Metolazone As Early Add On Therapy For Acute Decompensated Heart Failure

Acute Decompensated Heart Failure Clinical Trial

— MELT-HF  

Official title:

Metolazone As Early Add On Therapy For Acute Decompensated Heart Failure (MELT-HF): A Multicenter, Randomized Controlled Trial.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05633758
• Other study ID #: IRB-14-6311
• Status: Withdrawn
• Phase: Phase 2
• Start date: March 2014
• Est. completion date: March 2016

Study information

• Verified date: November 2022
• Source: Scripps Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Description:

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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:

1. At least 1 symptom of either dyspnea, orthopnea, or edema.

2. 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Acute Decompensated Heart Failure
• Heart Failure

Intervention

Drug:
• Placebo
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 administration of first dose of intravenous diuretic. The second placebo dose is given at 24-hours after the first dose.
• Metolazone
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 administration of first dose of intravenous diuretic The second dose of metolazone is given 24-hours after the first dose.

Locations

Country	Name	City	State
United States	Scripps Green Torrey Pines	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
Scripps Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total urinary output and negative fluid balance	Total urinary output and negative fluid balance in milliliters (ml) at 48 hours following administration of first dose of intravenous diuretic.	48 hours
Secondary	Change in weight	Change in weight from admission to day 2	Day 2
Secondary	Degree of improvement in dyspnea	Dyspnea assessed at 6, 12, 24, 36, and 48 hours with Modified Borg Scale (1-10)	6, 12, 24, 36, and 48 hours
Secondary	All cause mortality	All-cause mortality at 30 days	30 days