Arrhythmia Prediction Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Arrhythmia Prediction Trial and Risk Stratification in Heart Failure Patients - Athens.

Conditions
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Myocardial Infarction, Dilated Cardiomyopathy, Heart Failure

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 82 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SCD possitive versus SCD negative group<br>The total Heart Failure patients subgroup experiencing Sudden Cardiac Death surrogate end-points during follow up versus the patients subgroup that is free from Sudden Cardiac Death surrogate end-points. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Mortality |  | 2007-2019 (12 years) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arrhythmic Sudden Cardiac Death, Heart Failure, Risk Stratification, Autonomic Nervous System, Heart Rate, Repolarization