Evaluating Residual Congestion at Discharge in Acute Heart Failure Patients

Consorci Sanitari Integral

Status: Enrolling

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

Treatments: Diagnostic Test: Evaluation of residual congestion at discharge

Study type: Observational

Funder types: Other

Identifiers

NCT06993220

24/53

Details and patient eligibility

About

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 our study is to assess residual congestion at discharge using a multiparametric approach and to compare the prognostic value of each evaluation strategy. Additionally, our 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

500 participants in 1 patient group

Patients hospitalized for acute heart failure

Treatment:

Diagnostic Test: Evaluation of residual congestion at discharge