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Arrhythmia Prediction Trial (APRET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02175836
Recruitment Status : Unknown
Verified January 2016 by PETROS ARSENOS, University of Athens.
Recruitment status was:  Recruiting
First Posted : June 26, 2014
Last Update Posted : January 28, 2016
Information provided by (Responsible Party):
PETROS ARSENOS, 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.

Condition or disease
Myocardial Infarction Dilated Cardiomyopathy Heart Failure

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.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Arrhythmia Prediction Trial and Risk Stratification in Heart Failure Patients - Athens.
Study Start Date : October 2007
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

SCD possitive versus SCD negative group
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.

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Total Mortality [ Time Frame: 2007-2019 (12 years) ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   20 Years to 82 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Heart Failure Patients with Myoacardial Infarction and Dilated Cardiomyopathy maintaining sinus rhyhtm.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02175836

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Contact: Petros Arsenos, MD, PhD 00306974338896

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First Department of Cardiology, Medical School, National & Kapodistrian University of Athens Recruiting
Athens, Greece, 11527
Contact: Petros Arsenos, MD, PhD    00306974338896   
Principal Investigator: Petros Arsenos, MD, PhD         
Sponsors and Collaborators
University of Athens
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Principal Investigator: Petros Arsenos, MD, PhD First Department of Cardiology, Medical School, National & Kapodistrian University of Athens, Greece
Additional Information:

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Responsible Party: PETROS ARSENOS, MD, PhD, University of Athens Identifier: NCT02175836    
Other Study ID Numbers: 17/25-10-2006
APRET, Athens Medical School ( Other Identifier: Athens Medical School )
First Posted: June 26, 2014    Key Record Dates
Last Update Posted: January 28, 2016
Last Verified: January 2016
Keywords provided by PETROS ARSENOS, University of Athens:
Arrhythmic Sudden Cardiac Death
Heart Failure
Risk Stratification
Autonomic Nervous System
Heart Rate
Additional relevant MeSH terms:
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Heart Failure
Myocardial Infarction
Cardiomyopathy, Dilated
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Myocardial Ischemia
Vascular Diseases