NCT07597512Recruiting
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)
Source: ClinicalTrials.gov · Last updated 28 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 223 (estimated)
- First submitted
- 13 May 2026
- Start date
- 6 May 2026
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Diseases
- Heart failure
- NCT number
- NCT07597512
What you commit to
- Study type: Observational
- Planned participants: 223
- From 6 May 2026 to the primary completion date, 31 Dec 2028
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Acute coronary syndrome, cardiogenic shock, or admission to the intensive care unit (ICU);
Lab values
- 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;
- Severe infection (e.g., pneumonia, sepsis, leukocyte count ≥12,000/μL, C-reactive protein \>50 mg/L, or positive COVID-19 test);
Other
- Hemodynamic instability at admission, defined as symptomatic hypotension;
- Requirement for inotropic agents;
- Life expectancy \<3 months or, in the investigator's judgment, inability to comply with study procedures.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Puerta de Hierro - Majadahonda Coordinator of this site? Confirm its status | Majadahonda | Spain | Not yet recruiting |
| Hospital de Olot i Comarcal de la Garrotxa Coordinator of this site? Confirm its status | Olot | Spain | Not yet recruiting |
| Hospital Clinico Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.