Effect of Dapagliflozin on left ventricular diastolic function in patients with type 2 diabetic patients with chronic heart failure - Effect of Dapagliflozin on left ventricular diastolic function

Division of Cardiovascular Medicine, Kobe University Graduate School of Medicine0 个研究点目标入组 100 人开始时间: 2015年11月16日最近更新: 2023年10月17日

适应症

试验速览

阶段: 未知
状态: 已完成
发起方
入组人数: 100

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Interventional

入排标准

年龄范围: 20years-old 至 75years-old（—）
性别: All

入选标准

未提供

排除标准

•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

研究者

发起方

Division of Cardiovascular Medicine, Kobe University Graduate School of Medicine

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