Purpose

The purpose of this study is to examine whether administering metolazone 60 minutes prior to furosemide increases urine output compared with administering metolazone and furosemide concomitantly. Participants will have equal chance of being assigned to each group.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 89 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Admission within 48 hours for acute decompensated heart failure with at least one symptom and one sign of volume overload
  • Receipt of loop diuretic prior to admission
  • Plan to administer furosemide 120 - 160 mg IV bolus twice daily over the next 24 hours with additional diuresis deemed necessary
  • If patient is concurrently administered intravenous vasodilator or inotrope, the dose of vasodilator or inotrope must be stable for 6 hours prior to enrollment with a plan to continue the same dose for the 24 hour duration of this study

Exclusion Criteria

  • Metolazone prescribed prior to admission
  • Receipt of continuous intravenous infusion of furosemide
  • Cirrhosis or end stage renal disease
  • Non-English speaking patients

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Prospective, randomized, open-label, active control pilot study
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Metolazone Pre-dosing
Metolazone 5 mg by mouth administered 60 minutes prior to furosemide background therapy (120 - 160 mg intravenous bolus, followed by furosemide 120 - 160 mg intravenous bolus 12 - 24 hours after)
  • Drug: Metolazone 60 minutes prior to furosemide
    All patients will receive furosemide background therapy (furosemide 120 - 160 mg IV bolus dosed twice within a twenty four hour period. Patients will be randomized 1:1 to either metolazone 5 mg tablet dosed 60 minutes prior to first dose of furosemide or metolazone dosed concurrently (within ten minute time frame) with the first dose of furosemide.
    Other names:
    • Zaroxolyn
Active Comparator
Metolazone Concurrent Dosing
Metolazone 5 mg by mouth administered at the same time as furosemide background therapy (120 - 160 mg intravenous bolus, followed by furosemide 120 - 160 mg intravenous bolus 12 - 24 hours after)
  • Drug: Metolazone concurrently with furosemide
    All patients will receive furosemide background therapy (furosemide 120 - 160 mg IV bolus dosed twice within a twenty four hour period. Patients will be randomized 1:1 to either metolazone 5 mg tablet dosed 60 minutes prior to first dose of furosemide or metolazone dosed concurrently (within ten minute time frame) with the first dose of furosemide.
    Other names:
    • Zaroxolyn

Recruiting Locations

University of Maryland Medical Center
Baltimore, Maryland 21201
Contact:
Mallory Mouradjian
401-248-3433
mmouradjian@rx.umaryland.edu

More Details

NCT ID
NCT03746002
Status
Recruiting
Sponsor
University of Maryland

Study Contact

Mallory Mouradjian, PharmD
4012483433
mmouradjian@rx.umaryland.edu

Detailed Description

Diuretic resistance is common among patients with acute decompensated heart failure, and one strategy for overcoming this phenomenon is sequential nephron blockade with loop plus thiazide-type diuretics. Metolazone is an oral thiazide-type diuretic commonly used for this purpose. Due to its delayed absorption, some clinicians suggest that metolazone be given 30-60 minutes prior to the loop diuretic. However, the efficacy and safety of such a strategy has not been investigated despite its added complexity. The purpose of this study is to investigate whether pre-dosing with metolazone confers a difference in efficacy and safety compared to administering it at the same time as furosemide.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.