Dapagliflozin Therapy In Cardiac Surgery

Phase 4

Completed

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

• Registration Number: NCT05621551
• Lead Sponsor: China National Center for Cardiovascular Diseases

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

Study Timeline

• Study First Submitted: 2022-11-04
• Study First Submitted QC: 2022-11-10
• Study Start: 2022-11-11
• Study First Posted: 2022-11-18
• Primary Completion: 2024-06-01
• Study Completion: 2025-06-01
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-09
• Last Update Posted: 2025-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 178

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dapagliflozin	Dapagliflozin	Dapagliflozin 10 mg

Primary Outcome Measures

Name	Time	Method
Hs-Troponin-I	within 2 days after surgery	high sensitive cardiac troponin-I

Secondary Outcome Measures

Name	Time	Method
Renal function	within 5 days after surgery	Acute kidney injury determined by creatinine changes and the need for renal replacement therapy, along with creatinine changes and the need for renal replacement therapy themselves.
ICU stay	an average of 3 days	ICU Stay was defined as the duration (in days) of initial postoperative stay in the intensive care unit following cardiac surgery.
NT-proBNP	within 5 days after surgery	N-terminal prohormone of brain natriuretic peptide
Postoperative atrial fibrillation	within 5 days after surgery	In this study, postoperative AF was defined as occurrence of the arrhythmia within the first 5 days after cardiac surgery. AF was considered to be present when an irregular rhythm was detected in the absence of P waves and/or presence an f wave
Perioperative myocardial infarction	In-hospital time, an average of 2 weeks	Perioperative myocardial infarction was defined as an elevation in cardiac troponin accompanied by evidence of ischemia from ECG, angiographic, or imaging findings.
cardiac systolic function	within 5 days after surgery	Improvement in either left ventricular ejection fraction or left ventricular end-systolic volume, as measured by echocardiography.
cardiac diastolic function	within 5 days after surgery	Improvement in either E/e' ratio or left ventricular end-diastolic volume, as measured by echocardiography.
Inflammatory biomarkers	within 5 days after surgery	high-sensitivity C-reactive protein, interleukin-1β, interleukin-6, interleukin-8, and tumor necrosis factor-α
Abnormal blood potassium concentration	within 5 days after surgery	blood potassium concentration\<3.5mmol/L or \>5.5mmol/L
Hs-Troponin-I	within 5 days after surgery
postoperative blood glucose level	within 5 days after surgery
Length of in-hospital time	an average of 2 weeks	Length of in-hospital time was defined as the total number of days from the date of surgery to the date of hospital discharge.

Trial Locations

Locations (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, China