Electronic Medical Records and Genomics

February 21, 2018 updated by: University of Sao Paulo General Hospital

Genetic and Electronic Medical Records to Predict Outcomes in Heart Failure Patients

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.

Study Overview

Status

Unknown

Conditions

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

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Luciana Gioli-Pereira, MD, PhD
  • Phone Number: 55-11-2661-5081
  • Email: lu_gioli@yahoo.com

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 050403000
        • Recruiting
        • Heart Institute - Clinical Hospital - University of São Paulo Medical School
        • Contact:
        • Sub-Investigator:
          • Luciana Gioli-Pereira, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The elegible individuals are patients of a tertiary cardiology hospital

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
six and twelve months after inclusion.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
six and twelve months after inclusion.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospitalization for any cause
Time Frame: six and twelve months after inclusion.
necessity of hospital care in 6 and 12 months of follow-up
six and twelve months after inclusion.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Collaborators

Ministry of Health, Brazil

Investigators

  • Principal Investigator: Alexandre C Pereira, MD, PhD, Heart Institute - Clinical Hospital - University of São Paulo Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

January 20, 2014

First Submitted That Met QC Criteria

January 20, 2014

First Posted (Estimate)

January 23, 2014

Study Record Updates

Last Update Posted (Actual)

February 23, 2018

Last Update Submitted That Met QC Criteria

February 21, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMR-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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