Complex Hospitalari Universitari Moisès Broggi
Sant Joan Despí, Barcelona, 08970, Spain
Location status: Recruiting
Location contact
Giosafat Spitaleri, M.D.
CONTACT
Giosafat Spitaleri, M.D.
PRINCIPAL_INVESTIGATOR
Recruiting
NCT Number: NCT06993220
Evaluating Residual Congestion at Discharge in Acute Heart Failure Patients
Treatment of congestion is one of the main goals in patients hospitalized for acute heart failure. Nevertheless, current evidence shows that decongestion is often not achieved and that residual congestion at discharge is strongly associated with poor outcomes. While this association has been demonstrated, previous studies have primarily focused on single parameters of congestion (physical examination, biomarkers, or imaging features). The aim of the study is to assess residual congestion at discharge using a multiparametric approach and to compare the prognostic value of each evaluation strategy. Additionally, the analysis will be supported by artificial intelligence to develop a multiparametric prognostic algorithm that can provide an improved predictive model compared to standard statistical approaches.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Age ≥ 18 years.
- Patients hospitalized for new onset heart failure or worsening heart failure defined by:
- Symptoms classified as New York Heart Association class III or IV.
- Clinical or instrumental signs of volume overload (e.g., dyspnea with evidence of pulmonary congestion on X-rays or lung ultrasound, pitting edema, and jugular venous distension).
- Elevated NT-proBNP levels within the first 24 hours of admission (cutoff values: 450 ng/L for patients < 50 years; >900 ng/L for patients aged 50-75 years; >1800 ng/L for patients >75 years).
- Ability to provide informed consent.
Exclusion criteria
- Known diagnosis of septicemia.
- Glomerular filtration rate < 15 ml/min.
- Life expectancy < 6 months.
- Active myocarditis.
- Heart transplant recipients.
- Patients with ventricular assist devices.
- Congenital heart diseases.
- Moderate-to-severe liver disease (Child-Pugh B-C).
- Patients that will not be followed up by the Heart Failure Unit.
Treatment and study plan
Evaluation of residual congestion at discharge
Diagnostic TestEvaluation of residual congestion at discharge will be made using:
- Clinical variables: composite congestion score calculated by summing the individual scores for orthopnoea, jugular venous distension and pedal oedema;
- Imaging variables: non-invasive left ventricular filling pressure, number of LUS B lines and the presence of pleural effusion, Venous Excess UltraSound (VExUS) score;
- Laboratory variables: hemoglobin and hematocrit, NT-proBNP, CA-125, ST2, troponin T, creatinine, AST, ALT, Na, K, urea, bilirubin, C-reactive protein.
Primary outcomes
-
Worsening heart failure or cardiovascular death
Time frame: 6 months after hospital discharge
Occurrence of the composite of cardiovascular death and worsening heart failure (defined as unplanned hospitalization or urgent visit resulting in diuretic intravenous therapy)
Secondary outcomes
-
all-cause death
Time frame: 6 months after hospital discharge
-
time to first heart failure event
Time frame: 6 months after hospital discharge
-
number of heart failure events
Time frame: 6 months after hospital discharge
Study contacts
Contact information is provided by the study sponsor or research team.
Giosafat Spitaleri, M.D.
CONTACT
Roman Freixa, M.D., Ph.D.
CONTACT
Sponsors and collaborators
Lead sponsor
Consorci Sanitari Integral
Other
Registry information
Official study title
Multiparametric Assessment of Residual Congestion at Discharge in Patients With Acute Heart Failure
Important dates
- Study start
- 2025
- Primary completion
- 2026
- Study completion
- 2027
- First posted
- May 28, 2025
- Registry last updated
- Jul 18, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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