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Arrhythmia Prediction Trial

Arrhythmia Prediction Trial and Risk Stratification in Heart Failure Patients - Athens.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02175836
Acronym
APRET
Enrollment
500
Registered
2014-06-26
Start date
2007-10-31
Completion date
2019-06-30
Last updated
2016-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dilated Cardiomyopathy, Heart Failure, Myocardial Infarction

Keywords

Arrhythmic Sudden Cardiac Death, Heart Failure, Risk Stratification, Autonomic Nervous System, Heart Rate, Repolarization

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.

Interventions

None listed

Sponsors

University of Athens
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 82 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Sudden Cardiac Death surrogates: 1.Clinical Ventricular Tachyarrhythmia, 2.ICD's appropriate activation, 3.Confirmed Sudden Cardiac Death2007-2019 (12 years)

Secondary

MeasureTime frame
Total Mortality2007-2019 (12 years)

Countries

Greece

Contacts

Primary ContactPetros Arsenos, MD, PhD
arspetr@otenet.gr00306974338896

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026