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

NCT ID: NCT05679713

Last Updated: 2023-01-11

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1134 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-09-05
• Study Completion Date: 2024-12-01

Brief 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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Interventions

Comprehensive risk assessment algorithm

Risk assessment algorithm including clinical and patient-centered information and a novel RNA-based biomarkers using next-generation sequencing technology.

Intervention Type: DIAGNOSTIC_TEST

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 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitari de Bellvitge

OTHER

Sponsor Role: lead

Responsible Party

Josep Comín

Prof. Josep Comín-Colet, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospital Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Josep Comín Colet, MD, PhD

Role: CONTACT

jcomin@bellvitgehospital.cat

+34 932607078

Raúl Ramos Polo, MD

Role: CONTACT

rramosp@bellvitgehospital.cat

+34 932607078

Facility Contacts

Josep Comín Colet, MD, PhD

Role: primary

jcomin@bellvitgehospital.cat

+34-933-35-70-11 ext. 2274

Raúl Ramos Polo, MD

Role: backup

rramosp@bellvitgehospital.cat

+34-933-35-70-11 ext. 2274

Other Identifiers

PI21/00264

Identifier Type: -

Identifier Source: org_study_id