NCT05679713

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,134 (estimated)
• Sponsor: Hospital Universitari de Bellvitge · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Comprehensive risk assessment algorithm	Risk assessment algorithm including clinical and patient-centered information and a novel RNA-based biomarkers using next-generation sequencing technology.

Timeline

• Start date: 2022-09-05
• Primary completion: 2024-09-01
• Completion: 2024-12-01
• First posted: 2023-01-11
• Last updated: 2023-01-11

Locations

1 site across 1 country: Spain