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

Sponsor
Hongchang Guo
Study ID
NCT04340908
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin 10 MG — DRUG
    10 mg tablet, oral, once daily, 1-year treatment, postoperation
  • Placebos — DRUG
    matching placebo tablet, oral, once daily, 1-year treatment, postoperation

Study Details

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.

Key Dates

Start date
Jan 1, 2021
Status verified
Oct 2021
Primary completion
Jun 1, 2022
Completion
Jun 1, 2023

Study Design

Enrollment
500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment
    Dapagliflozin 10 mg tablet
  • Placebo Comparator: Control
    matching placebo tablet

Primary Outcome Measure

Difference in mean EF% between the treatment and control study arms [ Time Frame: 2 year ]

Central Contacts

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