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Diuretic

Metolazone Pre-dosing for Heart Failure

Phase 4
Waitlist Available
Led By Brent Reed, PharmD
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and at 12 to 23 hours after metolazone dose
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
No Placebo-Only Group
Pivotal Trial
Drug Has Already Been Approved

Summary

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.

Eligible Conditions
  • Heart Failure
  • Fluid Overload

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and at 12 to 23 hours after metolazone dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and at 12 to 23 hours after metolazone dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
24-Hour Urine Output
Secondary study objectives
Acute Kidney Injury
Change in Serum Creatinine
Change in Total Body Weight
+3 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Active Control
Group I: Metolazone Pre-dosingActive Control1 Intervention
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)
Group II: Metolazone Concurrent DosingActive Control1 Intervention
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)

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor
710 Previous Clinical Trials
379,156 Total Patients Enrolled
15 Trials studying Heart Failure
1,894 Patients Enrolled for Heart Failure
Brent Reed, PharmDPrincipal InvestigatorUniversity of Maryland, College Park
~0 spots leftby Oct 2025
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