury	Acute postoperative kidney injury requiring renal replacement therapy	2 year
Secondary	Hypoglycemia	Identified using ICD9 and ICD10 codes and reported as rates.	2 year
Secondary	Duration of Hospitalization	Days from date of surgery to hospital discharge.	2 year
Secondary	Diabetic ketoacidosis	Identified using ICD9 and ICD10 codes and reported as rates.	2 year
Secondary	Lactic acidosis	Identified using ICD9 and ICD10 codes and reported as rates.	2 year
Secondary	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