NCT07597512

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
223

participants targeted

Target at P75+ for all trials

Timeline
32mo left

Started May 2026

Typical duration for all trials

Geographic Reach
1 country

4 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
May 2026Dec 2028

Study Start

First participant enrolled

May 1, 2026

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

May 13, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 19, 2026

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

2.7 years

First QC Date

May 13, 2026

Last Update Submit

May 19, 2026

Conditions

Acute Heart Failure (AHF)Heart FailureCongestion

Keywords

Acute Heart FailureHeart failureBiomarkersCongestionUrinary chlorideUrinary sodiumDiureticspoint of care ultrasoundPOCUS

Outcome Measures

Primary Outcomes (1)

  • Residual Congestion at 72 Hours

    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 Outcomes (6)

  • Worsening Heart Failure at 30 days

    From hospital discharge to 30 days thereafter.

  • Worsening Heart Failure at 3 months

    From hospital discharge to 3 months thereafter.

  • 30-day all-cause mortality

    From hospital discharge to 30 days thereafter.

  • 3-month all-cause mortality

    From hospital discharge to 3 months thereafter.

  • 30-day combined event (all-cause mortality or worsening heart failure)

    From hospital discharge to 30 days thereafter.

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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;
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hospital de Olot i Comarcal de la Garrotxa

Olot, Girona, 17800, Spain

Location

Hospital Universitario Ramon y Cajal

Madrid, Madrid, 28034, Spain

Location

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Madrid, 28222, Spain

Location

Hospital Clínico Universitario de Valencia

Valencia, Valencia, 46010, Spain

Location

Related Publications (1)

  • 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.

    PMID: 41078081BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and plasma

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • 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 Ramón y Cajal

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pau Llàcer Iborra, MD PhD

CONTACT

0034 913368000paullacer@hotmail.com

Cristina Fernández Soler

CONTACT

cfsoler@salud.madrid.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2026

First Posted

May 19, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

May 22, 2026

Record last verified: 2026-05

Locations

ES(4)