About this trial
The goal of this observational study is to learn how changes in urinary sodium and chloride levels relate to fluid overload and short-term outcomes in patients hospitalized with acute heart failure (AHF). The main questions it aims to answer are:
* Do changes over time in urinary sodium and chloride reflect how well excess fluid is being removed during hospitalization? * Are these changes associated with residual congestion at discharge and with the risk of worsening heart failure or death after discharge?
Participants hospitalized for AHF and treated with intravenous diuretics as part of their usual care will have clinical assessments, blood and urine tests, and echocardiographic evaluations collected at several time points during their hospital stay. Researchers will also record clinical outcomes, including worsening heart failure or death, at 30 days and 3 months after discharge.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial population
Adult patients of both sexes hospitalized for acute heart failure (AHF) in Internal Medicine and Cardiology departments at Spanish hospitals, presenting with signs of fluid overload and receiving intravenous (IV) diuretic therapy. The clinical diagnosis of heart failure will be established based on the presence of typical signs and symptoms, evidence of underlying structural heart disease on transthoracic echocardiography performed within the previous 24 months, and elevated natriuretic peptides measured at least 24 hours prior to inclusion. Patients across the full spectrum of left ventricular ejection fraction (LVEF) will be included.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Residual Congestion at 72 Hours
Residual Congestion 72 hours after admission, defined as the presence of any of the following criteria: i) Congestion Clinical Score (CCS) ≥ 2; ii) Portal venous flow pulsatility \> 30%; iii) Estimated plasma volume status (ePVS) \> 5.5 mL/g.
Secondary outcomes
Worsening Heart Failure at 30 days
Worsening Heart Failure 30 days after hospital discharge, defined as any of the following: i) Hospital readmission for heart failure; ii) Emergency department visits for heart failure; iii) Visits to the heart failure unit requiring intravenous diuretic administration.
Worsening Heart Failure at 3 months
Worsening Heart Failure 3 months after hospital discharge, defined as any of the following: i) Hospital readmission for heart failure; ii) Emergency department visits for heart failure; iii) Visits to the heart failure unit requiring intravenous diuretic administration.
30-day all-cause mortality
All-cause mortality 30 days after hospital discharge.
3-month all-cause mortality
All-cause mortality 3 months after hospital discharge.
Sponsors and contacts
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Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Lead sponsor
Carlos III Health Institute
Collaborator