Effects of SGLT2 Inhibitor on Type 2 Diabetic Patients Undergoing Cardiac Surgery

Patients with diabetes have poorer cardiac surgery outcomes compared with non-diabetics. Proper blood glucose management is critical to reduce the morbidity and mortality for diabetic patients after cardiac surgery.

SGLT2 inhibitors including dapagliflozin as a new diabetes drug can reduce heart failure hospitalization rates and overall cardiovascular mortality in patients with cardiovascular disease.

This study is to assess the impact of one year of treatment of SGLT2 inhibitors on cardiac function, postoperative complications and long-term cardiovascular mortality in diabetic patients undergoing cardiac surgery.

The investigators use echocardiography to evaluated cardiac function in diabetic patients during perioperative cardiac surgery.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 2; Cardiac Surgery
• Intervention / Treatment: Drug: Dapagliflozin 10 MG; Drug: Placebos

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Wei, M.D.; Phone Number: +86 19800367660; Email: weizhipeng@outlook.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100000
      • Recruiting
      • Beijing Anzhen Hospital, Capital Mediacal University
      • Contact: Wei, M.D.; Email: weizhipeng@outlook.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age ≥ 18 years old at index date.
2. Diagnosis of Type 2 Diabetes.
3. Scheduled for cardiac surgery (coronary artery bypass grafting, valve replacement, ventricular assist device, cardiac transplantation, or any other surgery requiring thoracotomy).
4. eGFR ≥ 60 ml/min/1.73 m2.
5. Patients who agree to receive treatment with SGLT2 inhibitors.
6. Patients must be on current stable hemodynamic profile , without dehydration.

Exclusion Criteria:

1. Diagnosis of Type 1 Diabetes.
2. eGFR < 60 ml/min/1.73 m2.
3. Unstable or rapidly progressive renal disease.
4. Hypersensitivity to dapagliflozin or any excipients.
5. Severe hepatic disease.
6. Patients who have participated in any other clinical trial of an investigational medicinal product within the previous 30 days.
7. Any other reason considered by a study physician to be inappropriate for inclusion.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Dapagliflozin 10 mg tablet	Drug: Dapagliflozin 10 MG; 10 mg tablet, oral, once daily, 1-year treatment, postoperation; Other Names: Forxiga
Placebo Comparator: Control; matching placebo tablet	Drug: Placebos; matching placebo tablet, oral, once daily, 1-year treatment, postoperation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in mean EF% between the treatment and control study arms	Echocardiography is used to assess cardiac function.	2 year
Difference in NTproBNP between the treatment and control study arms	NT-proBNP is used to assess cardiac function.	2 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause postoperative mortality	All-cause mortality identified during two years follow-up.	2 year
Rehospitalization for cardiovascular causes	Rehospitalization due to cardiovascular diseases during two years follow-up.	2 year
Serious postoperative infection	Including postoperative sternal dehiscence, external genital infections, etc.	2 year
Acute postoperative kidney injury	Acute postoperative kidney injury requiring renal replacement therapy	2 year
Hypoglycemia	Identified using ICD9 and ICD10 codes and reported as rates.	2 year
Duration of Hospitalization	Days from date of surgery to hospital discharge.	2 year
Diabetic ketoacidosis	Identified using ICD9 and ICD10 codes and reported as rates.	2 year
Lactic acidosis	Identified using ICD9 and ICD10 codes and reported as rates.	2 year
Post operative atrial fibrillation	In this study, postoperative AF was defined as occurrence of the arrhythmia within the first 7 days after cardiac surgery. AF was considered to be present when an irregular rhythm was detected in the absence of P waves and/or an f wave was detected.	7 days

Collaborators and Investigators

• Sponsor: Hongchang Guo
• Investigators: Study Chair: Lai, M.D., Beijing Anzhen Hospital; Study Director: Guo, M.D., Beijing Anzhen Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: April 2, 2020
• First Submitted That Met QC Criteria: April 7, 2020
• First Posted (Actual): April 10, 2020

Study Record Updates

• Last Update Posted (Actual): October 7, 2021
• Last Update Submitted That Met QC Criteria: October 6, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Diabetes Mellitus; Cardiac Surgery; Outcome; SGLT2 inhibitors
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Sodium-Glucose Transporter 2 Inhibitors; Dapagliflozin
• Other Study ID Numbers: AZ-SGLT2i

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No