NCT06166654RecruitingPhase 3
Optimal Diuretic Therapies for Acute Heart Failure With Volume Overload
Optimal Diuretic Therapies for Acute Heart Failure With Volume Overload - A Randomized Clinical Trial
Source: ClinicalTrials.gov · Last updated 27 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 939 (estimated)
- First submitted
- 3 Dec 2023
- Start date
- 5 Sept 2024
- Primary completion date
- 2 Mar 2028
- Lead sponsor
- Johannes Grand
- Diseases
- Heart failure
- NCT number
- NCT06166654
- EU CT number
- 2024-510633-17-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 939
- From 5 Sept 2024 to the primary completion date, 2 Mar 2028
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of renal replacement therapy or ultrafiltration in-hospital before study inclusion
- Treatment with acetazolamide or metolazone during the index hospitalization prior to randomization
Other illness
- Acute coronary syndrome
- Known allergy to any of the used drugs
Lab values
- 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
Other
- Systolic blood pressure \<85 mmHg
- Known pregnancy
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aarhus Universitetshospital Coordinator of this site? Confirm its status | Aarhus N | Denmark | Recruiting |
| Herlev Hospital Coordinator of this site? Confirm its status | Herlev | Denmark | Recruiting |
| Hvidovre Hospital Coordinator of this site? Confirm its status | Hvidovre | Denmark | Recruiting |
| Bispebjerg Hospital Coordinator of this site? Confirm its status | København | Denmark | Recruiting |
| Odense University Hospital Coordinator of this site? Confirm its status | Odense C | Denmark | Recruiting |
| Copenhagen University Hospital Coordinator of this site? Confirm its status | Roskilde | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.