Urinary Chloride and Sodium Changes and Residual Congestion in Acute Heart Failure

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
72 hours after admission.

Secondary outcomes

1

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.

Time frame
From hospital discharge to 30 days thereafter.
2

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.

Time frame
From hospital discharge to 3 months thereafter.
3

30-day all-cause mortality

All-cause mortality 30 days after hospital discharge.

Time frame
From hospital discharge to 30 days thereafter.
4

3-month all-cause mortality

All-cause mortality 3 months after hospital discharge.

Time frame
From hospital discharge to 3 months thereafter.

Other outcomes

Sponsors and contacts

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