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Can urine tests guide better diuretic dosing in heart failure?

NCT ID NCT05411991

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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

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

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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