Genetic and Electronic Medical Records to Predict Outcomes in Heart Failure Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- all cause mortality
研究概览
简要总结
The purpose of this study is to develop a biobank containing samples of 2,000 patients treated in a tertiary cardiology hospital containing electronic medical records and genetic data in genome-wide scale for performing genetic association studies for validation and development of medical decision routines that help the clinical management of heart failure patients.
详细描述
Patients between 18 and 80 years old with heart failure diagnosis of different etiologies and left ventricular ejection fraction < 50% in the past 2 years will be eligible for enrollment on the cohort. After consent, patients will be submitted to clinical baseline, echocardiographic, cardiography impedance and biochemical evaluation. Study data will be collected and managed using Research Electronic Data Capture (REDCap) tools. The follow up will take place every 6 months to assess cardiovascular outcomes (all-cause mortality, cardiovascular mortality, hospitalization for worsening heart failure and current medication use). Initial analytical strategy will focus on the establishment of the accuracy of electronic medical records extraction protocols for main predictor factors of morbidity and mortality in heart failure.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 80 years old
- •Heart failure diagnosis of different etiologies
- •Left ventricular ejection fraction < 50% in the past 2 years
排除标准
- •Patients with impaired cognition due to advanced dementia syndrome or severe psychiatric disorder
- •Patients without telephone access
- •Patients that refused to participate
结局指标
主要结局
all cause mortality
时间窗: six and twelve months after inclusion.
Deaths for all causes after 6 months of inclusion. Deaths for all causes after 12 months of inclusion
次要结局
- cardiovascular mortality(six and twelve months after inclusion.)
