Electronic Medical Records and Genomics

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of Sao Paulo General Hospital
Sponsor:
Collaborator:
Ministry of Health, Brazil
Information provided by (Responsible Party):
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT02043431
First received: January 20, 2014
Last updated: NA
Last verified: January 2014
History: No changes posted
  Purpose

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
Heart Failure

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Genetic and Electronic Medical Records to Predict Outcomes in Heart Failure Patients

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • all cause mortality [ Time Frame: six month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • cardiovascular mortality [ Time Frame: six month ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Hospitalization for worsening heart failure [ Time Frame: six month ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Whole blood, urine.


Estimated Enrollment: 2000
Study Start Date: August 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02043431     History of Changes
Other Study ID Numbers: EMR-01
Study First Received: January 20, 2014
Last Updated: January 20, 2014
Health Authority: Brazil: Ministry of Health

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

ClinicalTrials.gov processed this record on October 02, 2014