Sodium Channel Splicing in Heart Failure Trial

Completed

Conditions studied: Atrial Fibrillation, Atrial Flutter, Heart Failure

In brief

The purpose of this research is to see if investigators can detect truncated mRNA splice variants of the cardiac voltage-gated sodium (Na+) channel gene, SCN5A, in patients with a weak heart (Heart Failure) with or without an implantable cardioverter-defibrillator (ICD) and compare them to patients with a normal heart. Hypothesis: 1. Patients with reduced left ventricular ejection fraction have increased abundances truncated mRNA splice variants of the SCN5A gene, which portends to sodium channel dysfunction and an increased risk for sudden cardiac death. 2. Patients with implantable cardioverter-defibrillator devices (ICDs) who have experienced shock therapy have increased abundances of truncated mRNA splice variants of the SCN5A gene compared to similar congestive heart failure patients who have not experienced shock therapy.

Key facts

Study ID

NCT01185587

Run by

University of Illinois at Chicago

People needed

147

Starts

2010-02-01

Expected to finish

2014-04-01

Last updated by the study team

2014-04-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• All patients must be greater than 18 years of age
• Patients with reduced left ventricular function (i.e., heart failure patients) must have acquired heart failure and an ejection fraction less than 35% documented in the last two years by any methodology
• Control population patients must be free of heart failure symptoms, diastolic dysfunction, and left ventricular systolic dysfunction documented by any methodology within 1 year of study enrollment
• Patients with an ICD in place for more than 1 year and evidence of ICD events
• Patients with an ICD in place for more than 1 year and no evidence of ICD events
• All patients must be able to give informed consent

You may not qualify if…

• Patients less than 18 years of age.
• History of congenital heart disease as cause of impaired left ventricular function.
• Control patients with impaired left ventricular systolic function or the presence of diastolic dysfunction.
• Control or Study group patients with a history of congenital electrophysiological disorders like the long-QT syndrome or Brugada disease will not be included.
• Control or Study group patients who require antiarrhythmic drugs other than Vaughn-Williams Class II and IV agents.
• Control patients with a history of significant illness that may otherwise impair cardiac function within 12 months of study enrollment. These conditions include: myocardial infarction, cardiac hospitalization, cardiac arrhythmia, infection, or cancer.
• ICD patients suffering from any other terminal or chronic inflammatory illness.
• Patients taking immunosuppressive medications, have chronic infection, or have an acute or chronic inflammatory illness that might alter white cell mRNA expression.
• Patients with any illness expected to result in death within 18 months of enrollment.
• Patients with white blood cell dyscrasia or cancers.
• Current illicit drug use.
• Inability to give informed consent.

Where it is running

• Jesse Brown VA Medical Center — Chicago, Illinois, United States
• University of Illinois at Chicago — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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