Clinical trial NCT06993220: Evaluating Residual Congestion at Discharge in Acute Heart Failure Patients
Official title: Multiparametric Assessment of Residual Congestion at Discharge in Patients With Acute Heart Failure
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Heart Failure (AHF)
Congestive Heart Failure(CHF)
Keywords: acute heart failure
residual congestion
multiparametric assessment
risk stratification
Lead sponsor: Consorci Sanitari Integral
Sponsor class: OTHER
First posted: 2025-05-28
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized for acute heart failure

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 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.


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.

Primary outcomes:
measure: Worsening heart failure or cardiovascular death
timeFrame: 6 months after hospital discharge
Secondary outcomes:
measure: all-cause death
timeFrame: 6 months after hospital discharge
measure: time to first heart failure event
timeFrame: 6 months after hospital discharge
measure: number of heart failure events
timeFrame: 6 months after hospital discharge
Other outcomes:
Locations:
city: Sant Joan Despí
country: Spain
facility: Complex Hospitalari Universitari Moisès Broggi
state: Barcelona
Study officials:
affiliation: Consorci Sanitari Integral
name: Giosafat Spitaleri, M.D.
role: PRINCIPAL_INVESTIGATOR
References: