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

Phase 4

Terminated

• Conditions: Heart Failure Acute; Heart Failure; Heart Failure With Reduced Ejection Fraction; Cardiovascular Diseases
• Interventions: Drug: Metolazone Oral Tablet; Drug: Chlorothiazide Injection

• Registration Number: NCT03574857
• Lead Sponsor: University of Virginia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-16
• Study Start: 2018-06-01
• Study First Submitted QC: 2018-06-20
• Study First Posted: 2018-07-02
• Primary Completion: 2021-01-01
• Study Completion: 2021-01-01
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-10
• Last Update Posted: 2021-02-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metolazone	Metolazone Oral Tablet	Metolazone 5 mg by mouth once daily for 2 days
Chlorothiazide	Chlorothiazide Injection	Chlorothiazide 500 mg IV once daily for 2 days

Primary Outcome Measures

Name	Time	Method
Net urine output at 24 hours	24 hours	Milliliters of urine output minus the oral plus intravenous intake

Secondary Outcome Measures

Name	Time	Method
Net fluid balance over 12 hours	24 hours	the net fluid balance over 12 and 24 hours prior to the addition of metolazone or chlorothiazide compared to the 12 hours after addition of the study drug
Net fluid balance over 24 hours	48 hours	Net fluid balance over 24 hours prior to the addition of metolazone or chlorothiazide compared to the 24 hours after addition of the study drug
Net urine output at 48 hours	48 hours	Milliliters of urine output minus the oral plus IV intake
Weight change	48 hours	Change in documented weight in kg at 48 hours after starting metolazone or chlorothiazide

Trial Locations

Locations (1)

University of Virginia Health System; 🇺🇸 Charlottesville, Virginia, United States