Clinical Research Directory
Browse clinical research sites, groups, and studies.
Optimal Diuretic Therapies for Acute Heart Failure With Volume Overload
Sponsor: Johannes Grand
Summary
This trial aims to identify the best strategy for treating acute heart failure (AHF) with volume overload in patients at risk of diuretic resistance. It is a double-blinded, randomized, controlled, multicenter study comparing loop-diuretics combined with metolazone, loop-diuretics combined with acetazolamide, and loop-diuretics with matching placebos. Eligible participants are adults aged 18 years or older who are hospitalized with AHF and have clinical signs of congestion and a risk of diuretic resistance. The primary outcome is the number of days alive and out of hospital through day 30. Secondary outcomes are clinical benefit at 30 days, assessed using a hierarchical win ratio; days alive and out of hospital through day 90; and the duration of the index hospital admission. The trial aims to enroll 939 participants across three treatment arms (313 per arm). The sample size is based on detecting a clinically relevant between-group difference of two days alive and out of hospital through day 30, with 80% power and adjustment for comparisons between the three groups.
Official title: Optimal Diuretic Therapies for Acute Heart Failure With Volume Overload - A Randomized Clinical Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
939
Start Date
2024-09-05
Completion Date
2028-05-01
Last Updated
2026-10-27
Healthy Volunteers
No
Conditions
Interventions
Acetazolamide
Acetazolamide 500 mg IV at randomization (day 0) and on the next three mornings (days 1, 2 and 3), with a matching placebo-metolazone tablet at each administration. The intervention phase does not exceed 72 hours and is stopped earlier at complete decongestion, discharge, or protocol-defined stopping criteria. Loop-diuretic treatment follows clinical assessment and current guidelines.
Metolazone 2.5 MG
Metolazone 2.5 mg orally at randomization (day 0) and on the next three mornings (days 1, 2 and 3), with a matching placebo-acetazolamide injection at each administration. The intervention phase does not exceed 72 hours and is stopped earlier at complete decongestion, discharge, or protocol-defined stopping criteria. Loop-diuretic treatment follows clinical assessment and current guidelines.
Double-placebo
Matching placebo-acetazolamide injection and placebo-metolazone tablet at randomization (day 0) and on the next three mornings (days 1, 2 and 3), in addition to usual care with loop-diuretics (SGLT2 inhibitors are allowed). The intervention phase does not exceed 72 hours and is stopped earlier at complete decongestion, discharge, or protocol-defined stopping criteria. Loop-diuretic treatment follows clinical assessment and current guidelines.
Locations (6)
Amager-Hvidovre Hospital
Hvidovre, Capital Region of Denmark, Denmark
Aarhus University Hospital
Aarhus N, Denmark
Bispebjerg Hospital
Copenhagen, Denmark
Herlev Hospital
Herlev, Denmark
Odense University Hospital
Odense C, Denmark
Zealand University Hospital
Roskilde, Denmark