Urinary Chloride and Sodium Changes and Residual Congestion in Acute Heart Failure (CLORINA-IC)

May 19, 2026 updated by: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

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

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 Overview

Status

Not yet recruiting

Conditions

Detailed Description

This is a prospective, multicenter observational study. A minimum required sample size of n = 223 patients completing the study is planned. This study will include patients hospitalized for AHF and treated with intravenous diuretics. Clinical, biochemical, echocardiographic parameters, and circulating biomarkers (NT-proBNP, CA125, sST2, bioADM, and CD146) will be collected serially during hospitalization. Additionally, clinical events (worsening heart failure and/or all-cause mortality) will be recorded at 30 days and 3 months after discharge. Decongestion will be assessed using a multiparametric approach, incorporating clinical evaluation, echographic parameters, and estimated plasma volume status.

Study Type

Observational

Enrollment (Estimated)

223

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
    • Girona
      • Olot, Girona, Spain, 17800
        • Hospital de Olot i Comarcal de la Garrotxa
        • Contact:
    • Madrid
      • Madrid, Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal
        • Contact:
        • Contact:
        • Principal Investigator:
          • Pau Llacer Iborra, MD PhD
      • Majadahonda, Madrid, Spain, 28222
    • Valencia
      • Valencia, Valencia, Spain, 46010
        • Hospital Clínico Universitario de Valencia
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Residual Congestion at 72 Hours
Time Frame: 72 hours after admission.

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.
72 hours after admission.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Worsening Heart Failure at 30 days
Time Frame: From hospital discharge to 30 days thereafter.

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.
From hospital discharge to 30 days thereafter.
Worsening Heart Failure at 3 months
Time Frame: From hospital discharge to 3 months thereafter.

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.
From hospital discharge to 3 months thereafter.
30-day all-cause mortality
Time Frame: From hospital discharge to 30 days thereafter.
All-cause mortality 30 days after hospital discharge.
From hospital discharge to 30 days thereafter.
3-month all-cause mortality
Time Frame: From hospital discharge to 3 months thereafter.
All-cause mortality 3 months after hospital discharge.
From hospital discharge to 3 months thereafter.
30-day combined event (all-cause mortality or worsening heart failure)
Time Frame: From hospital discharge to 30 days thereafter.
All-cause mortality or worsening heart failure 30 days after hospital discharge.
From hospital discharge to 30 days thereafter.
3-month combined event (all-cause mortality or worsening heart failure)
Time Frame: From hospital discharge to 3 months thereafter.
All-cause mortality or worsening heart failure 3 months after hospital discharge.
From hospital discharge to 3 months thereafter.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Collaborators

Carlos III Health Institute

Investigators

  • Principal Investigator: Pau Llàcer Iborra, MD PhD, Fundación para la Investigación Biomédica del Hospital Universitario Ramón y Cajal (FIBioHRC)
  • Principal Investigator: Luis Manzano Espinosa, MDPhD, Hospital Universitario Ramon y Cajal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

May 13, 2026

First Submitted That Met QC Criteria

May 13, 2026

First Posted (Actual)

May 19, 2026

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI25/00126 (Other Grant/Funding Number: Instituto de Salud Carlos III (ISCIII))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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