Arrhythmia Prediction Trial

• Conditions: Dilated Cardiomyopathy; Myocardial Infarction; Heart Failure

• Registration Number: NCT02175836
• Lead Sponsor: University of Athens

Brief Summary

Patients with Ischaemic and Dilated Cardiomyopathy, face an increased risk for Arrhythmic Sudden Cardiac Death. The purpose of this study is to estimate the performance of Modern Non-Invasive Indices and the performance of Programmed Ventricular Stimulation in Sudden Cardiac Death Prediction.

Detailed Description

Sudden Cardiac Death (SCD) threatens survival of Coronary Artery Disease and Dilated Cardiomyopathy patients with Heart Failure. Discovering efficient SCD risk stratification markers is of high importance. In this study, heart failure patients will be risk stratified with indices from the Myocardial substrate (QRS, fragmented QRS, Late potentials, LVEF), indices from the Repolarization status (QT duration, QT rate corrected , QT dispersion, QT/RR, T wave Amplitude Variability, T wave alternans, QT Variability Index), indices from the Autonomic Nervous System function \[ Heart Rate variability, Heart rate Turbulence, Deceleration Capacity (DC) , DC sign of fraction, Beat to Beat DC, Non linear indices of Heart Rate Dynamics\], the Non sustained ventricular tachycardia and Ventricular extrasystolic activity and the Circadian Properties of Heart Rate observed during Ambulatory Monitoring. Furthermore Programmed Ventricular Stimulation will be used. High resolution 30 min ECG recordings will performed for further indices research and development. All the Arrhythmic Risk Stratifiers will be analysed and their performance for Sudden Cardiac Death Prediction and for Total Mortality will be estimated according the follow up.

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2014-06-24
• Study First Submitted QC: 2014-06-25
• Study First Posted: 2014-06-26
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-27
• Last Update Posted: 2016-01-28
• Primary Completion: 2019-06
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Myocardial Infarction
• Dilated Cardiomyopathy
• Sinus rhythm

Exclusion Criteria

• Malignant diseases seriously affecting the survival
• Conditions/diseases affecting the Autonomic Nervous System's function
• Dementia
• Alcoholism
• Psychiatric diseases
• Addiction

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sudden Cardiac Death surrogates: 1.Clinical Ventricular Tachyarrhythmia, 2.ICD's appropriate activation, 3.Confirmed Sudden Cardiac Death	2007-2019 (12 years)

Secondary Outcome Measures

Name	Time	Method
Total Mortality	2007-2019 (12 years)

Trial Locations

Locations (1)

First Department of Cardiology, Medical School, National & Kapodistrian University of Athens; 🇬🇷 Athens, Greece