Effect of Dapagliflozin on left ventricular diastolic function in patients with type 2 diabetic patients with chronic heart failure
- Conditions
- Type 2 diabetic patients with chronic heart failure
- Registration Number
- JPRN-UMIN000019789
- Lead Sponsor
- Division of Cardiovascular Medicine, Kobe University Graduate School of Medicine
- Brief Summary
Primary end point E/e showed significant decrease from 9.3 cm/s (7.7-11.8) to 8.5 cm/s (6.6-10.7) (p=0.020) 6 months after administration of dapagliflozin. Secondary end point LAVI and LVMI showed significant decreases from 31 mL/m2 (23-45) to 26 mL/m2 (21-32) (p=0.001), and from 75.0 g/m2 (61.7-92.0) to 67.0 g/m2 (55.0-81.9) (p<0.001) 6 months after administration of dapagliflozin, respectively. No significant change was observed in BNP 6 months after administration of dapagliflozin from 27.9 pg/mL (9.0-58.2) at baseline to 28.9 pg/mL (9.6-62.9) (p=0.132), but BNP significantly decreased from 168.8 pg/mL (144.3-465.3) to 114.3 pg/mL (98.3-235.3) (p = 0.012) in T2DM patients with BNP>100 pg/mL.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 100
Not provided
1) Tpe 1 diabetis 2) Blood pressure of <90/50 mmHg 3) Has history of heart failure, acute coronary syndrome, cerebrovascular disease, myocarditis, constrictive pericarditis, or severe valvular disease within 4 months 4) Has history of uncontrolled atrial fibrillation or flutter within 1 month. 5) Has history of diabetic ketoacidosis, diabetic coma, or hypoglycemic attack within 6 months 6) Current use of insuline 7) With severe renal dysfunction (eGRF < 45 mL/min/1.73m 2 or patient undergoing artificial dialysis) 8) Has malignancy 9) With serious liver disfunction (AST or ALT is 3 times site reference value or more) 10) With pituitary gland dysfunction or adrenal gland dysfunction 11) With malnutrition, starvation, irregular eating pattern, lack of dietary intake, debilitaion 12) Pregnant, possibly pregnant, planned to become pregmant or nursing women 13) Has history of hypersensitivity to dapagliflozin, glimepiride or sulfonamides 14) Are considered not eligible for the study by the attending doctor due to other reasons
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method eft ventricular diastolic function by means of echocardiography after 6- and 12-month after administration of dapagliflozin (E/A, E/E', left atrial volume index and left ventricular mass index)
- Secondary Outcome Measures
Name Time Method BNP after 6- and 12-month after administration of dapagliflozin