Genetic and Electronic Medical Records to Predict Outcomes in Heart Failure Patients
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 1,000
- Locations
- 1
- Primary Endpoint
- all cause mortality
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
all cause mortality
Time Frame: 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 Outcomes
- cardiovascular mortality(six and twelve months after inclusion.)