UNLOAD-CHF Urea for Normalizing hyponatremia and reducing voLume Overload in Acute and Chronic Heart Failure
Key facts
- Where
- L'hospitalet De Llobregat, Madrid, Málaga, Sevilla, Vigo és Viladecans, SpanyolországSee the 7 sites
- Phase
- 3. fázis
Where in Spanyolország
- Consorci Sanitari IntegralL'hospitalet De Llobregat, SpanyolországToborzás még nem indult
- Hospital General Universitario Gregorio MarañónMadrid, SpanyolországToborzás még nem indult
- Hospital Universitario Regional de MálagaMálaga, SpanyolországToborzás még nem indult
- Hospital Universitario Virgen De ValmeSevilla, SpanyolországToborzás még nem indult
- University Hospital Virgen Del Rocio S.L.Sevilla, SpanyolországToborzás még nem indult
- Hospital Alvaro CunqueiroVigo, SpanyolországToborzás még nem indult
- Hospital de ViladecansViladecans, SpanyolországToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Nutricion Medica S.L.
- Trial code
- EU 2025-523981-26-03
- Record updated
- 2026. november 5.
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: 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; Terminal illness/agony; Renal disease with an estimated glomerular filtration rate < 30 ml/min/m2; Chronic liver disease in Child-Pugh C liver cirrhosis; 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; 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.