Electronic Medical Records and Genomics

University of Sao Paulo General Hospital

Status: Unknown

Conditions: Heart Failure

Study type: Observational

Funder types: Other

Identifiers

NCT02043431

EMR-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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