Metolazone As Early Add On Therapy For Acute Decompensated Heart Failure (MELT-HF)--A Single Center Pilot Study.
Condition: Acute Decompensated Heart Failure
MeSH terms: Heart Failure
Intervention: Experimental: Placebo; Experimental: Metolazone
Intervention description: All patients will receive standard heart failure therapy, including but not restricted to diuretics, digoxin, angiotensin converting enzyme inhibitors or angiotensin II receptor blockers, beta blockers, aldosterone antagonists, hydralazine, and/or nitrates, at the discretion of the treating physician. After informed consent is obtained, patients will be randomized 1:1 to the treatment arm or placebo arm. The first placebo dose is given within six hours of admininstration of first dose of intravenous diuretic. The second placebo dose is given at 24-hours after the first dose.; All patients will receive standard heart failure therapy, including but not restricted to diuretics, digoxin, angiotensin converting enzyme inhibitors or angiotensin II receptor blockers, beta blockers, aldosterone antagonists, hydralazine, and/or nitrates, at the discretion of the treating physician. After informed consent is obtained, patients will be randomized 1:1 to the treatment arm or placebo arm. The first dose of metolazone is given within six hours of admininstration of first dose of intravenous diuretic The second dose of metolazone is given 24-hours after the first dose.
Intervention MeSH terms: Metolazone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 147.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Metolazone; Heart Failure

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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