Overview

This trial is active, not recruiting.

Conditions cardiomyopathy, ventricular tachycardia, ventricular fibrillation
Sponsor Ochsner Health System
Collaborator Boston Scientific Corporation
Start date June 2012
End date October 2016
Trial size 220 participants
Trial identifier NCT01892462, ISRCRM400003

Summary

The purpose of this study is to determine whether levels of inflammatory markers in circulating blood can correlate with risk for dangerous heart rhythms. Patients with systolic heart failure, which has been shown to increase risk for dangerous heart rhythms, will be enrolled. All subjects will have an implantable cardioverter-defibrillator (ICD) in place, which allows regular evaluation of heart rhythm.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
to evaluate a large population of heart failure patients with regard to circulating biomarkers and rates of subsequent ventricular arrhythmias.
time frame: 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - left ventricular ejection fraction [LVEF] <=35% - ICD implant Exclusion Criteria: - Recent myocardial infarction (12 weeks) - Recent revascularization (12 weeks) - Recent hospitalization for any cause (6 weeks) - History of rheumatologic disease

Additional Information

Official title Circulating Biomarkers and Ventricular Tachyarrhythmia
Principal investigator Daniel P Morin, MD MPH
Description If you agree to be in this study, you will be asked to the following things: - you will come into the EP device clinic every three months for one year to have your device interrogated and will complete an EKG - you will have labs drawn to measure levels of certain markers of inflammation in the body. This information will be used to identify new ways to test for risk of abnormal heart rhythms and other heart disease - you will review your medications with the study coordinator and along with any recent illnesses or hospitalizations
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Ochsner Health System.