Electronic Medical Records and Genomics

NCT ID: NCT02043431

Last Updated: 2018-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-08-31

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, Brazil

OTHER_GOV

Sponsor Role collaborator

University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexandre C Pereira, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Heart Institute - Clinical Hospital - University of São Paulo Medical School

Locations

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Heart Institute - Clinical Hospital - University of São Paulo Medical School

São Paulo, , Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Alexandre C Pereira, MD, PhD

Role: CONTACT

55-11-2661-5543

Luciana Gioli-Pereira, MD, PhD

Role: CONTACT

55-11-2661-5081

Facility Contacts

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Luciana Gioli-Pereira, MD, PhD

Role: primary

55-11-2661-5081

Other Identifiers

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EMR-01

Identifier Type: -

Identifier Source: org_study_id

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