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Arrhythmia Prediction Trial (APRET)

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ClinicalTrials.gov Identifier: NCT02175836
Recruitment Status : Recruiting
First Posted : June 26, 2014
Last Update Posted : January 28, 2016
Sponsor:
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


Group/Cohort
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) ]


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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.
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

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 ClinicalTrials.gov identifier (NCT number): NCT02175836


Contacts
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Contact: Petros Arsenos, MD, PhD 00306974338896 arspetr@otenet.gr

Locations
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Greece
First Department of Cardiology, Medical School, National & Kapodistrian University of Athens Recruiting
Athens, Greece, 11527
Contact: Petros Arsenos, MD, PhD    00306974338896    arspetr@otenet.gr   
Principal Investigator: Petros Arsenos, MD, PhD         
Sponsors and Collaborators
University of Athens
Investigators
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Principal Investigator: Petros Arsenos, MD, PhD First Department of Cardiology, Medical School, National & Kapodistrian University of Athens, Greece

Additional Information:
Publications:

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Responsible Party: PETROS ARSENOS, MD, PhD, University of Athens
ClinicalTrials.gov Identifier: NCT02175836     History of Changes
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
Repolarization

Additional relevant MeSH terms:
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Heart Failure
Infarction
Myocardial Infarction
Cardiomyopathies
Cardiomyopathy, Dilated
Heart Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Vascular Diseases
Cardiomegaly