Heart Failure Clinical Trial

Metolazone As Early Add On Therapy For Acute Decompensated Heart Failure

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.

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Full 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.

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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

Study is for people with:

Heart Failure

Phase:

Phase 2

Study ID:

NCT05633758

Recruitment Status:

Withdrawn

Sponsor:

Scripps Health

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There is 1 Location for this study

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Scripps Green Torrey Pines
La Jolla California, 92037, United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Phase 2

Study ID:

NCT05633758

Recruitment Status:

Withdrawn

Sponsor:


Scripps Health

How clear is this clinincal trial information?

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