Genetic Risk Assessment of Defibrillator Events

Completed

• Conditions: Congestive Heart Failure; Cardiomyopathy; Sudden Cardiac Death; Arrhythmias

• Registration Number: NCT02045043
• Lead Sponsor: University of Iowa

Brief Summary

Arrhythmias remain a major health problem, causing at least 250,000 deaths annually in the United States. Pharmacological treatments often do more harm than good, and device therapies are limited by high cost and effects on quality of life. Ion channel mutations cause rare inherited arrhythmopathies, but account for only a small fraction of patients with life- threatening arrhythmias and sudden death. Most arrhythmias occur during myocardial ischemia, following myocardial infarction, and in patients with poor left ventricular (LV) function of any etiology. Aside from ejection fraction (EF), few clinically useful indicators to stratify the risk of sudden death have been identified. The role of subtle difference in ion channel expression and/or structure in predisposing patients to arrhythmias and modulating the risk of sudden death is unknown.

In this study, we are prospectively testing whether polymorphisms in ion channels and ion channel modifying genes are associated with arrhythmias in a population with internal cardioverter-defibrillators (ICDs) and poor LV function. We will test the hypothesis that functional polymorphisms in the coding sequences and promoter regions of cardiac genes (e.g. ion channels, beta-adrenergic receptors) predispose individuals to arrhythmias and /or heart failure progression.

We hope to identify genetic predictors for the common forms of sudden cardiac death. This would allow the identification of a subpopulation of heart failure patients that would benefit most from ICD placement.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-03
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2014-01
• Study First Submitted: 2014-01-22
• Study First Submitted QC: 2014-01-22
• Last Update Submitted: 2014-01-22
• Study First Posted: 2014-01-24
• Last Update Posted: 2014-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1807

Inclusion Criteria

• An ICD placed during the last 5 years, or a planned ICD within 1 month
• Age 18 or older
• Left Ventricular Ejection fraction < or = 30%
• Ability to give informed consent

Exclusion Criteria

• Patient refuses or is unable to give consent
• A life expectancy <6 months from a non-cardiac life threatening disease
• Ongoing Class IV heart failure symptoms despite treatment
• History of cardiac transplant or left ventricular assist device

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Shock-Free Survival	Up to 5 years	Time to first appropriate shock from an Implantable Cardioverter-Defibrillator

Secondary Outcome Measures

Name	Time	Method
Appropriate Shock Frequency	Up to 5 years	The number of appropriate shocks per year
Survival	Up to 5 years	Time to death from any cause
Transplant- and VAD-Free Survival	Up to 5 years	Time to occurence of death from any cause, cardiac transplantation, or Ventricular Assist Device placement (whichever comes first)

Trial Locations

Locations (6)

Mid Ohio Cardiology; 🇺🇸 Columbus, Ohio, United States

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

Massuchetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

VA Pittsburgh Healthcare System; 🇺🇸 Pittsburgh, Pennsylvania, United States

The Ohio State University; 🇺🇸 Columbus, Ohio, United States