Dapagliflozin Therapy In Cardiac Surgery

NCT05621551 | Completed Phase 4 DMC

• 1 other identifier: 2021-1437
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

SGLT2 inhibitors; Cardiac Surgery; Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Hs-Troponin-I

  high sensitive cardiac troponin-I

  within 2 days after surgery

Secondary Outcomes (12)

• Renal function

  within 5 days after surgery

• NT-proBNP

  within 5 days after surgery

• Postoperative atrial fibrillation

  within 5 days after surgery

• Perioperative myocardial infarction

  In-hospital time, an average of 2 weeks

• cardiac systolic function

  within 5 days after surgery

Other Outcomes (3)

• Safety Outcome

  In-hospital time, an average of 2 weeks

• ICU readmission

  In-hospital time, an average of 2 weeks

• Major adverse cardiac cerebrovascular events and its individual components

  30 days

Study Arms (2)

Dapagliflozin

EXPERIMENTAL

Dapagliflozin 10 mg

Drug: Dapagliflozin

Standard of care

NO INTERVENTION

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

Interventions

Dapagliflozin 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.

Dapagliflozin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years at screening
• Scheduled for cardiac surgery (on-pump coronary artery bypass grafting, aortic valve replacement, or a combination of both)
• Diagnosis of Type 2 Diabetes
• Provision of signed informed consent prior to any study specific procedures

You may not qualify if:

• Emergency surgery and non-primary surgery
• Moderate and severe dehydration; systolic pressure≤90mmHg; unstable haemodynamics
• History of diabetic ketoacidosis; type 1 diabetes mellitus
• Receiving therapy with an SGLT2 inhibitor within 4 weeks prior to enrolment
• Known allergy or hypersensitivity to dapagliflozin or other SGLT-2 inhibitors
• 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
• Serious hepatic disease
• Women who are pregnant, nursing, or who plan to become pregnant while in the trial
• Currently enrolled in another investigational drug study, or less than 30 days

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

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, 100037, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Zhe Zheng, MD,PhD

  Fuwai Hospital, Chinese Academy of Medical Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2022
• First Posted: November 18, 2022
• Study Start: November 11, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2025
• Last Updated: July 15, 2025

Record last verified: 2025-07

Locations

CN (1)