NCT06993220 Evaluating Residual Congestion at Discharge in Acute Heart Failure Patients
| NCT ID | NCT06993220 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Consorci Sanitari Integral |
| Condition | Acute Heart Failure (AHF) |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2025-01-01 with a primary completion date of 2026-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Giosafat Spitaleri, M.D.
PRINCIPAL INVESTIGATOR
Consorci Sanitari Integral
Frequently Asked Questions
Who can join the NCT06993220 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Heart Failure (AHF). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06993220 currently recruiting?
Yes, NCT06993220 is actively recruiting participants. Contact the research team at gspitaleri@csi.cat for enrollment information.
Where is the NCT06993220 trial being conducted?
This trial is being conducted at Sant Joan Despí, Spain.
Who is sponsoring the NCT06993220 clinical trial?
NCT06993220 is sponsored by Consorci Sanitari Integral. The principal investigator is Giosafat Spitaleri, M.D. at Consorci Sanitari Integral. The trial plans to enroll 500 participants.
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