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| ID | Type | Description | Link |
|---|---|---|---|
| PI25/00126 | Other Grant/Funding Number | Instituto de Salud Carlos III (ISCIII) |
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| Name | Class |
|---|---|
| Carlos III Health Institute | OTHER_GOV |
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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:
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.
This is a prospective, multicenter observational study. A minimum required sample size of n = 223 patients completing the study is planned. This study will include patients hospitalized for AHF and treated with intravenous diuretics. Clinical, biochemical, echocardiographic parameters, and circulating biomarkers (NT-proBNP, CA125, sST2, bioADM, and CD146) will be collected serially during hospitalization. Additionally, clinical events (worsening heart failure and/or all-cause mortality) will be recorded at 30 days and 3 months after discharge. Decongestion will be assessed using a multiparametric approach, incorporating clinical evaluation, echographic parameters, and estimated plasma volume status.
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Worsening Heart Failure at 30 days | Worsening Heart Failure 30 days after hospital discharge, defined as any of the following: i) Hospital readmission for heart failure; ii) Emergency department visits for heart failure; iii) Visits to the heart failure unit requiring intravenous diuretic administration. | From hospital discharge to 30 days thereafter. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pau Llàcer Iborra, MD PhD | Contact | 0034 913368000 | paullacer@hotmail.com | |
| Cristina Fernández Soler | Contact | 0034 913368000 | cfsoler@salud.madrid.org |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Olot i Comarcal de la Garrotxa | Olot | Girona | 17800 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41078081 | Background | 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. |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Serum and plasma
| Worsening Heart Failure at 3 months | Worsening Heart Failure 3 months after hospital discharge, defined as any of the following: i) Hospital readmission for heart failure; ii) Emergency department visits for heart failure; iii) Visits to the heart failure unit requiring intravenous diuretic administration. | From hospital discharge to 3 months thereafter. |
| 30-day all-cause mortality | All-cause mortality 30 days after hospital discharge. | From hospital discharge to 30 days thereafter. |
| 3-month all-cause mortality | All-cause mortality 3 months after hospital discharge. | From hospital discharge to 3 months thereafter. |
| 30-day combined event (all-cause mortality or worsening heart failure) | All-cause mortality or worsening heart failure 30 days after hospital discharge. | From hospital discharge to 30 days thereafter. |
| 3-month combined event (all-cause mortality or worsening heart failure) | All-cause mortality or worsening heart failure 3 months after hospital discharge. | From hospital discharge to 3 months thereafter. |
| Hospital Universitario Ramon y Cajal | Madrid | Madrid | 28034 | Spain |
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| Hospital Universitario Puerta de Hierro Majadahonda | Majadahonda | Madrid | 28222 | Spain |
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| Hospital Clínico Universitario de Valencia | Valencia | Valencia | 46010 | Spain |
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