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NCT07597512From ClinicalTrials.govRecruiting

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

Association of Urinary Chloride and Sodium Dynamics With Multiparametrically Assessed Residual Congestion in Acute Heart Failure (CLORINA-IC)

  • Acute Heart Failure (AHF)
  • Heart Failure
  • Congestion

At a glance

Phase
Phase not stated
Study type
Observational
Sponsor
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Enrolment target
223
Started
6 May 2026
Main results due
31 December 2028
Study sites
4
Registry updated
28 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
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.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(4)

  • Hospital de Olot i Comarcal de la Garrotxa

    Olot, Girona, Spain

    Not yet recruiting

  • Hospital Universitario Ramon y Cajal

    Madrid, Madrid, Spain

    Recruiting

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, Madrid, Spain

    Not yet recruiting

  • Hospital Clínico Universitario de Valencia

    Valencia, Valencia, Spain

    Not yet recruiting

Showing 4 of 4 sites. 1 of the 4 sites on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07597512. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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