Dapagliflozin Therapy In Cardiac Surgery

Sponsor

China National Center for Cardiovascular Diseases (Other)

Overall Status

Recruiting

CT.gov ID

NCT05621551

Collaborator

(none)

178

Enrollment

Location

Arms

7.6

Anticipated Duration (Months)

23.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2 Cardiac Surgery	Drug: Dapagliflozin	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

178 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effects of Perioperative Dapagliflozin on Type 2 Diabetic Patients Undergoing Cardiac Surgery

Anticipated Study Start Date :

Nov 11, 2022

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dapagliflozin Dapagliflozin 10 mg	Drug: 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.
No Intervention: Standard of care Standard care treatment of diabetes patients during perioperative cardiac surgery in our center

Arm

Intervention/Treatment

Experimental: Dapagliflozin

Dapagliflozin 10 mg

Drug: 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.

No Intervention: Standard of care

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

Outcome Measures

Primary Outcome Measures

Hs-Troponin-I [within 2 days after surgery]
high sensitive cardiac troponin-I

Secondary Outcome Measures

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
cardiac function [within 5 days after surgery]
Echocardiography is used to assess cardiac function
Renal function [within 5 days after surgery]
Change of creatinine values, need for renal replacement therapy
Abnormal blood potassium concentration [within 5 days after surgery]
blood potassium concentration<3.5mmol/L or >5.5mmol/L
postoperative blood glucose level [within 5 days after surgery]
hs-C-reactive protein [within 5 days after surgery]
Hs-Troponin-I [within 5 days after surgery]

Other Outcome Measures

Safety Outcome [In-hospital time, an average of 2 weeks]
Number of Adverse Events, Serious Adverse Events, Diabetic ketoacidosis, Severe hypoglycemic events, hypovolemia, urogenital tract infection
Major adverse cardiac cerebrovascular events [30 days]
Exploratory endpoints
all-cause mortality [30 days]
Exploratory endpoints
Incision infection [In-hospital time, an average of 2 weeks]
Exploratory endpoints
ICU readmission [In-hospital time, an average of 2 weeks]
Exploratory endpoints
ICU stay [Length of ICU stay after surgery，an average of 3 days]
Exploratory endpoints
Length of in-hospital time [In-hospital time, an average of 2 weeks]
Exploratory endpoints

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age ≥ 18 years at screening
Scheduled for cardiac surgery
Diagnosis of Type 2 Diabetes
Provision of signed informed consent prior to any study specific procedures

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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	100037