Comparing Diuretic Combinations for Acute Heart Failure With Fluid Buildup
Tests two added water pills with standard diuretics in adults hospitalized with acute heart failure.
Plain-language title generated from the registry record
Registry title: Optimal Diuretic Therapies for Acute Heart Failure With Volume Overload
Key facts
- Where
- Aarhus N, Herlev, Hvidovre, København, Odense C, and Roskilde, DenmarkSee the 6 sites
- Phase
- Phase 3
Where in Denmark
- Aarhus UniversitetshospitalAarhus N, DenmarkTaking people
- Herlev HospitalHerlev, DenmarkTaking people
- Hvidovre HospitalHvidovre, DenmarkTaking people
- Bispebjerg HospitalKøbenhavn, DenmarkTaking people
- Odense University HospitalOdense C, DenmarkTaking people
- Copenhagen University HospitalRoskilde, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Johannes Grand
- Trial code
- NCT06166654EU 2024-510633-17-00
- Record updated
- 27 October 2026
- Original description
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.Read full original descriptionShow less
Optimal Diuretic Therapies for Acute Heart Failure With Volume Overload - A Randomized Clinical Trial
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.
Inclusion: Age ≥ 18 years; Acute hospital admission with a clinical diagnosis of acute heart failure with volume overload; Display risk of diuretic resistance, characterized by:; Daily loop-diuretics administration for a minimum of 7 days before admission, or; Insufficient decongestion observed in the preceding 24 hours (weight reduction <500g or negative fluid balance <1L) despite being treated with high-dose IV loop diuretic (equivalent to ≥120 mg IV furosemide within 24 hours); Clinical signs of congestion, indicated by one or more of the following: pitting peripheral edema, ascites, elevated jugular venous pressure, or radiological/ultrasonic evidence of pulmonary congestion.
Exclusion: Use of renal replacement therapy or ultrafiltration in-hospital before study inclusion; Treatment with acetazolamide or metolazone during the index hospitalization prior to randomization; Acute coronary syndrome; Known allergy to any of the used drugs; Severe hypokalemia (<2.5 mmol/l) or severe hyponatremia (<125 mmol/l); Severe hepatic impairment defined as an INR >1.5 (not due to anticoagulant therapy) and/or a Child-Pugh score ≥B7; Systolic blood pressure <85 mmHg; Known pregnancy.