Heart Failure Clinical Trial
Official title:
Prospective Comparison of Metolazone Versus Chlorothiazide for Acute Decompensated Heart Failure With Diuretic Resistance
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 |
Verified date | February 2021 |
Source | University of Virginia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Virginia Health System | Charlottesville | Virginia |
Lead Sponsor | Collaborator |
---|---|
University of Virginia |
United States,
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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