Electronic Medical Records and Genomics

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02043431
• Other study ID #: EMR-01
• Status: Recruiting
• Phase: N/A
• First received: January 20, 2014
• Last updated: February 21, 2018
• Start date: August 2012
• Est. completion date: December 2018

Study information

• Verified date: January 2018
• Source: University of Sao Paulo General Hospital
• Contact: Alexandre C Pereira, MD, PhD
• Phone: 55-11-2661-5543
• Email: alexandre.pereira[@]incor.usp.br
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
Brazil	Heart Institute - Clinical Hospital - University of São Paulo Medical School	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Ministry of Health, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hospitalization for any cause	necessity of hospital care in 6 and 12 months of follow-up	six and twelve months after inclusion.
Primary	all cause mortality	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	cardiovascular mortality	Deaths for cardiovascular cause after 6 months of inclusion. Deaths for cardiovascular cause after 12 months of inclusion.	six and twelve months after inclusion.