title: Genetic and ElectroNic medIcal records to predict oUtcomeS in Heart Failure patients (GENIUS-HF) - design and rationale.
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
  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.
  
  
  CONCLUSIONS
  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).
  
  
  BACKGROUND
  Current Controlled Trials NTC02043431.
authors.forename: Luciana
authors.initials: L
authors.lastname: Gioli-Pereira
authors.forename: Sabrina
authors.initials: S
authors.lastname: Bernardez-Pereira
authors.forename: Fabiana
authors.initials: F
authors.lastname: Goulart Marcondes-Braga
authors.forename: Joceli Mabel
authors.initials: JM
authors.lastname: Rocha Spina
authors.forename: Rafael
authors.initials: R
authors.lastname: Muniz Miranda da Silva
authors.forename: Noely
authors.initials: N
authors.lastname: Evangelista Ferreira
authors.forename: Fernando
authors.initials: F
authors.lastname: Bacal
authors.forename: Fábio
authors.initials: F
authors.lastname: Fernandes
authors.forename: Alfredo José
authors.initials: AJ
authors.lastname: Mansur
authors.forename: José Eduardo
authors.initials: JE
authors.lastname: Krieger
authors.affiliation: Laboratory of Genetics and Molecular Cardiology, Heart Institute (InCor) of University of São Paulo Medical School, Avenue Dr, Enéas de Carvalho Aguiar, 44 Cerqueira César, São Paulo, SP 05403-000, Brazil. alexandre.pereira@incor.usp.br.
authors.forename: Alexandre
authors.initials: A
authors.lastname: Costa Pereira
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000465:Algorithms; D001938:Brazil; D019091:Critical Pathways; D057286:Electronic Health Records; D020022:Genetic Predisposition to Disease; D055106:Genome-Wide Association Study; D006333:Heart Failure / Q000175:diagnosis / Q000235:genetics* / Q000401:mortality / Q000503:physiopathology / Q000628:therapy; D006801:Humans; D008875:Middle Aged; D010641:Phenotype; D011237:Predictive Value of Tests; D011379:Prognosis; D012107:Research Design; D012307:Risk Factors; D013318:Stroke Volume; D062606:Tertiary Care Centers; D013997:Time Factors; D014015:Tissue Banks; D016277:Ventricular Function, Left; D055815:Young Adult