Acute Heart Failure (AHF), Congestion, Heart Failure
Conditions
Keywords
Acute Heart Failure, Heart failure, Biomarkers, Congestion, Urinary chloride, Urinary sodium, Diuretics, point of care ultrasound, POCUS
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.
Detailed description
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.
Interventions
None listed
Sponsors
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Carlos III Health Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Worsening Heart Failure at 30 days | From hospital discharge to 30 days thereafter. | 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. |
| Worsening Heart Failure at 3 months | From hospital discharge to 3 months thereafter. | 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. |
| 30-day all-cause mortality | From hospital discharge to 30 days thereafter. | All-cause mortality 30 days after hospital discharge. |
| 3-month all-cause mortality | From hospital discharge to 3 months thereafter. | All-cause mortality 3 months after hospital discharge. |
| 30-day combined event (all-cause mortality or worsening heart failure) | From hospital discharge to 30 days thereafter. | All-cause mortality or worsening heart failure 30 days after hospital discharge. |
| 3-month combined event (all-cause mortality or worsening heart failure) | From hospital discharge to 3 months thereafter. | All-cause mortality or worsening heart failure 3 months after hospital discharge. |
Countries
Spain
Contacts
CONTACTPau Llàcer Iborra, MD PhD
CONTACTCristina Fernández Soler
PRINCIPAL_INVESTIGATORPau Llàcer Iborra, MD PhD
Fundación para la Investigación Biomédica del Hospital Universitario Ramón y Cajal (FIBioHRC)
PRINCIPAL_INVESTIGATORLuis Manzano Espinosa, MDPhD
Hospital Universitario Ramón y Cajal
Outcome results
None listed