Next-generation, Integrative, and Personalized Risk Assessment to Prevent Recurrent Heart Failure Events: the ORACLE Study

Catalan Institute of Health

Status: Enrolling

Conditions: Heart Failure

Treatments: Diagnostic Test: Comprehensive risk assessment algorithm

Study type: Observational

Funder types: Other

Identifiers

NCT05679713

PI21/00264

Details and patient eligibility

About

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).

Full description

The ORACLE study is a multicenter, observational, prospective, cross-sectional and longitudinal study integrated by 3 different cohorts for 1) RNA biomarker discovery (60 nested case-control sample), 2) model derivation (516 nested case-control sample) and 3) external validation (new prospective cohort of 558 consecutive patients recruited in 4 hospital centers) according to a TRIPOD Statement type 3 analysis. In total 1134 consecutive patients with a HF hospitalization or urgent HF visit < 30 days before inclusion and followed for 6 months will be studied.

This study include the discovery of novel RNA-based biomarkers using next-generation sequencing technology to define and validate a new biomarker set and clinical and patient-centered risk determinants definition. A new model will be constructed; training and internal validation in the derivation cohort using machine learning methods, and finally an external validation of the new next generation integrative risk assessment model will be performed.

Enrollment: 1,134 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 consent
• Patients 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.