Actively Recruiting

Age: 18Years +
All Genders
ID06993220

Multiparametric Assessment of Residual Congestion at Discharge in Patients With Acute Heart Failure

Led by Consorci Sanitari Integral · Updated on 2025-07-18

500

Participants Needed

1

Research Sites

30 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the presence of remaining fluid buildup, known as residual congestion, in patients hospitalized for acute heart failure. The study aims to assess this condition at the time of hospital discharge using multiple methods and compare how well each method predicts patient outcomes. Artificial intelligence will also be used to develop a new predictive model that may improve on standard approaches. The study involves measuring residual congestion through clinical signs such as orthopnea, jugular venous distension, and leg swelling; imaging tests including non-invasive heart pressure measurements, lung ultrasound, and venous excess ultrasound scores; and laboratory tests of various blood markers like NT-proBNP, hemoglobin, and others. All assessments are made at discharge to gather comprehensive data on fluid overload. Participants will be monitored for up to six months after leaving the hospital. During this time, researchers will track worsening heart failure, cardiovascular death, other heart failure events, and overall survival. The study includes regular evaluations of clinical signs, imaging, and laboratory tests to understand which evaluation methods best predict patient outcomes and to support the development of the new AI-based prognostic tool.

CONDITIONS

Brief Title

Evaluating Residual Congestion at Discharge in Acute Heart Failure Patients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Hospitalized for new or worsening heart failure with NYHA class III or IV symptoms
  • Clinical or imaging signs of fluid overload such as pulmonary congestion, leg swelling, or jugular venous distension
  • Elevated NT-proBNP levels within 24 hours of admission according to age-specific cutoffs
  • Ability to provide informed consent
Not Eligible

You will not qualify if you...

  • Known diagnosis of septicemia
  • Glomerular filtration rate less than 15 ml/min
  • Life expectancy less than 6 months
  • Active myocarditis
  • Heart transplant recipients
  • Patients with ventricular assist devices
  • Congenital heart diseases
  • Moderate to severe liver disease (Child-Pugh B or C)
  • Patients not followed up by the Heart Failure Unit

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - At hospital discharge

Participants undergo an evaluation of residual congestion at discharge using clinical, imaging, and laboratory assessments.

1 visit (in-person)

Long-term Monitoring

Duration - 6 months

Participants are monitored for worsening heart failure events, cardiovascular death, and other outcomes for 6 months after hospital discharge.

Periodic visits over 6 months as per routine care

Trial Site Locations

Total: 1 location

1

Complex Hospitalari Universitari Moisès Broggi

Sant Joan Despí, Barcelona, Spain, 08970

Actively Recruiting

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Research Team

G

Giosafat Spitaleri, M.D.

R

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

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Frequently Asked Questions

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