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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03574857
• Other study ID #: 20455
• Status: Terminated
• Phase: Phase 4
• Start date: June 1, 2018
• Est. completion date: January 1, 2021

Study information

• Verified date: February 2021
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: January 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Metolazone Oral Tablet
Day 1: Metolazone 5 mg PO Day 2: Metolazone 5 mg PO
• Chlorothiazide Injection
Day 1: Chlorothiazide 500 mg IV Day 2: Chlorothiazide 500 mg IV

Locations

Country	Name	City	State
United States	University of Virginia Health System	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Electrolyte disturbances	Frequency of hypokalemia, hypomagnesemia, hyponatremia	48 hours
Other	Worsening renal function	increase in serum creatinine greater that 0.5 mg/dL from the patient's baseline value on the day of the first dose of chlorothiazide or metolazone	48 hours
Other	Hospital length of stay	Number of days hospitalized	Assessed until hospital discharge, an average of 7 days
Other	ICU length of stay	Number of days patient is located in an ICU	Assessed until hospital discharge, an average of 7 days
Other	In-hospital mortality	Incidence of in-hospital mortality	Assessed until hospital discharge, an average of 7 days
Primary	Net urine output at 24 hours	Milliliters of urine output minus the oral plus intravenous intake	24 hours
Secondary	Net urine output at 48 hours	Milliliters of urine output minus the oral plus IV intake	48 hours
Secondary	Net fluid balance over 12 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	24 hours
Secondary	Net fluid balance over 24 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	48 hours
Secondary	Weight change	Change in documented weight in kg at 48 hours after starting metolazone or chlorothiazide	48 hours