NCT05411991CompletedPhase 4
Diuretic Treatment in Acute Heart Failure With Volume Overload Guided by Serial Spot Urine Sodium Assessment
Source: ClinicalTrials.gov · Last updated 11 Sept 2026
Brief summary (registry, in English)
This is a pragmatic, multicenter, interventional, parallel-arm, randomized, open-label trial to investigate whether a diuretic regimen, based on serial assessment of sodium concentration (UNa) on spot urine samples after diuretic administration and with low-threshold use of combination diuretic therapy, improves decongestion versus usual care in acute heart failure (AHF), potentially leading to better clinical outcomes.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 107 (actual)
- First submitted
- 6 Jun 2022
- Start date
- 12 Jun 2022
- Primary completion date
- 1 Jul 2024
- Lead sponsor
- Vrije Universiteit Brussel
- Diseases
- Heart failure
- NCT number
- NCT05411991
- EudraCT number
- 2021-005426-18
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 107
- From 12 Jun 2022 to the primary completion date, 1 Jul 2024
- 2 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
- 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
- Concomitant participation in another interventional study
Other illness
- 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
Lab values
- 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
Other
- No possibility to collect reliable urine spot samples after diuretic administration
- Pregnant or breastfeeding woman
Who the study is looking for
- 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:
- bilateral oedema 2+, indicating clear pitting
- 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)
- 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
Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Jessa Hospital Coordinator of this site? Confirm its status | Hasselt | Belgium | Unknown status |
| University Hospital Brussels Coordinator of this site? Confirm its status | Jette | Belgium | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.