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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Dapagliflozin 10 mg tablet |
|
| Control | Placebo Comparator | matching placebo tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin 10 MG | Drug | 10 mg tablet, oral, once daily, 1-year treatment, postoperation |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei, M.D. | Contact | +86 19800367660 | weizhipeng@outlook.com |
| Name | Affiliation | Role |
|---|---|---|
| Lai, M.D. | Beijing Anzhen Hospital | Study Chair |
| Guo, M.D. | Beijing Anzhen Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital, Capital Mediacal University | Recruiting | Beijing | Beijing Municipality | 100000 | China |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
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| Placebos | Drug | matching placebo tablet, oral, once daily, 1-year treatment, postoperation |
|
| 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 |