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Electronic Medical Records and Genomics

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ClinicalTrials.gov Identifier: NCT02043431
Recruitment Status : Recruiting
First Posted : January 23, 2014
Last Update Posted : February 23, 2018
Sponsor:
Collaborator:
Ministry of Health, Brazil
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

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.

Condition or disease
Heart Failure

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.

Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Genetic and Electronic Medical Records to Predict Outcomes in Heart Failure Patients
Study Start Date : August 2012
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. cardiovascular mortality [ Time Frame: 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 Outcome Measures:
  1. Hospitalization for any cause [ Time Frame: six and twelve months after inclusion. ]
    necessity of hospital care in 6 and 12 months of follow-up


Biospecimen Retention:   Samples With DNA
Whole blood, urine. Exhaled acethone.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The elegible individuals are patients of a tertiary cardiology hospital
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02043431


Contacts
Contact: Alexandre C Pereira, MD, PhD 55-11-2661-5543 alexandre.pereira@incor.usp.br
Contact: Luciana Gioli-Pereira, MD, PhD 55-11-2661-5081 lu_gioli@yahoo.com

Locations
Brazil
Heart Institute - Clinical Hospital - University of São Paulo Medical School Recruiting
Sao Paulo, Brazil, 050403000
Contact: Luciana Gioli-Pereira, MD, PhD    55-11-2661-5081    lu_gioli@yahoo.com   
Sub-Investigator: Luciana Gioli-Pereira, MD, PhD         
Sponsors and Collaborators
University of Sao Paulo General Hospital
Ministry of Health, Brazil
Investigators
Principal Investigator: Alexandre C Pereira, MD, PhD Heart Institute - Clinical Hospital - University of São Paulo Medical School

Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02043431     History of Changes
Other Study ID Numbers: EMR-01
First Posted: January 23, 2014    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: January 2018

Keywords provided by University of Sao Paulo General Hospital:
Heart failure
Electronic medical records
Genomics
Biobank

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases