Observational Recruiting
NCT07597512 on ClinicalTrials.gov
Urinary Chloride and Sodium Changes and Residual Congestion in Acute Heart Failure
Official title: Association of Urinary Chloride and Sodium Dynamics With Multiparametrically Assessed Residual Congestion in Acute Heart Failure (CLORINA-IC)
- Sponsor: Hospital Universitario Ramón y Cajal
- Collaborators: Carlos III Health Institute
- Enrollment: 223 (Estimated)
- Study start: 2026-05-06 (Actual)
- Primary completion: 2028-12-31 (Estimated)
- Study completion: 2028-12-31 (Estimated)
- Allocation: N/a
- InterventionModel: N/a
- Masking: None
- PrimaryPurpose: Other
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.
Conditions
- Acute Heart Failure (AHF)
- Heart Failure
- Congestion
Primary Outcome Measures
-
Residual Congestion at 72 Hours
(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.
Countries
Spain
Locations and Investigators
-
Hospital de Olot i Comarcal de la Garrotxa, Olot, Spain (Not yet recruiting)
- Joan Carles Trullas
-
Hospital Universitario Ramon y Cajal, Madrid, Spain (Recruiting)
- Pau Llà cer Iborra, MD PhD
- Cristina Fernandez Soler
- Pau Llacer Iborra, MD PhD (Principal Investigator)
-
Hospital Universitario Puerta de Hierro Majadahonda, Majadahonda, Spain (Not yet recruiting)
- Marta Cobo
-
Hospital ClÃnico Universitario de Valencia, Valencia, Spain (Not yet recruiting)
- Sandra Villar
Study Officials
- Pau Llà cer 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