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

NCT02620384 | Terminated Phase 3 Results DMC FDA Drug

• 1 other identifier: 2015.03.26.F2
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Decompensated Heart Failure

Keywords

Metolazone; Heart Failure

Outcome Measures

Primary Outcomes (2)

• Total Urinary Output at 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.

  48 hours

• Fluid Balance at 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.

  48 hours

Secondary Outcomes (5)

• 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

Other Outcomes (5)

• Length of Hospital Stay

  Inpatient Hospitalization

• All Cause Readmission Within 30 Days

  30 Days

• Heart Failure Readmission Within 30 Days

  30 Days

Study Arms (2)

Experimental: Placebo

PLACEBO COMPARATOR

This group will receive all standard heart failure therapy and placebo pill.

Drug: Experimental: Placebo

Experimental: Metolazone

ACTIVE COMPARATOR

This group will receive all standard heart failure therapy with addition of metolazone.

Drug: Experimental: Metolazone

Interventions

Experimental: Placebo DRUG

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.

Experimental: Placebo

Experimental: Metolazone DRUG

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.

Experimental: Metolazone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• 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

Sponsors & Collaborators

• Aultman Health Foundation: lead

Study Sites (1)

Aultman Health Foundation

Canton, Ohio, 44710, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Limitations and Caveats

Recruitment ended early due to limited resources,however all protocol directed measures were completed for all enrolled. I\&O was measured and recorded manually which introduces room for error.BORG assessment timing not exact due to limited resources.

Results Point of Contact

• Title: Director of Research Programs
• Organization: Aultman Hospital

mary.amos@aultman.com

330-363-7274

Study Officials

• Muhammad Chaudhry, MD

  Aultman Health Foundation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2015
• First Posted: December 3, 2015
• Study Start: October 1, 2015
• Primary Completion: November 29, 2017
• Study Completion: December 29, 2017
• Last Updated: February 15, 2019
• Results First Posted: February 15, 2019

Record last verified: 2019-01

Locations

US (1)