Prospective Comparison of Metolazone Versus Chlorothiazide for Acute Decompensated Heart Failure With Diuretic Resistance

NCT ID: NCT03574857

Last Updated: 2021-02-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-01
• Study Completion Date: 2021-01-01

Brief Summary

The primary objective of the study is to compare efficacy of metolazone and chlorothiazide as add-on therapy in patients refractory to loop diuretics with heart failure with a reduced ejection fraction (HFrEF). This will be a single-center randomized pilot study.

Conditions

Heart Failure; Heart Failure With Reduced Ejection Fraction; Heart Failure Acute; Cardiovascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Metolazone

Metolazone 5 mg by mouth once daily for 2 days

Group Type: ACTIVE_COMPARATOR

Metolazone Oral Tablet

Intervention Type: DRUG

Day 1: Metolazone 5 mg PO Day 2: Metolazone 5 mg PO

Chlorothiazide

Chlorothiazide 500 mg IV once daily for 2 days

Group Type: ACTIVE_COMPARATOR

Chlorothiazide Injection

Intervention Type: DRUG

Day 1: Chlorothiazide 500 mg IV Day 2: Chlorothiazide 500 mg IV

Interventions

Metolazone Oral Tablet

Day 1: Metolazone 5 mg PO Day 2: Metolazone 5 mg PO

Intervention Type: DRUG

Chlorothiazide Injection

Day 1: Chlorothiazide 500 mg IV Day 2: Chlorothiazide 500 mg IV

Intervention Type: DRUG

Other Intervention Names

Zaroxolyn; Diuril

Eligibility Criteria

Inclusion Criteria

• Age > 18 years old
• Admitted for acute decompensated HF with left ventricular ejection fraction (LVEF) <40%
• Refractory fluid overload:
• Unresponsive (<500 mL net negative over previous 24 hours) AND ineffective diuresis (determined by HF team) to moderate intensity push or low intensity continuous infusion loop diuretic (80 mg IV furosemide or equivalent bumetanide dose of 4 mg)
• English or Spanish-speaking subjects
• Willing and able to comply with study procedures

Exclusion Criteria

• Baseline thiazide use prior to admission or prior to study enrollment
• Renal replacement therapies (RRT) or glomerular filtration rate (GFR) <30 mL/min at the time of enrollment
• Pregnant women
• Cognitive impairment
• Prisoners
• Left ventricular assist devices (LVAD) or temporary mechanical circulatory support devices
• History of cardiac transplant
• Reported allergy to thiazides
• No enteral access or unable to take medications enterally
• Palliative diuretics
• Systolic blood pressure (SBP) <90 mm Hg prior to randomization
• Patients receiving concomitant lithium therapy

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

Sponsors

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Emily Burns

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Virginia Health System

Charlottesville, Virginia, United States

Countries

United States

Other Identifiers

20455

Identifier Type: -

Identifier Source: org_study_id