Urine test could predict heart failure outcomes

NCT ID NCT07597512

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First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at 223 adults hospitalized with acute heart failure to see if changes in urine salt levels (sodium and chloride) can help doctors understand how well the body is getting rid of extra fluid. Participants will have blood and urine tests, heart ultrasounds, and check-ups after discharge. The goal is to find better ways to spot lingering fluid buildup and predict short-term risks like readmission or death.

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Study facts

What this study's own registry entry says, in plain language.

Participants

About 223 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hospital Clínico Universitario de Valencia

    Valencia, Valencia, 46010, Spain

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, Madrid, 28222, Spain

  • Hospital Universitario Ramon y Cajal

    Madrid, Madrid, 28034, Spain

  • Hospital de Olot i Comarcal de la Garrotxa

    Olot, Girona, 17800, Spain

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