Back to resultsMetolazone As Early Add On Therapy For Acute Decompensated Heart Failure (MELT-HF)
Primary Purpose
Acute Decompensated Heart Failure
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Placebo
Metolazone
Sponsored by
About this trial
This is an interventional treatment trial for Acute Decompensated Heart Failure
Eligibility Criteria
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: At least 1 symptom of either dyspnea, orthopnea, or edema. 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
Sites / Locations
- Scripps Green Torrey Pines
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
SOC heart failure therapy and placebo pill (Arm A)
SOC heart failure therapy with addition of metolazone (Arm B)
Arm Description
This group will receive all standard heart failure therapy and placebo pill.
This group will receive all standard heart failure therapy with addition of metolazone.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change in weight
Change in weight from admission to day 2
Degree of improvement in dyspnea
Dyspnea assessed at 6, 12, 24, 36, and 48 hours with Modified Borg Scale (1-10)
All cause mortality
All-cause mortality at 30 days
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05633758
Brief Title
Metolazone As Early Add On Therapy For Acute Decompensated Heart Failure
Acronym
MELT-HF
Official Title
Metolazone As Early Add On Therapy For Acute Decompensated Heart Failure (MELT-HF): A Multicenter, Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Withdrawn
Why Stopped
no participants enrolled
Study Start Date
March 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Scripps Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Decompensated Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SOC heart failure therapy and placebo pill (Arm A)
Arm Type
Placebo Comparator
Arm Description
This group will receive all standard heart failure therapy and placebo pill.
Arm Title
SOC heart failure therapy with addition of metolazone (Arm B)
Arm Type
Active Comparator
Arm Description
This group will receive all standard heart failure therapy with addition of metolazone.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
NA-placebo
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 administration of first dose of intravenous diuretic. The second placebo dose is given at 24-hours after the first dose.
Intervention Type
Drug
Intervention Name(s)
Metolazone
Other Intervention Name(s)
NA-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 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.
Primary Outcome Measure Information:
Title
Total urinary output and negative fluid balance
Description
Total urinary output and negative fluid balance in milliliters (ml) at 48 hours following administration of first dose of intravenous diuretic.
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Change in weight
Description
Change in weight from admission to day 2
Time Frame
Day 2
Title
Degree of improvement in dyspnea
Description
Dyspnea assessed at 6, 12, 24, 36, and 48 hours with Modified Borg Scale (1-10)
Time Frame
6, 12, 24, 36, and 48 hours
Title
All cause mortality
Description
All-cause mortality at 30 days
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
At least 1 symptom of either dyspnea, orthopnea, or edema.
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James T Heywood, MD
Organizational Affiliation
Scripps Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Scripps Green Torrey Pines
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Metolazone As Early Add On Therapy For Acute Decompensated Heart Failure
We'll reach out to this number within 24 hrs