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

  • STATUS
    Recruiting
  • End date
    Jun 1, 2023
  • participants needed
    500
  • sponsor
    Hongchang Guo
Updated on 24 January 2021
diabetes
cardiovascular disease
bypass graft
postoperative complication
thoracotomy
sglt2 inhibitor
heart transplantation
dapagliflozin
sglt2

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.

Details
Condition NIDDM, Thoracic Surgery, heart surgery, Diabetes Mellitus, Type 2, Cardiac Surgery, Diabetes Mellitus Type 2, type 2 diabetes mellitus, cardiac operation, type 2 diabetes, type ii diabetes, noninsulin-dependent diabetes mellitus, diabetes type 2
Treatment placebos, Dapagliflozin 10 mg
Clinical Study IdentifierNCT04340908
SponsorHongchang Guo
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Diabetes Mellitus, Type 2 or heart surgery or Thoracic Surgery or Diabetes Mellitus Type 2 or NIDDM or Cardiac Surgery?
Do you have any of these conditions: Diabetes Mellitus Type 2 or diabetes type 2 or type 2 diabetes mellitus or NIDDM or cardiac operation or Diabetes Mellitus, Type 2 or noninsulin-depen...?
Age 18 years old at index date
Diagnosis of Type 2 Diabetes
Scheduled for cardiac surgery (coronary artery bypass grafting, valve replacement, ventricular assist device, cardiac transplantation, or any other surgery requiring thoracotomy)
eGFR 60 ml/min/1.73 m2
Patients who agree to receive treatment with SGLT2 inhibitors
Patients must be on current stable hemodynamic profile , without dehydration

Exclusion Criteria

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