NCT03574857终止4 期
Prospective Comparison of Metolazone Versus Chlorothiazide for Acute Decompensated Heart Failure With Diuretic Resistance
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Net urine output at 24 hours
研究概览
简要总结
The primary objective of the study is to compare efficacy of metolazone and chlorothiazide as add-on therapy in patients refractory to loop diuretics with heart failure with a reduced ejection fraction (HFrEF). This will be a single-center randomized pilot study.
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
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
- •Age > 18 years old
- •Admitted for acute decompensated HF with left ventricular ejection fraction (LVEF) <40%
- •Refractory fluid overload:
- •Unresponsive (<500 mL net negative over previous 24 hours) AND ineffective diuresis (determined by HF team) to moderate intensity push or low intensity continuous infusion loop diuretic (80 mg IV furosemide or equivalent bumetanide dose of 4 mg)
- •English or Spanish-speaking subjects
- •Willing and able to comply with study procedures
排除标准
- •Baseline thiazide use prior to admission or prior to study enrollment
- •Renal replacement therapies (RRT) or glomerular filtration rate (GFR) <30 mL/min at the time of enrollment
- •Pregnant women
- •Cognitive impairment
- •Prisoners
- •Left ventricular assist devices (LVAD) or temporary mechanical circulatory support devices
- •History of cardiac transplant
- •Reported allergy to thiazides
- •No enteral access or unable to take medications enterally
- •Palliative diuretics
- •Systolic blood pressure (SBP) <90 mm Hg prior to randomization
- •Patients receiving concomitant lithium therapy
研究组 & 干预措施
Metolazone
Active Comparator
Metolazone 5 mg by mouth once daily for 2 days
干预措施: Metolazone Oral Tablet (Drug)
Chlorothiazide
Active Comparator
Chlorothiazide 500 mg IV once daily for 2 days
干预措施: Chlorothiazide Injection (Drug)
结局指标
主要结局
Net urine output at 24 hours
时间窗: 24 hours
Milliliters of urine output minus the oral plus intravenous intake
次要结局
- Net fluid balance over 12 hours(24 hours)
- Net fluid balance over 24 hours(48 hours)
- Net urine output at 48 hours(48 hours)
- Weight change(48 hours)
研究者
Emily Burns
Principle Investigator
University of Virginia
研究点 (1)
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