This trial is active, not recruiting.

Condition heart failure
Sponsor University of Sao Paulo General Hospital
Collaborator Ministry of Health, Brazil
Start date August 2012
End date July 2015
Trial size 700 participants
Trial identifier NCT02043431, EMR-01


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

all cause mortality
time frame: six month

Secondary Outcomes

cardiovascular mortality
time frame: six month

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title Genetic and Electronic Medical Records to Predict Outcomes in Heart Failure Patients
Principal investigator Alexandre C Pereira, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by University of Sao Paulo General Hospital.