Electronic Medical Records and Genomics

• Conditions: Heart Failure

• Registration Number: NCT02043431
• Lead Sponsor: University of Sao Paulo General Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2014-01-20
• Study First Submitted QC: 2014-01-20
• Study First Posted: 2014-01-23
• Status Verified: 2018-01
• Last Update Submitted: 2018-02-21
• Last Update Posted: 2018-02-23
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Age between 18 and 80 years old
• Heart failure diagnosis of different etiologies
• Left ventricular ejection fraction < 50% in the past 2 years

Exclusion Criteria

• Patients with impaired cognition due to advanced dementia syndrome or severe psychiatric disorder
• Patients without telephone access
• Patients that refused to participate

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
all cause mortality	six and twelve months after inclusion.	Deaths for all causes after 6 months of inclusion. Deaths for all causes after 12 months of inclusion

Secondary Outcome Measures

Name	Time	Method
cardiovascular mortality	six and twelve months after inclusion.	Deaths for cardiovascular cause after 6 months of inclusion. Deaths for cardiovascular cause after 12 months of inclusion.

Trial Locations

Locations (1)

Heart Institute - Clinical Hospital - University of São Paulo Medical School; 🇧🇷 Sao Paulo, Brazil