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Can urine tests guide better diuretic dosing in heart failure?
NCT ID NCT05411991
First seen Sep 11, 2026 · Last updated Sep 11, 2026
Summary
Researchers are testing whether adjusting intravenous diuretic doses based on sodium levels in urine helps clear excess fluid more effectively than standard care in people hospitalized with acute heart failure. The trial enrolls adults with fluid overload and compares a strategy of measuring urine sodium after each diuretic dose, with low-threshold use of combination therapy, against usual treatment. The goal is to see if this approach improves survival, shortens hospital stays, and reduces heart failure markers without harming kidney function.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- intravenous bumetanide and acetazolamide, with dosing guided by urine sodium measurements
- What this could lead to
- If it works, this approach could help doctors clear excess fluid more effectively in hospitalized heart failure patients, potentially shortening hospital stays and reducing deaths.
- What could go wrong
- The strategy may not improve outcomes compared to usual care, and measuring urine sodium adds complexity. Diuretics can cause kidney problems or electrolyte imbalances.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
107 people
The number who actually took part.
- Started
-
Jun 2022
- Finished
-
Jul 2024
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 99 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion criteria: * At least 18 y/o and able to provide informed consent * Hospital admission (anticipated stay \>24 h after randomisation) with diagnosis of acute heart failure according to the treating physician * At least one of the following three signs of volume overload: 1. bilateral oedema 2+, indicating clear pitting 2. ascites that is amenable for drainage, confirmed by echography (no obligation to perform abdominal echocardiography, but necessary when presence of ascites is used as an entry criterion for the study) 3. uni- or bilateral pleural effusions that are amenable for drainage, confirmed by chest X-ray or lung ultrasound (no obligation to perform chest X-ray, but necessary when presence of pleural effusions is used as an entry criterion for the study) * Plasma NTproBNP level \>1,000 ng/L Exclusion criteria: * No possibility to collect reliable urine spot samples after diuretic administration * Administration of any diuretic within 6 h before randomisation, except for a mineralocorticoid receptor antagonist or sodium glucose co-transporter-2 inhibitor as part of the patient's maintenance treatment for heart failure. Patients can still be included after withholding these diuretics for 6 h, after which randomisation can be performed if they qualify all other criteria. * Severe kidney dysfunction, defined as an eGFR \<15 mL/min/1.73m² calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula and/or previous, current, or planned future renal replacement therapy * Systolic blood pressure \<90 mmHg, mean arterial pressure \<65 mmHg, or need for inotropes/vasopressor therapy at randomisation * Any acute coronary syndrome within 30 days prior to enrolment, defined as typical chest pain with a troponin rise above the 99th percentile of normal and/or electrocardiographic changes suggestive of cardiac ischemia * History of heart or kidney transplantation * History of mechanical circulatory support * Known obstructive hypertrophic cardiomyopathy, congenital heart disease, acute mechanical cause of acute heart failure (e.g., papillary muscular rupture), acute myocarditis, or constrictive pericarditis according to the treating physician * Pregnant or breastfeeding woman * Concomitant participation in another interventional study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Jessa Hospital
Hasselt, Limburg, 3500, Belgium
-
University Hospital Brussels
Jette, Brussels Capital, 1090, Belgium
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