Clinical Study Comparing Empagliflozin, Acetazolamide, and Metolazone as Add-on Therapies to Loop Diuretics in Acute Decompensated Heart Failure
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- The cumulative urine output measured over 3 days
研究概览
简要总结
The aim of this study is to compare the efficacy and safety of empagliflozin, acetazolamide, and metolazone as add-on therapies to loop diuretics in patients with acute decompensated heart failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Masking Description
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients older than 18 years.
- •Hospital admission with clinical diagnosis of acute decompensated heart failure with at least one clinical sign of volume overload (e.g. edema, ascites confirmed by echography or pleural effusion confirmed by chest X-ray or echography).
排除标准
- •Type 1 diabetes.
- •Chronic kidney disease with estimated glomerular filtration rate (eGFR) <30 mL/min per 1.73 m² or end-stage kidney failure with the need for chronic dialysis treatment.
- •A systolic blood pressure of less than 90 mmHg.
- •Cardiogenic shock.
- •Receipt of acetazolamide maintenance therapy.
- •Receipt of an SGLT2 inhibitor, thiazide, or thiazide-like diuretic in the 48 hrs before randomization.
- •Any cause of heart failure leading to decompensation that will need urgent management (eg, acute coronary syndrome, unstable arrhythmias, acute pulmonary embolism).
- •Pregnant or breastfeeding women.
- •Moderate to severe anemia.
研究组 & 干预措施
Empagliflozin group
will include 22 patients who will receive 10 mg oral empagliflozin administered simultaneously with the first dose of loop diuretics each day for 3 days
干预措施: empagliflozin (Drug)
Acetazolamide group
will include 22 patients who will receive 500 mg oral acetazolamide administered simultaneously with the first dose of loop diuretics each day for 3 days
干预措施: Acetazolamide (Drug)
Metolazone group
will include 22 patients who will receive 5 mg oral metolazone administered simultaneously with the first dose of loop diuretics each day for 3 days
干预措施: metolazone (Drug)
结局指标
主要结局
The cumulative urine output measured over 3 days
时间窗: 3 days
次要结局
- - The change in serum level of N-terminal pro-brain natriuretic peptide (NT-proBNP)(4 days)
- The change in serum level of Soluble suppression of tumorigenicity 2 (sST2)(4 days)
- The change in urinary level of Tissue inhibitor of metalloproteinases-2 (TIMP-2 )(3 days)
- The change in urinary level of Insulin-like growth factor-binding protein 7 (IGFBP7)(3 days)
- 30-day mortality(up to 30 days)
- Proportion of patients achieving an ADVOR Score ≤ 1 without the need for escalating diuretic strategy(3 days)
研究者
Dalia Abdelhamid Gomaa
assistant lecturer of clinical pharmacy, faculty of pharmacy
Tanta University