Dapagliflozin Therapy In Cardiac Surgery

NCT ID: NCT05621551

Last Updated: 2025-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 178 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-11
• Study Completion Date: 2025-06-01

Brief Summary

This randomized controlled trial is to assess the effects of perioperative dapagliflozin on type 2 diabetic patients undergoing cardiac surgery

Detailed Description

Sodium-Glucose Cotransporter 2 Inhibitor(SGLT2i) including dapagliflozin are widely used in the clinical treatment of type 2 diabetes mellitus(T2DM). In recent studies, SGLT2i were found to not only reduce blood glucose but also protect the heart and kidney, which can significantly reduce cardiovascular events, delay the progression of renal failure, greatly improve the quality of life of patients. Patients with T2DM have poorer cardiac surgery outcomes compared with non-diabetics. Based on the promising pharmacological profile of dapagliflozin, we hypothesize that perioperative dapagliflozin therapy would improve postoperative outcomes among patients undergoing cardiac surgery with T2DM. This randomized controlled trial is to assess the effects of perioperative dapagliflozin on type 2 diabetic patients undergoing cardiac surgery

Conditions

Diabetes Mellitus, Type 2; Cardiac Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Dapagliflozin

Dapagliflozin 10 mg

Group Type: EXPERIMENTAL

Dapagliflozin

Intervention Type: DRUG

The patients is required to receive dapagliflozin(10mg, q.d.) at least for 3 days until 24 hours before the surgery. Then dapagliflozin will be discontinued and recovered as soon as the patient is able to take oral diet postoperatively. Dapagliflozin wil be ceased five days after surgery.

Standard of care

Standard care treatment of diabetes patients during perioperative cardiac surgery in our center

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Dapagliflozin

The patients is required to receive dapagliflozin(10mg, q.d.) at least for 3 days until 24 hours before the surgery. Then dapagliflozin will be discontinued and recovered as soon as the patient is able to take oral diet postoperatively. Dapagliflozin wil be ceased five days after surgery.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 18 years at screening

2. Scheduled for cardiac surgery (on-pump coronary artery bypass grafting, aortic valve replacement, or a combination of both)

3. Diagnosis of Type 2 Diabetes

4. Provision of signed informed consent prior to any study specific procedures

Exclusion Criteria

1. Emergency surgery and non-primary surgery

2. Moderate and severe dehydration; systolic pressure≤90mmHg; unstable haemodynamics

3. History of diabetic ketoacidosis; type 1 diabetes mellitus

4. Receiving therapy with an SGLT2 inhibitor within 4 weeks prior to enrolment

5. Known allergy or hypersensitivity to dapagliflozin or other SGLT-2 inhibitors

6. Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2 or requiring dialysis; unstable or rapidly progressing renal disease at the time of randomisation

7. Serious hepatic disease

8. Women who are pregnant, nursing, or who plan to become pregnant while in the trial

9. Currently enrolled in another investigational drug study, or less than 30 days

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China National Center for Cardiovascular Diseases

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhe Zheng, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Fuwai Hospital, Chinese Academy of Medical Science

Locations

National Clinical Research Center for Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

2021-1437

Identifier Type: -

Identifier Source: org_study_id