Metolazone As Early Add On Therapy For Acute Decompensated Heart Failure (MELT-HF): A Multicenter, Randomized Controlled Trial.
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Total urinary output and negative fluid balance
研究概览
简要总结
The primary objective of the study is to determine efficacy of metolazone as synergistic therapy with Lasix in patients with acute decompensated heart failure. This will be a multicenter double blinded randomized placebo- controlled pilot study of the addition of 5 mg of metolazone per day for 2 days compared to placebo in patients admitted with acute decompensated heart failure.
详细描述
AS DESCRIBED BY THE PRINCIPAL INVESTIGATOR (DR. HEYWOOD): The primary objective of the study is to determine efficacy of metolazone as synergistic therapy with Lasix in patients with acute decompensated heart failure. This will be a multicenter double blinded randomized placebo- controlled pilot study of the addition of 5 mg of metolazone per day for 2 days compared to placebo in patients admitted 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
- Triple (Participant, Care Provider, Investigator)
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
- •Subject is 18 years of age at time of enrollment.
- •Admitted with acute decompensated heart failure based on history, physical exam, and laboratory parameters, must include both:
- •At least 1 symptom of either dyspnea, orthopnea, or edema.
- •At least 1 sign of rales on auscultation, peripheral edema, ascites, or pulmonary vascular congestion on chest radiography.
- •Be willing to comply with protocol-specified instructions
- •Able to understand and grant informed consent.
排除标准
- •Inability to give informed consent.
- •Systolic BP < 90 mmHg
- •Creatinine clearance less than 20ml/min or creatinine greater than 2.5mg/dl.
- •Serum Sodium less than 128meq/L, potassium levels less than 3.5meq/L
- •Known adverse reaction to metolazone
- •Inability to take oral medications
- •Severe Aortic Stenosis (AVA < 0.8cm³)
- •History of Hypertrophic Obstructive Cardiomyopathy.
- •Metastatic Carcinoma
- •Severe Chronic Obstructive Pulmonary Disease (COPD), FEV < 1L
- •Severe dyspnea requiring prolonged CPAP or intubation
- •Moderate/Severe Dementia
研究组 & 干预措施
SOC heart failure therapy and placebo pill (Arm A)
This group will receive all standard heart failure therapy and placebo pill.
干预措施: Placebo (Drug)
SOC heart failure therapy with addition of metolazone (Arm B)
This group will receive all standard heart failure therapy with addition of metolazone.
干预措施: Metolazone (Drug)
结局指标
主要结局
Total urinary output and negative fluid balance
时间窗: 48 hours
Total urinary output and negative fluid balance in milliliters (ml) at 48 hours following administration of first dose of intravenous diuretic.
次要结局
- Change in weight(Day 2)
- Degree of improvement in dyspnea(6, 12, 24, 36, and 48 hours)
- All cause mortality(30 days)