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

Last updated: October 6, 2021
Sponsor: Hongchang Guo
Overall Status: Active - Recruiting

Phase

4

Condition

Cardiac Surgery

Diabetes Mellitus, Type 2

Diabetes Prevention

Treatment

N/A

Clinical Study ID

NCT04340908
AZ-SGLT2i
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 requiringthoracotomy).
  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

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 investigationalmedicinal product within the previous 30 days.
  7. Any other reason considered by a study physician to be inappropriate for inclusion.

Study Design

Total Participants: 500
Study Start date:
January 01, 2021
Estimated Completion Date:
June 01, 2023

Connect with a study center

  • Beijing Anzhen Hospital, Capital Mediacal University

    Beijing, Beijing 100000
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.