Arrhythmia Prediction Trial (APRET)

National and Kapodistrian University of Athens

Status: Unknown

Conditions: Myocardial Infarction; Heart Failure; Dilated Cardiomyopathy

Study type: Observational

Funder types: Other

Identifiers

NCT02175836

17/25-10-2006

APRET, Athens Medical School (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 20 to 82 years old

Volunteers: No Healthy Volunteers

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

Trial design

500 participants in 1 patient group

SCD possitive versus SCD negative group

Description:

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.