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RecruitingNCT06993220Updated Jul 18, 2025

Evaluating Residual Congestion at Discharge in Acute Heart Failure Patients

An observational study in Acute Heart Failure (AHF) and Congestive Heart Failure(CHF), sponsored by Consorci Sanitari Integral. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-18.

Sponsored by Consorci Sanitari Integral · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2026, 4 months ago, but the record still lists the study as recruiting.
  • Started Jan 2025; still recruiting 1 year 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

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

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Keywords

  • acute heart failure
  • residual congestion
  • multiparametric assessment
  • risk stratification
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's planned enrollment of 500 is above the median of 200 across 1,679 observational studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Consorci Sanitari Integral is the lead sponsor of 16 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients hospitalized for acute heart failure

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients hospitalized for acute heart failure

    Diagnostic Test: Evaluation of residual congestion at discharge

Interventions

  • Diagnostic testEvaluation 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.

06

What researchers measure

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)

    Time frame: 6 months after hospital discharge

Secondary outcomes

  1. all-cause death

    Time frame: 6 months after hospital discharge

  2. time to first heart failure event

    Time frame: 6 months after hospital discharge

  3. number of heart failure events

    Time frame: 6 months after hospital discharge

07

Study locations

1 of 1 sites recruiting
  • Complex Hospitalari Universitari Moisès Broggi
    Sant Joan Despí, Barcelona 08970, Spain
    • Giosafat Spitaleri, M.D. · Contact · gspitaleri@csi.cat · +34654471303
    • Giosafat Spitaleri, M.D. · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06993220
Lead sponsor
Consorci Sanitari Integral
Responsible party
Sponsor
First posted
May 28, 2025
Start date
Jan 1, 2025
Primary completion
Jun 1, 2026 (estimated)
Completion
Jan 1, 2027 (estimated)
Last update
Jul 18, 2025

Study contacts

Giosafat Spitaleri, M.D.
Contact
gspitaleri@csi.cat
+34 654471303
Roman Freixa, M.D., Ph.D.
Contact
roman.freixa@csi.cat
+34 935 53 12 00
Giosafat Spitaleri, M.D.
principal investigator · Consorci Sanitari Integral

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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