Evaluating residual congestion in patients with acute heart failure at discharge
Multiparametric Assessment of Residual Congestion at Discharge in Patients With Acute Heart Failure
This study is testing new ways to check for leftover fluid in patients with acute heart failure when they leave the hospital to see if it can help predict their recovery better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Consorci Sanitari Integral Academic / other |
| Locations | 1 site (Sant Joan Despí, Barcelona) |
| Trial ID | NCT06993220 on ClinicalTrials.gov |
What this trial studies
This study focuses on assessing residual congestion in patients who have been hospitalized for acute heart failure. It employs a multiparametric approach to evaluate various indicators of congestion at the time of discharge, aiming to identify the most effective prognostic strategies. The study also incorporates artificial intelligence to develop a prognostic algorithm that enhances predictive accuracy compared to traditional methods. By comparing different evaluation techniques, the study seeks to improve risk stratification for patients with acute heart failure.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are hospitalized for new onset or worsening heart failure with specific clinical signs of volume overload.
Not a fit: Patients with severe comorbidities, such as septicemia or advanced liver disease, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better management of acute heart failure patients, reducing the risk of poor outcomes associated with residual congestion.
How similar studies have performed: While the association between residual congestion and outcomes has been established, this multiparametric approach with AI support is relatively novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Sant Joan Despí, Barcelona
- Complex Hospitalari Universitari Moisès Broggi — Sant Joan Despí, Barcelona, Spain (Recruiting)
Study contacts
- Principal investigator: Giosafat Spitaleri, M.D. — Consorci Sanitari Integral
- Study coordinator: Giosafat Spitaleri, M.D.
- Email: gspitaleri@csi.cat
- Phone: +34 654471303
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.