Clinical trial NCT02175836: Arrhythmia Prediction Trial
Official title: Arrhythmia Prediction Trial and Risk Stratification in Heart Failure Patients - Athens.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myocardial Infarction
Dilated Cardiomyopathy
Heart Failure
Keywords: Arrhythmic Sudden Cardiac Death
Heart Failure
Risk Stratification
Autonomic Nervous System
Heart Rate
Repolarization
Lead sponsor: University of Athens
Sponsor class: OTHER
First posted: 2014-06-26
Enrollment: 500
Sex: ALL
Minimum age (years): 20
Maximum age (years): 82
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Heart Failure Patients with Myoacardial Infarction and Dilated Cardiomyopathy maintaining sinus rhyhtm.

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.

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
* Dementia
* Alcoholism
* Psychiatric diseases
* Addiction

Primary outcomes:
measure: Sudden Cardiac Death surrogates: 1.Clinical Ventricular Tachyarrhythmia, 2.ICD's appropriate activation, 3.Confirmed Sudden Cardiac Death
timeFrame: 2007-2019 (12 years)
Secondary outcomes:
measure: Total Mortality
timeFrame: 2007-2019 (12 years)
Other outcomes:
Locations:
city: Athens
country: Greece
facility: First Department of Cardiology, Medical School, National & Kapodistrian University of Athens
Study officials:
affiliation: First Department of Cardiology, Medical School, National & Kapodistrian University of Athens, Greece
name: Petros Arsenos, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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