Arrhythmia Prediction Trial and Risk Stratification in Heart Failure Patients - Athens.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Myocardial Infarction
- Sponsor
- University of Athens
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Sudden Cardiac Death surrogates: 1.Clinical Ventricular Tachyarrhythmia, 2.ICD's appropriate activation, 3.Confirmed Sudden Cardiac Death
- Last Updated
- 10 years ago
Overview
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.
Investigators
PETROS ARSENOS
MD, PhD
University of Athens
Eligibility Criteria
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
- •Alcoholism
- •Psychiatric diseases
- •Addiction
Outcomes
Primary Outcomes
Sudden Cardiac Death surrogates: 1.Clinical Ventricular Tachyarrhythmia, 2.ICD's appropriate activation, 3.Confirmed Sudden Cardiac Death
Time Frame: 2007-2019 (12 years)
Secondary Outcomes
- Total Mortality(2007-2019 (12 years))