Metolazone As Early Add On Therapy For Acute Decompensated Heart Failure (MELT-HF)--A Single Center Pilot Study.
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 147
- 试验地点
- 2
- 主要终点
- Total Urinary Output at 48 Hours
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 single center 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
Heart failure is a major source of morbidity, mortality and growing public health cost. In US, the number of congestive heart failure patients is more than 4 million with more than 550,000 new annually reported cases. The annual cost of heart failure management exceeds 35 billion dollars per year.The heart failure readmissions and average length of hospital stay cost approximately $11,000 per patient.
Loop diuretics are used alone in the majority of cases to promote diuresis. An association of increased creatinine and increased risk of renal dysfunction, the cardiorenal syndrome, in the face of high dose loop diuretics has raised questions regarding the safety and toxicity of high dose loop diuretics. While the dose of diuretics is ubiquitous, little data exists to guide their use and many clinicians are uncertain as to when and how to initiate and limit therapy.
Prospective randomized data on large number of decompensated heart failure patients receiving metolazone in addition to standard therapy is scarce and needs further definitive evaluation in terms of clinical outcomes and safety. In many cases, a "stepped approach" with oral loop diuretics advancing to intravenous and finally combination high dose diuretics is employed.
Primary endpoint: Total urinary output and negative fluid balance in millilitres (ml) at 48 hours following first dose of intravenous diuretic.
Secondary endpoints:
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
- •Age 18 years or older
- •Current hospitalization for chronic congestive heart failure with admission up to 48 hours prior to inclusion.
- •Chronic heart failure will be defined as requiring treatment for a minimum of 30 days prior to current admission, NYHA Class III or IV at the time of hospitalization, and left ventricular ejection fraction less than 40% within one year or evidence of heart failure with preserved ejection fraction and evidence of diastolic dysfunction on echocardiogram.
- •Admitted with clinical decompensated heart failure based on history, physical exam, and parameters indicating extracellular volume expansion such as including JVP ≥ 8 cm of water and 1+ or greater peripheral edema
- •Is able to be dosed with study medication within six (6) hours of first dose of IV diuretics
排除标准
- •Baseline severe hypotension (Mean arterial pressure < 55 mm Hg)
- •Creatinine clearance less than 20 ml/min or creatinine greater than 2.5 mg/dl.
- •Serum sodium less than 128 meq/L.
- •Serum Potassium < 3.0 meq/L.
- •Known adverse reaction to metolazone
- •Inability to take oral medications
- •Severe Aortic Stenosis (AVA < 0.8cm2)
- •History of Hypertrophic obstructive cardiomyopathy
- •Metastatic Carcinoma per history
- •Severe COPD, FEV < 1L
- •Severe dyspnea requiring prolonged CPAP,BIPAP or intubation
研究组 & 干预措施
Experimental: Placebo
This group will receive all standard heart failure therapy and placebo pill.
干预措施: Experimental: Placebo (Drug)
Experimental: Metolazone
This group will receive all standard heart failure therapy with addition of metolazone.
干预措施: Experimental: Metolazone (Drug)
结局指标
主要结局
Total Urinary Output at 48 Hours
时间窗: 48 hours
Total urinary output in milliliters (ml) at 48 hours. Measurement timing began with administration of first dose of investigational product, ended 48 hours later.
Fluid Balance at 48 Hours
时间窗: 48 hours
Difference in value between input and output in milliliters (ml) at 48 hours. Measurement timing began with administration of first dose of investigational product, ended 48 hours later. Fluid balance = Fluid in minus Fluid out.
次要结局
- Change in Weight First 48 Hours(48 hours)
- Degree of Improvement in Dyspnea at 6, 12, 24, 36 and 48 Hours.(6, 12, 24, 36 and 48 hours.)
- Total Dose Diuretics First 48 Hours(48 hours)
- Number of Participants With Inotrope Administration During First 48 Hours(48 hours)
- All Cause Mortality at 30 Days(30 Days)