Acute Heart Failure (AHF)CLORINA-ICNCT07597512
Urinary Chloride and Sodium Changes and Residual Congestion in Acute Heart Failure
An observational study of Acute Heart Failure (AHF) and Heart Failure, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 4 sites in Spain.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Heart Failure (AHF), Heart Failure, Congestion
- How many people
- 223 participants
- Where
- 4 sitesSpain
- Study dates
- 6 May 2026to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Cristina Fernández Soler contact
Spain4 sites, 4 recruiting
- Recruiting
Hospital Universitario Ramon y Cajal
Madrid, Madrid, 28034
Pau Llàcer Iborra, MD PhD, 0034913368000, paullacer@hotmail.com
Cristina Fernandez Soler, 0034913368000, cfsoler@salud.madrid.org
- Not yet recruiting
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, 28222
Marta Cobo, 0034 911916000, atepac.hpth@salud.madrid.org
- Not yet recruiting
Hospital de Olot i Comarcal de la Garrotxa
Olot, Girona, 17800
Joan Carles Trullas, 0034 972275200, direccio@hospiolot.com
- Not yet recruiting
Hospital Clínico Universitario de Valencia
Valencia, Valencia, 46010
Sandra Villar, 0034 9619735 00, hclinico_saip@gva.es
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Heart Failure (AHF), Heart Failure, Congestion
- Keywords
- Acute Heart Failure, Heart failure, Biomarkers, Congestion, Urinary chloride, Urinary sodium, Diuretics, point of care ultrasound, POCUS
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
Residual Congestion at 72 Hours
Residual Congestion 72 hours after admission, defined as the presence of any of the following criteria:
- Congestion Clinical Score (CCS) ≥ 2; ii) Portal venous flow pulsatility > 30%; iii) Estimated plasma volume status (ePVS) > 5.5 mL/g.
Measured: 72 hours after admission.
Secondary outcomes (6)
Worsening Heart Failure at 30 days
Worsening Heart Failure 30 days after hospital discharge, defined as any of the following:
- Hospital readmission for heart failure; ii) Emergency department visits for heart failure; iii) Visits to the heart failure unit requiring intravenous diuretic administration.
Measured: From hospital discharge to 30 days thereafter.
Worsening Heart Failure at 3 months
Worsening Heart Failure 3 months after hospital discharge, defined as any of the following:
- Hospital readmission for heart failure; ii) Emergency department visits for heart failure; iii) Visits to the heart failure unit requiring intravenous diuretic administration.
Measured: From hospital discharge to 3 months thereafter.
30-day all-cause mortality
All-cause mortality 30 days after hospital discharge.
Measured: From hospital discharge to 30 days thereafter.
3-month all-cause mortality
All-cause mortality 3 months after hospital discharge.
Measured: From hospital discharge to 3 months thereafter.
30-day combined event (all-cause mortality or worsening heart failure)
All-cause mortality or worsening heart failure 30 days after hospital discharge.
Measured: From hospital discharge to 30 days thereafter.
3-month combined event (all-cause mortality or worsening heart failure)
All-cause mortality or worsening heart failure 3 months after hospital discharge.
Measured: From hospital discharge to 3 months thereafter.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start6 May 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Heart Failure (AHF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 223 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Sponsor type
- University, hospital or other
- Collaborators
- Carlos III Health Institute
- Responsible party
- Sponsor
- Investigators
- Pau Llàcer Iborra, MD PhD, Principal investigator, Fundación para la Investigación Biomédica del Hospital Universitario Ramón y Cajal (FIBioHRC)Luis Manzano Espinosa, MDPhD, Principal investigator, Hospital Universitario Ramon y Cajal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07597512
- Sponsor's protocol ID
- PI25/00126
- Other IDs
- PI25/00126
- Acronym
- CLORINA-IC
- Status last verified
- Sep 2026
- First submitted
- 13 May 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Campos J, Llacer P, Croset F, Garcia M, Perez C, Perez A, Vergara M, Cevallos P, Fabregate M, Fernandez C, Ruiz R, Useros D, Menacho M, Dominguez M, Perez E, Nunez J, Manzano L. Dynamics of urinary chloride and sodium and their link to decongestion in acute heart failure and preserved ejection fraction: NACLOCRo-HF study. ESC Heart Fail. 2025 Dec;12(6):4336-4348. doi: 10.1002/ehf2.15436. Epub 2025 Oct 13.
PubMed 41078081
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Urinary Chloride and Sodium Dynamics With Multiparametrically Assessed Residual Congestion in Acute Heart Failure (CLORINA-IC)
- ClinicalTrials.gov ID
- NCT07597512
- Acronym / sponsor ID
- CLORINA-IC / PI25/00126
- Conditions
- Acute Heart Failure (AHF), Heart Failure, Congestion
- Keywords
- Acute Heart Failure, Heart failure, Biomarkers, Congestion, Urinary chloride, Urinary sodium, Diuretics, point of care ultrasound
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 223 participants (estimated)
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y CajalUniversity, hospital or other
- Collaborators
- Carlos III Health Institute
- Study start
- 6 May 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 19 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
6 secondary outcomes
Worsening Heart Failure at 30 days
Time frame: From hospital discharge to 30 days thereafter.
Worsening Heart Failure at 3 months
Time frame: From hospital discharge to 3 months thereafter.
30-day all-cause mortality
Time frame: From hospital discharge to 30 days thereafter.
3-month all-cause mortality
Time frame: 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.
3-month combined event (all-cause mortality or worsening heart failure)
Time frame: From hospital discharge to 3 months thereafter.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Background: PubMed 41078081Campos J, Llacer P, Croset F, Garcia M, Perez C, Perez A, Vergara M, Cevallos P, Fabregate M, Fernandez C, Ruiz R, Useros D, Menacho M, Dominguez M, Perez E, Nunez J, Manzano L. Dynamics of urinary chloride and sodium and their link to decongestion in acute heart failure and preserved ejection fraction: NACLOCRo-HF study. ESC Heart Fail. 2025 Dec;12(6):4336-4348. doi: 10.1002/ehf2.15436. Epub 2025 Oct 13.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cristina Fernández Soler contact
Pau Llàcer Iborra, MD PhD principal investigator
Fundación para la Investigación Biomédica del Hospital Universitario Ramón y Cajal (FIBioHRC)
Luis Manzano Espinosa, MDPhD principal investigator
Hospital Universitario Ramon y Cajal
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Heart Failure (AHF) and Heart Failure, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 4 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pau Llàcer Iborra, MD PhD (0034 913368000, paullacer@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Residual Congestion at 72 Hours (time frame: 72 hours after admission.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07597512, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.