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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Acute Decompensated Heart Failure

In brief

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.

Key facts

Study ID

NCT02620384

Run by

Aultman Health Foundation

People needed

147

Starts

2015-10-01

Expected to finish

2017-12-29

Last updated by the study team

2019-02-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Aultman Health Foundation — Canton, Ohio, United States

Full record on ClinicalTrials.gov

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