Metolazone As Early Add On Therapy For Acute Decompensated Heart Failure

NCT ID: NCT05633758

Last Updated: 2022-12-01

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2016-03-31

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.

Conditions

Acute Decompensated Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

SOC heart failure therapy and placebo pill (Arm A)

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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 administration of first dose of intravenous diuretic. The second placebo dose is given at 24-hours after the first dose.

SOC heart failure therapy with addition of metolazone (Arm B)

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

Group Type: ACTIVE_COMPARATOR

Metolazone

Intervention Type: 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 administration of first dose of intravenous diuretic The second dose of metolazone is given 24-hours after the first dose.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

NA-placebo; NA-Metolazone

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:

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Scripps Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James T Heywood, MD

Role: PRINCIPAL_INVESTIGATOR

Scripps Health

Locations

Scripps Green Torrey Pines

La Jolla, California, United States

Countries

United States

Other Identifiers

IRB-14-6311

Identifier Type: -

Identifier Source: org_study_id