Arrhythmic Risk Stratification in Nonischemic Dilated Cardiomyopathy

Summary

Nonischemic dilated cardiomyopathy is a heterogeneous disease often associated with increased rates of sudden cardiac death. Although many algorithms have been proposed, risk stratification remains suboptimal, and implantable cardioverter-defibrillators are currently recommended only in patients with poor left ventricular function. However, most cases of sudden cardiac death occur at earlier stages, in patients with relatively preserved left ventricular function and exercise capacity, for which device-therapy is currently not indicated. Several noninvasive risk factors have been associated with increased arrhythmic risk, including clinical history (syncope), imaging (fibrosis on cardiac magnetic resonance imaging and left ventricular dimensions in echocardiography) and electrocardiographic parameters (ventricular arrhythmic burden, late potentials, heart rate variability and repolarization abnormalities).

The investigators hypothesized that the encouraging findings of studies assessing more sophisticated stratification-algorithms in patients with ischemic heart disease could be extrapolated in patients with nonischemic dilated cardiomyopathy. Thus, combining noninvasive risk factors with programmed ventricular stimulation may risk-stratify such patients more accurately. In this regard, the prospective observational multicenter ReCONSIDER study aims to integrate several approaches to arrhythmic risk stratification in nonischemic dilated cardiomyopathy in a tiered, multifactorial, approach, in which noninvasive risk factors are combined with electrophysiologic studies. This approach may pave the way for a more comprehensive risk stratification algorithm in patients with nonischemic dilated cardiomyopathy, leading to more rational device-therapy, and, ultimately to lower mortality.

Conditions

• Sudden Cardiac Death Due to Cardiac Arrhythmia
• Dilated Cardiomyopathy

Interventions

DEVICE

Implantable Cardioverter Defibrillator (ICD) insertion

Implantation of ICD when arrhythmic risk is deemed high in those with LVEF between 35%-50%, and to all with LVEF\<35%. Aim to determine whether risk stratification accuracy can be improved more than that of the current approach regarding primary prevention of sudden cardiac arrhythmic death in nonischemic dilated cardiomyopathy patients (no ICDs to those with LVEF between 35%-50% and ICDs to all with LVEF \<35%. In patients in the LVEF \<35% groups, ICDs will be used as implantable recorders, to determine whether occurrence of major arrhythmic events (MAEs) can be better predicted by NIRFs/PVS than by LVEF alone.

Sponsors & Collaborators

• University of Athens

  lead OTHER

Principal Investigators

• Konstantinos A Gatzoulis, MD · Hippokrateion General Hospital of Athens

Study Design

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-09-01

Primary Completion

2025-05-01

Completion

2025-05-01

FDA Device

Yes

Countries

• Greece

Study Locations