Electronic Medical Records and Genomics
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.
|Study Type:||Observational [Patient Registry]|
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration:||3 Years|
|Official Title:||Genetic and Electronic Medical Records to Predict Outcomes in Heart Failure Patients|
- all cause mortality [ Time Frame: six month ] [ Designated as safety issue: No ]
- cardiovascular mortality [ Time Frame: six month ] [ Designated as safety issue: No ]
- Hospitalization for worsening heart failure [ Time Frame: six month ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Whole blood, urine.
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02043431
|Contact: Alexandre C Pereira, MD, PhDemail@example.com|
|Contact: Luciana Gioli-Pereira, MD, PhDfirstname.lastname@example.org|
|Heart Institute - Clinical Hospital - University of São Paulo Medical School||Recruiting|
|Sao Paulo, Brazil, 050403000|
|Contact: Luciana Gioli-Pereira, MD, PhD 55-11-2661-5081 email@example.com|
|Sub-Investigator: Luciana Gioli-Pereira, MD, PhD|
|Principal Investigator:||Alexandre C Pereira, MD, PhD||Heart Institute - Clinical Hospital - University of São Paulo Medical School|