2025-523981-26-03Not yet recruitingPhase 3
UNLOAD-CHF Urea for Normalizing hyponatremia and reducing voLume Overload in Acute and Chronic Heart Failure
Source: EU CTIS (euclinicaltrials.eu) · Last updated 5 Nov 2026
Brief summary (registry, in English)
To determine whether oral urea (15 g/day or 30 g/day), compared with placebo: Reduces the composite of Cardiovascular mortality and/or the need for hospital care due to heart failure at 90 days. And to determine whether oral urea (15 g/day or 30 g/day), compared with placebo achieves correction of hyponatremia (serum sodium ≥135 mmol/L) at Day 15 and Day 90.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 210 (estimated)
- First submitted
- 13 Jul 2026
- Start date
- 1 Sept 2026
- Lead sponsor
- Nutricion Medica S.L.
- Diseases
- Heart failure
- EU CT number
- 2025-523981-26-03
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 210
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with heart failure who are retaining fluid and have low blood sodium. It tests oral urea against placebo.
- Age
- Over 18 years
- Sex
- All sexes
- Disease stage
- Heart failure of any cause, with any LVEF, with fluid overload from acute decompensation (oedema, pleural effusion, lung congestion or ascites), needing hospital care or close monitoring in an advanced heart failure unit. Plasma sodium below 135 mmol/L.
- Earlier treatment
- Long-term furosemide, at least 80 mg by mouth or equivalent. Cannot have taken oral urea in the 3 months before admission or randomisation.
- Biomarker or test result
- Plasma sodium < 135 mmol/L. NT-proBNP must not be below 350 pg/mL.
Main reasons for not taking part
- Shock, need for inotropes or ventricular assist devices, or need for intubation at admission
- Kidney disease with eGFR < 30 ml/min/m2, or plasma urea ≥ 150 mg/dL
- Child-Pugh C liver cirrhosis
- Terminal illness, or known allergy, intolerance or contraindication to urea
- Taking part in another clinical trial, or continuing thiazide treatment
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with oral urea for 3 months prior to admission/randomisation.
- Patients who will continue treatment with thiazides after inclusion in the study
- Well-documented previous allergy and/or intolerance and/or contraindication to the use of urea
Other illness
- Terminal illness/agony
- Renal disease with an estimated glomerular filtration rate < 30 ml/min/m2
- Chronic liver disease in Child-Pugh C liver cirrhosis.
Lab values
- Blood glucose > 250 mg/dL, or 180-250 mg/dL together with serum sodium of 133-135 mEq/L at the time of admission.
- Plasma urea ≥ 150 mg/dL.
Other
- Clinical instability at admission, defined by: Cardiogenic/distributive shock, with systolic blood pressure < 90 mmHg and mean arterial pressure < 65 mmHg.; Need for inotropes or ventricular assist devices and Need for orotracheal intubation.
- Participation in other clinical trials at the time of randomisation.
- Any patient characteristic that may interfere with adherence to the study protocol or follow-up, such as lack of social support, substance abuse, or the inability of the patient/family member to understand the information and sign the study informed consent form (Appendix I. Information Sheet and Informed Consent Form).
- NT-proBNP levels < 350 pg/mL.
- History or situation of uraemic encephalopathy on admission
Who the study is looking for
- Heart failure, of any aetiology, regardless of LVEF, requiring hospitalisation or outpatient management with close monitoring in an advanced heart failure unit due to acute decompensation in a hypervolaemic situation, characterised by the presence of oedema, pleural effusion, pulmonary congestion or ascites, clinically demonstrated by chest X-ray or ultrasound.
- Chronic treatment with furosemide, at least 80 mg orally or equivalent, regardless of the use of other diuretics
- Plasma sodium < 135 mmol/L
- Individuals over 18 years of age who agree to participate in the study by signing an informed consent form approved by the Ethics Committee.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Consorci Sanitari Integral | L'hospitalet De Llobregat | Spain | Not yet recruiting |
| Hospital General Universitario Gregorio Marañón | Madrid | Spain | Not yet recruiting |
| Hospital Universitario Regional de Málaga | Málaga | Spain | Not yet recruiting |
| University Hospital Virgen Del Rocio S.L. | Sevilla | Spain | Not yet recruiting |
| Hospital Universitario Virgen De Valme | Sevilla | Spain | Not yet recruiting |
| Hospital Alvaro Cunqueiro | Vigo | Spain | Not yet recruiting |
| Hospital de Viladecans | Viladecans | Spain | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.