Urinary Sodium and Chloride Changes and Fluid Overload in Acute Heart Failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter observational study enrolling adults hospitalized with acute heart failure who receive intravenous diuretics. Researchers will collect serial clinical data, blood and urine biomarkers, and echocardiographic measurements to track decongestion. The study will examine whether changes in urinary sodium and chloride align with fluid removal and with residual congestion at discharge, as well as the risk of worsening heart failure or death at 30 days and 3 months post-discharge. A multiparametric approach will be used to assess decongestion, incorporating clinical signs, imaging, and estimated plasma volume status. The planned minimum sample size is 223 patients to complete follow-up.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Provision of written informed consent prior to any study-related procedures;
* Age ≥ 18 years;
* Episode of AHF requiring hospital admission and treatment with intravenous furosemide;
* New York Heart Association (NYHA) functional class II-IV;
* NT-proBNP \>1000 pg/mL or BNP \>250 pg/mL, measured within a period not exceeding 24 hours prior to inclusion;
* Transthoracic echocardiogram performed within the previous 24 months. All LVEF categories will be included: reduced LVEF (\<40%), mildly reduced LVEF (41-49%), and preserved LVEF (≥50%). In patients with preserved LVEF (HFpEF), congruent structural and/or functional echocardiographic abnormalities are required (left ventricular hypertrophy defined as septal or posterior wall thickness ≥11 mm, E/e' \>9, or left atrial volume \>32 mL/m²);
* Signs of fluid overload, with at least two of the following: jugular venous distension (at least up to the sternocleidomastoid level, \~10 cm), lower limb edema, ascites, or pleural effusion confirmed by chest radiography or lung ultrasound
* Treatment with oral furosemide at a dose of at least 40 mg/day within the previous month.

Exclusion Criteria:

* Symptomatic hyponatremia or plasma sodium level ≤125 mmol/L;
* Hemoglobin \<9 g/dL;
* Hypokalemia: serum potassium \<3 mEq/L;
* Chronic kidney disease with estimated glomerular filtration rate (eGFR) \<15 mL/min/1.73 m²;
* Hemodynamic instability at admission, defined as symptomatic hypotension;
* Acute coronary syndrome, cardiogenic shock, or admission to the intensive care unit (ICU);
* Severe infection (e.g., pneumonia, sepsis, leukocyte count ≥12,000/μL, C-reactive protein \>50 mg/L, or positive COVID-19 test);
* Requirement for inotropic agents;
* Life expectancy \<3 months or, in the investigator's judgment, inability to comply with study procedures.

Where it's running

• Hospital Universitario Ramon y Cajal
  Madrid, Madrid, Spain Recruiting
• Hospital de Olot i Comarcal de la Garrotxa
  Olot, Girona, Spain Not yet recruiting
• Hospital Universitario Puerta de Hierro Majadahonda
  Majadahonda, Madrid, Spain Not yet recruiting
• Hospital Clínico Universitario de Valencia
  Valencia, Valencia, Spain Not yet recruiting

Study contacts

• Principal investigator: Pau Llàcer Iborra, MD PhD — Fundación para la Investigación Biomédica del Hospital Universitario Ramón y Cajal (FIBioHRC)
• Study coordinator: Pau Llàcer Iborra, MD PhD
• Email: paullacer@hotmail.com
• Phone: 0034 913368000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.