Electronic Medical Records and Genomics

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02043431

Enrollment

1000

Registered

2014-01-23

Start date

2012-08-31

Completion date

2018-12-31

Last updated

2018-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

Heart failure, Electronic medical records, Genomics, Biobank

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Other

Measure	Time frame	Description
Hospitalization for any cause	six and twelve months after inclusion.	necessity of hospital care in 6 and 12 months of follow-up

Countries

Brazil

Contacts

Primary ContactAlexandre C Pereira, MD, PhD

alexandre.pereira@incor.usp.br55-11-2661-5543

Backup ContactLuciana Gioli-Pereira, MD, PhD

lu_gioli@yahoo.com55-11-2661-5081

Outcome results