Metolazone As Early Add On Therapy For Acute Decompensated Heart Failure

Phase 2

Withdrawn

• Conditions: Acute Decompensated Heart Failure
• Interventions: Drug: Placebo; Drug: Metolazone

• Registration Number: NCT05633758
• Lead Sponsor: Scripps Health

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.

Study Timeline

• Study Start: 2014-03
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2022-11
• Study First Submitted: 2022-11-21
• Study First Submitted QC: 2022-11-21
• Last Update Submitted: 2022-11-21
• Study First Posted: 2022-12-01
• Last Update Posted: 2022-12-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SOC heart failure therapy and placebo pill (Arm A)	Placebo	This group will receive all standard heart failure therapy and placebo pill.
SOC heart failure therapy with addition of metolazone (Arm B)	Metolazone	This group will receive all standard heart failure therapy with addition of metolazone.

Primary Outcome Measures

Name	Time	Method
Total urinary output and negative fluid balance	48 hours	Total urinary output and negative fluid balance in milliliters (ml) at 48 hours following administration of first dose of intravenous diuretic.

Secondary Outcome Measures

Name	Time	Method
Change in weight	Day 2	Change in weight from admission to day 2
Degree of improvement in dyspnea	6, 12, 24, 36, and 48 hours	Dyspnea assessed at 6, 12, 24, 36, and 48 hours with Modified Borg Scale (1-10)
All cause mortality	30 days	All-cause mortality at 30 days

Trial Locations

Locations (1)

Scripps Green Torrey Pines; 🇺🇸 La Jolla, California, United States