Completed

Perioperative Dapagliflozin for Improved Cardiac Surgery Outcomes in Type 2 Diabetes Patients

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Study Aim

This study aims to evaluate the effects of Dapagliflozin on heart surgery outcomes in patients with type 2 diabetes, specifically focusing on changes in high sensitive cardiac troponin-I levels.

What is being tested

Dapagliflozin

Drug
Who is being recruted

Diabetes Mellitus+3

+ Diabetes Mellitus, Type 2

+ Endocrine System Diseases

Over 18 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: November 2022
See protocol details

Summary

Principal SponsorChina National Center for Cardiovascular Diseases
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 11, 2022

Actual date on which the first participant was enrolled.

Sodium-Glucose Cotransporter 2 Inhibitors, such as dapagliflozin, are commonly used for treating type 2 diabetes. Recent findings suggest that these inhibitors not only lower blood sugar but also protect the heart and kidneys, improving patients' quality of life significantly. However, patients with type 2 diabetes often have poorer outcomes after heart surgery compared to those without diabetes. This study explores whether using dapagliflozin around the time of surgery can improve post-surgery outcomes in type 2 diabetes patients undergoing heart surgery. This is a randomized controlled trial where participants receive dapagliflozin before and after surgery. The study measures the effects of dapagliflozin by monitoring high sensitive cardiac troponin-I levels, a protein that indicates heart damage. The primary goal is to determine if dapagliflozin can reduce heart damage associated with heart surgery in type 2 diabetes patients.

Official TitleEffects of Perioperative Dapagliflozin on Type 2 Diabetic Patients Undergoing Cardiac Surgery
NCT05621551
Principal SponsorChina National Center for Cardiovascular Diseases
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

178 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

4 inclusion criteria required to participate
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
9 exclusion criteria prevent from participating
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
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Dapagliflozin 10 mg

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

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, ChinaOpen 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 in Google Maps
CompletedOne Study Center