Safety and Efficacy of Adding Dapagliflozin and Furosemide in Diabetic Patients (Type 2) With Decompensated Heart Failure With Reduced Ejection Fraction (HFrEF)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Changes in body weight measurement (Diuresis effect.)
研究概览
简要总结
We hypothesize that Dapagliflozin could improve the diuretic response in diabetic patients with acute decompensated heart failure owing to its diuretic effect in addition to improvement of blood glucose level without remarkable effect on kidney function or electrolytes.
详细描述
The study will include 100 diabetic patients type 2 patients who will be admitted to care unit with decompensated heart failure.50 patient will receive Dapagliflozin plus insulin (if needed) and Diuretics plus conventional heart failure measures ,the other group will receive insulin for control of blood sugar plus diuretics and anti-failure measures.
Inclusion Criteria:
Diabetic patient type 2 with history of chronic heart failure(HFrEF) ,there is no specified inclusion criterion with respect to heart failure etiology and/or ejection fraction.
Age more than 18 years Admission for acute decompensated heart failure The patient already on an oral loop diuretic for at least 1 month before admission, at a dose between 40 mg and 80 mg daily in the case of furosemide and an equivalent dose in the case of a different loop diuretic (20 mg of Torsemide will be considered to be equivalent to 40 mg of furosemide.
Exclusion Criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetic patient type 2 with history of chronic heart failure(HFrEF) ,there is no prespecified inclusion criterion with respect to heart failure etiology and/or ejection fraction.
排除标准
- •Other etiologies of fluid overload different from heart failure.
- •Hyponatremia: Sodium level below 125mmol/l
- •Unstable patients: acute coronary syndrome, cardiogenic shock .
- •Patients requiring inotropic agents or renal dialysis.
- •Pregnancy or breastfeeding period.
- •sever hepatic disease
- •GFR is less than 45 mL/min/1.73 m² .
- •Patient with diabetic ketoacidosis or non ketotic hyperosmolar.
研究组 & 干预措施
Dapagliflozin group
50 patients will receive Dapagliflozin plus insulin (if needed) and Diuretics plus conventional heart failure measures.
干预措施: Dapagliflozin (Drug)
Dapagliflozin group
50 patients will receive Dapagliflozin plus insulin (if needed) and Diuretics plus conventional heart failure measures.
干预措施: insulin (Drug)
Placebo group
50 patients will receive insulin for control of blood sugar plus diuretics and anti-failure measures.
干预措施: insulin (Drug)
结局指标
主要结局
Changes in body weight measurement (Diuresis effect.)
时间窗: Days of admission (3-5 days)
Diuretic response will be measured by weight loss
Diuresis effect.
时间窗: Days of admission (3-5 days)
Diuretic response will be measured by net fluid loss per mg .
次要结局
- Renal function(Days of admission (3-5 days))
- Patient-reported dyspnea will be assessed with the use five point Linker scale(Days of admission (3-5 days))
研究者
Mohamed Abdelfatah
principal investigator
Assiut University