Evaluating Residual Congestion at Discharge in Acute Heart Failure Patients

NCT06993220 | Recruiting

• 1 other identifier: 24/53
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Heart Failure (AHF); Congestive Heart Failure(CHF)

Keywords

acute heart failure; residual congestion; multiparametric assessment; risk stratification

Outcome Measures

Primary Outcomes (1)

• Worsening heart failure or cardiovascular death

  Occurrence of the composite of cardiovascular death and worsening heart failure (defined as unplanned hospitalization or urgent visit resulting in diuretic intravenous therapy)

  6 months after hospital discharge

Secondary Outcomes (3)

• all-cause death

  6 months after hospital discharge

• time to first heart failure event

  6 months after hospital discharge

• number of heart failure events

  6 months after hospital discharge

Study Arms (1)

Patients hospitalized for acute heart failure

Diagnostic Test: Evaluation of residual congestion at discharge

Interventions

Evaluation of residual congestion at discharge DIAGNOSTIC_TEST

Evaluation 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.

Patients hospitalized for acute heart failure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients hospitalized for acute heart failure

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Consorci Sanitari Integral: lead

Study Sites (1)

Complex Hospitalari Universitari Moisès Broggi

Sant Joan Despí, Barcelona, 08970, Spain

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Giosafat Spitaleri, M.D.

  Consorci Sanitari Integral

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giosafat Spitaleri, M.D.

CONTACT

+34 654471303; gspitaleri@csi.cat

Roman Freixa, M.D., Ph.D.

CONTACT

+34 935 53 12 00; roman.freixa@csi.cat

Study Design

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

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: May 28, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: July 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)