Evaluating Residual Congestion at Discharge in Acute Heart Failure Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorConsorci Sanitari Integral
About this trial
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
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years.
Symptoms classified as New York Heart Association class III or IV.
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).
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).
Disqualifiers
Known diagnosis of septicemia.
Glomerular filtration rate < 15 ml/min.
Life expectancy < 6 months.
Active myocarditis.
Trial population
Patients hospitalized for acute heart failure
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Evaluation of residual congestion at discharge
Diagnostic testEvaluation 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.
Treatment groups
500 Participants
are divided into 1 treatment groupGroup A: Patients hospitalized for acute heart failure1 intervention
Trial outcomes
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 dischargeSecondary outcomes
1
all-cause death
Time frame
6 months after hospital discharge2
time to first heart failure event
Time frame
6 months after hospital discharge3
number of heart failure events
Time frame
6 months after hospital dischargeSponsors and contacts
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Source ClinicalTrials.gov