Metolazone As Early Add On Therapy For Acute Decompensated Heart Failure (MELT-HF)--A Single Center Pilot Study.

• Status: Terminated
• Trial end date: 2017-12-29
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aultman Health Foundation; Muhammad Chaudhry, MD
• Treatments: Angiotensin Receptor Antagonists; Angiotensin-Converting Enzyme Inhibitors; Enzyme Inhibitors; Metolazone; Mineralocorticoid Receptor Antagonists

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