Viewing Study NCT03746002


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Study NCT ID: NCT03746002
Status: TERMINATED
Last Update Posted: 2021-10-22
First Post: 2018-11-15
Is NOT Gene Therapy: True
Has Adverse Events: True

Brief Title: Diuretic Effect of Metolazone Pre-dosing Versus Concurrent Dosing
Sponsor: University of Maryland, Baltimore
Organization:

Study Overview

Official Title: Diuretic Effect of Metolazone Pre-dosing Versus Concurrent Dosing With Furosemide: a Pilot Study
Status: TERMINATED
Status Verified Date: 2021-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Insufficient rate of patient enrollment/accrual.
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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.
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.

Study Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: True
Is an FDA AA801 Violation?: