Evaluating Residual Congestion at Discharge in Acute Heart Failure Patients

NCT ID: NCT06993220

Last Updated: 2025-07-18

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2027-01-01

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)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients hospitalized for acute heart failure

Evaluation of residual congestion at discharge

Intervention Type: 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.

Interventions

Evaluation of residual congestion at discharge

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years.
• Patients hospitalized for new onset heart failure or worsening heart failure defined by:

1. Symptoms classified as New York Heart Association class III or IV.

2. 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).

3. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Consorci Sanitari Integral

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Giosafat Spitaleri, M.D.

Role: PRINCIPAL_INVESTIGATOR

Consorci Sanitari Integral

Locations

Complex Hospitalari Universitari Moisès Broggi

Sant Joan Despí, Barcelona, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Giosafat Spitaleri, M.D.

Role: CONTACT

gspitaleri@csi.cat

+34 654471303

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

Role: CONTACT

roman.freixa@csi.cat

+34 935 53 12 00

Facility Contacts

Giosafat Spitaleri, M.D.

Role: primary

gspitaleri@csi.cat

+34654471303

Other Identifiers

24/53

Identifier Type: -

Identifier Source: org_study_id