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Clinical Trials/NCT02043431
NCT02043431
Unknown
Not Applicable

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

University of Sao Paulo General Hospital1 site in 1 country1,000 target enrollmentAugust 2012
ConditionsHeart Failure

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure
Sponsor
University of Sao Paulo General Hospital
Enrollment
1000
Locations
1
Primary Endpoint
all cause mortality
Last Updated
8 years ago

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.

Registry
clinicaltrials.gov
Start Date
August 2012
End Date
December 2018
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.)

Study Sites (1)

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