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临床试验/NCT02043431
NCT02043431Unknown不适用

Genetic and Electronic Medical Records to Predict Outcomes in Heart Failure Patients

University of Sao Paulo General Hospital1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2012年8月最近更新:
适应症

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

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.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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