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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03574857
Other study ID # 20455
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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