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NCT05679713
Next-generation, Integrative, and Personalized Risk Assessment to Prevent Recurrent Heart Failure Events: the ORACLE Study
Conditions: Heart Failure
Sex: All
Ages: 18 Years – N/A
Enrollment: 1134
Sponsor: Hospital Universitari de Bellvitge
Location: Spain
Summary
The aim of this study is to develop and validate an improved, comprehensive risk assessment algorithm integrating blood RNA-based biomarkers, clinical, and patient-centered data and to assess the incremental predictive value (discrimination and reclassification) compared to a traditional risk model (change in the c-statistics for prediction of the primary endpoint).
Eligibility Criteria
Inclusion Criteria:Age ≥ 18 years old.Patients with a recent (<30 days) acute decompensation of HF requiring intravenous diuretic therapy (either hospitalized or in ambulatory care) or intensification of oral diuretics (ambulatory care).HF diagnosis according to European Society of Cardiology (ESC) criteria.Written informed consentPatients receiving oral standard medication for chronic HF.Exclusion Criteria:Age<18 years old.Death before hospital discharge.The patient is unable or unwilling to give the informed consent to participate.Unstable patients with signs of fluid overload or low cardiac output at the moment of enrollment.
Source: ClinicalTrials.gov (NCT05679713). StuddyBuddy aggregates publicly available trial information.