Ventricular Tachyarrhythmia (VT) Storm, Gene Expression in Implantable Cardioverter Defibrillator (ICD) Patients With Electrical Storm

Completed

• Conditions: Arrhythmias
• Interventions: Procedure: Peripheral blood sampling

• Registration Number: NCT00284453
• Lead Sponsor: University of Pittsburgh

Brief Summary

The purpose of the proposed pilot study is to identify factors which are associated with periods of high ventricular arrhythmia burden. This will be performed by analysis of gene expression from peripheral blood samples.

Detailed Description

This is a study of patients with ICD implants who present with multiple(\>2), low-level(1-2) or inappropriate therapies to their defibrillator. The purpose of this pilot study is to identify factors which are associated with periods of high ventricular arrhythmia burden by looking at gene expression from peripheral blood, in addition to levels of known markers of CHF, including catecholamine levels, B-type natriuretic peptide, and troponin. This study hypothesizes that extrinsic or systemic factors play a role in triggering these events, and if true should yield candidate proteins which would spawn functional studies to prove a role in causation. Additionally, identification of a marker of increased recurrence of events may aid in guiding therapy (starting an anti-arrhythmic versus awaiting the next event).

Study Timeline

• Study First Submitted: 2006-01-27
• Study First Submitted QC: 2006-01-27
• Study First Posted: 2006-01-31
• Study Start: 2008-08-26
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-08
• Last Update Posted: 2019-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

• ICD patients at least 18 years of age that present within a 72 hour period: 1) > 2 therapies for ventricular arrhythmias; 2) 1-2 therapies for ventricular arrhythmias; 3) inappropriate therapies for ventricular arrhythmias
• Able to give informed consent

Exclusion Criteria

• Inability to give informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Peripheral blood sampling	Forty(40)subjects that have received \>2 appropriate ICD shock therapies
2	Peripheral blood sampling	Twenty(20)subjects that have received 1-2(low level)appropriate ICD therapies
3	Peripheral blood sampling	Ten(10)subjects that received inappropriate therapies from their ICD

Primary Outcome Measures

Name	Time	Method
Genetic Testing	Day 90 +/- 30 days	Identification of factors which are associated with periods of high ventricular arrhythmia burden (Day 1) by looking at gene expression from peripheral blood, in addition to levels of known markers of congestive heart failure (catecholamine levels, B-type natriuretic peptide, and troponin)in comparison to subject's return to own normal state (3 month +/- 30 days)

Trial Locations

Locations (2)

UPMC Presbyterian Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States

UPMC Shadyside Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States