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01.12.2014 | Study protocol | Ausgabe 1/2014 Open Access

BMC Cardiovascular Disorders 1/2014

Genetic and ElectroNic medIcal records to predict oUtcomeS in Heart Failure patients (GENIUS-HF) - design and rationale

Zeitschrift:
BMC Cardiovascular Disorders > Ausgabe 1/2014
Autoren:
Luciana Gioli-Pereira, Sabrina Bernardez-Pereira, Fabiana Goulart Marcondes-Braga, Joceli Mabel Rocha Spina, Rafael Muniz Miranda da Silva, Noely Evangelista Ferreira, Fernando Bacal, Fábio Fernandes, Alfredo José Mansur, José Eduardo Krieger, Alexandre Costa Pereira
Wichtige Hinweise

Competing interests

The authors declare that they have no potential conflicts of interest regarding the present publication.

Authors’ contributions

LGP performed the acquisition of data, drafted the manuscript. SBP performed the acquisition of data, helped to draft the manuscript. FGMB performed the acquisition of data, helped to draft the manuscript. JMRS performed the collection of data, carried out part of the molecular genetic studies. RMMS performed the collection of data. NEF carried out part of the molecular genetic studies. FB helped in the patients recruitment. FF helped in the patients recruitment. AJM participated in study design and helped in the patients recruitment. JEK conceived the study, and participated in its design. ACP conceived of the study, and participated in its design and coordination and helped to draft the manuscript. All authors read and approved the final manuscript.

Abstract

Background

Studies adopting electronic medical records and genomic information are becoming widespread. Through this new modality in research, it is possible to study how genetic variants influence susceptibility towards chronic conditions and can improve patient care.
Our aim is to develop a biobank with 2,000 heart failure patients treated in a tertiary cardiology hospital containing electronic medical records data and biologic samples for performing genome-wide association studies for validation and development of medical decision routines aimed at helping the clinical management of patients.

Methods/Design

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, echocardiography, cardiograph impedance and biochemical evaluation. Study data will be collected and managed using Research Electronic Data Capture 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.

Discussion

Building a biobank with biologic samples and clinical data of 2,000 heart failure patients we will perform genome-wide association studies. By this way, we pretend to study how genetic variants influence susceptibility towards chronic conditions. Besides, it will be created a working group focused on the development and implementation of algorithms for validation and application of medical routines using the electronic medical records of the Heart Institute (InCor - HCFMUSP).

Trial registration

Current Controlled Trials NTC02043431.
Literatur
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