Not Yet RecruitingNot Applicable

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

Spain223 participantsStarted 2026-05

Plain-language 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). 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 synd…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This study is focused on measuring 'residual congestion' at 72 hours — can you explain what that means for someone with acute heart failure, and why it matters whether fluid is still present after three days of treatment?
2Since this trial is tracking changes in urinary chloride and sodium levels, what would that kind of monitoring actually involve day-to-day, and is that level of urine testing something I'd need to be in a hospital for?
3The trial isn't recruiting yet — given my current situation with acute heart failure, is waiting for this study to open realistic, or should we be focused on a treatment plan right now?
4This is listed as a Phase N/A observational-style study rather than a drug trial — does that mean there's no experimental treatment involved, and if so, what would actually be different about my care compared to standard treatment?
5Are there already established ways my care team uses urine electrolyte levels like sodium and chloride to guide my diuretic treatment, and how might what this study is investigating change how that's done in the future?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Residual Congestion at 72 Hours

Timeframe: 72 hours after admission.

Trial details

NCT IDNCT07597512

SponsorFundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-12-31

Contact for this trial

Pau Llàcer Iborra, MD PhD

0034 913368000 paullacer@hotmail.com

View on ClinicalTrials.gov More Acute Heart Failure (AHF) trials