Next-generation, Integrative, and Personalized Risk Assessment to Prevent Recurrent Heart Failure Events: the ORACLE Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,134
- 试验地点
- 1
- 主要终点
- To compare the model performance of the comprehensive risk assessment algorithm with a traditional risk model to predict HF related hospitalizations or all-cause death
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
To compare the model performance of the comprehensive risk assessment algorithm with a traditional risk model to predict HF related hospitalizations or all-cause death
时间窗: 6 months
To compare in an external validation cohort of patients a recent acute HF event, the performance (discrimination, additive predictive value, and reclassification ability) of a comprehensive risk assessment algorithm with the performance of a traditional risk model to predict the occurrence of the primary composite clinical end-point of HF related hospitalizations (readmissions) or all-cause death at 180 days after hospital discharge or after an urgent HF visit (acute HF event requiring intravenous administration of diuretics without admission).
次要结局
- To compare the model performance of the comprehensive risk assessment algorithm with a traditional risk model to predict the occurrence of HF-related hospitalizations (readmissions) or all-cause death at 30, and 90 days after hospital discharge.(6 months)
- To compare the model performance of the comprehensive risk assessment algorithm with a traditional risk model to predict the occurrence of HF-related hospitalizations (readmissions) at 30, 90, and 180 days after hospital discharge.(6 months)
- To compare the model performance of the comprehensive risk assessment algorithm with a traditional risk model to predict the occurrence of all-cause death at 30, 90, and 180 days, after hospital discharge.(6 months)
研究者
Josep Comín
Prof. Josep Comín-Colet, MD, PhD
Hospital Universitari de Bellvitge