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

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ClinicalTrials.gov Identifier: NCT03574857
Recruitment Status : Enrolling by invitation
First Posted : July 2, 2018
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
Emily Burns, 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.

Condition or disease Intervention/treatment Phase
Heart Failure Heart Failure With Reduced Ejection Fraction Heart Failure Acute Cardiovascular Diseases Drug: Metolazone Oral Tablet Drug: Chlorothiazide Injection Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Comparison of Metolazone Versus Chlorothiazide for Acute Decompensated Heart Failure With Diuretic Resistance
Estimated Study Start Date : June 2018
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Active Comparator: Metolazone
Metolazone 5 mg by mouth once daily for 2 days
Drug: Metolazone Oral Tablet
Day 1: Metolazone 5 mg PO Day 2: Metolazone 5 mg PO
Other Name: Zaroxolyn

Active Comparator: Chlorothiazide
Chlorothiazide 500 mg IV once daily for 2 days
Drug: Chlorothiazide Injection
Day 1: Chlorothiazide 500 mg IV Day 2: Chlorothiazide 500 mg IV
Other Name: Diuril




Primary Outcome Measures :
  1. Net urine output at 24 hours [ Time Frame: 24 hours ]
    Milliliters of urine output minus the oral plus intravenous intake


Secondary Outcome Measures :
  1. Net urine output at 48 hours [ Time Frame: 48 hours ]
    Milliliters of urine output minus the oral plus IV intake

  2. Net fluid balance over 12 hours [ Time Frame: 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

  3. Net fluid balance over 24 hours [ Time Frame: 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

  4. Weight change [ Time Frame: 48 hours ]
    Change in documented weight in kg at 48 hours after starting metolazone or chlorothiazide


Other Outcome Measures:
  1. Electrolyte disturbances [ Time Frame: 48 hours ]
    Frequency of hypokalemia, hypomagnesemia, hyponatremia

  2. Worsening renal function [ Time Frame: 48 hours ]
    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

  3. Hospital length of stay [ Time Frame: Assessed until hospital discharge, an average of 7 days ]
    Number of days hospitalized

  4. ICU length of stay [ Time Frame: Assessed until hospital discharge, an average of 7 days ]
    Number of days patient is located in an ICU

  5. In-hospital mortality [ Time Frame: Assessed until hospital discharge, an average of 7 days ]
    Incidence of in-hospital mortality



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03574857


Locations
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United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia

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Responsible Party: Emily Burns, Principle Investigator, University of Virginia
ClinicalTrials.gov Identifier: NCT03574857     History of Changes
Other Study ID Numbers: 20455
First Posted: July 2, 2018    Key Record Dates
Last Update Posted: July 2, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Emily Burns, University of Virginia:
Loop diuretics
Heart failure
Diuretic resistance
Thiazide diuretics

Additional relevant MeSH terms:
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Heart Failure
Cardiovascular Diseases
Heart Diseases
Diuretics
Metolazone
Chlorothiazide
Natriuretic Agents
Physiological Effects of Drugs
Antihypertensive Agents
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action