Effects of SGLT2 Inhibitor on Type 2 Diabetic Patients Undergoing Cardiac Surgery
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|ClinicalTrials.gov Identifier: NCT04340908|
Recruitment Status : Recruiting
First Posted : April 10, 2020
Last Update Posted : July 9, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2 Cardiac Surgery||Drug: Dapagliflozin 10 MG Drug: Placebos||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effects of SGLT2 Inhibitor on Type 2 Diabetic Patients Undergoing Cardiac Surgery|
|Estimated Study Start Date :||July 1, 2020|
|Estimated Primary Completion Date :||June 1, 2022|
|Estimated Study Completion Date :||June 1, 2023|
Dapagliflozin 10 mg tablet
Drug: Dapagliflozin 10 MG
10 mg tablet, oral, once daily, 1-year treatment, postoperation
Other Name: Forxiga
Placebo Comparator: Control
matching placebo tablet
matching placebo tablet, oral, once daily, 1-year treatment, postoperation
- Difference in mean EF% between the treatment and control study arms [ Time Frame: 2 year ]Echocardiography is used to assess cardiac function.
- Difference in NTproBNP between the treatment and control study arms [ Time Frame: 2 year ]NT-proBNP is used to assess cardiac function.
- All-cause postoperative mortality [ Time Frame: 2 year ]All-cause mortality identified during two years follow-up.
- Rehospitalization for cardiovascular causes [ Time Frame: 2 year ]Rehospitalization due to cardiovascular diseases during two years follow-up.
- Serious postoperative infection [ Time Frame: 2 year ]Including postoperative sternal dehiscence, external genital infections, etc.
- Acute postoperative kidney injury [ Time Frame: 2 year ]Acute postoperative kidney injury requiring renal replacement therapy
- Hypoglycemia [ Time Frame: 2 year ]Identified using ICD9 and ICD10 codes and reported as rates.
- Duration of Hospitalization [ Time Frame: 2 year ]Days from date of surgery to hospital discharge.
- Diabetic ketoacidosis [ Time Frame: 2 year ]Identified using ICD9 and ICD10 codes and reported as rates.
- Lactic acidosis [ Time Frame: 2 year ]Identified using ICD9 and ICD10 codes and reported as rates.
- Post operative atrial fibrillation [ Time Frame: 7 days ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04340908
|Contact: Wei, M.D.||+86 email@example.com|
|Beijing Anzhen Hospital, Capital Mediacal University||Recruiting|
|Beijing, Beijing, China, 100000|
|Contact: Wei, M.D. firstname.lastname@example.org|
|Study Chair:||Lai, M.D.||Beijing Anzhen Hospital|
|Study Director:||Guo, M.D.||Beijing Anzhen Hospital|