We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Electronic Medical Records and Genomics

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02043431
First Posted: January 23, 2014
Last Update Posted: December 16, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ministry of Health, Brazil
Information provided by (Responsible Party):
University of Sao Paulo General Hospital
  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: 2 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 ]

Secondary Outcome Measures:
  • cardiovascular mortality [ Time Frame: six month ]

Other Outcome Measures:
  • Hospitalization for worsening heart failure [ Time Frame: six month ]

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

Enrollment: 700
Study Start Date: August 2012
Estimated Study Completion Date: December 2016
Primary Completion Date: July 2015 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
  Contacts and Locations
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


Locations
Brazil
Heart Institute - Clinical Hospital - University of São Paulo Medical School
Sao Paulo, Brazil, 050403000
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

Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02043431     History of Changes
Other Study ID Numbers: EMR-01
First Submitted: January 20, 2014
First Posted: January 23, 2014
Last Update Posted: December 16, 2015
Last Verified: December 2015

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