Heart Failure Clinical Trial
— APRETOfficial title:
Arrhythmia Prediction Trial and Risk Stratification in Heart Failure Patients - Athens.
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.
Status | Recruiting |
Enrollment | 500 |
Est. completion date | June 2019 |
Est. primary completion date | June 2019 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 82 Years |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Greece | First Department of Cardiology, Medical School, National & Kapodistrian University of Athens | Athens |
Lead Sponsor | Collaborator |
---|---|
University of Athens |
Greece,
Arsenos P, Gatzoulis K, Dilaveris P, Manis G, Tsiachris D, Archontakis S, Vouliotis AI, Sideris S, Stefanadis C. Arrhythmic sudden cardiac death: substrate, mechanisms and current risk stratification strategies for the post-myocardial infarction patient. Hellenic J Cardiol. 2013 Jul-Aug;54(4):301-15. Review. Erratum in: Hellenic J Cardiol. 2015 May-Jun;56(3):273. Vouliotis, Apostolis H [corrected to Vouliotis, Apostolos-Ilias]. — View Citation
Arsenos P, Gatzoulis K, Manis G, Gialernios T, Dilaveris P, Tsiachris D, Archontakis S, Kartsagoulis E, Mytas D, Stefanadis C. Decreased scale-specific heart rate variability after multiresolution wavelet analysis predicts sudden cardiac death in heart failure patients. Int J Cardiol. 2012 Feb 9;154(3):358-60. doi: 10.1016/j.ijcard.2011.11.007. Epub 2011 Nov 30. — View Citation
Arsenos P, Gatzoulis KA, Dilaveris P, Gialernios T, Sideris S, Lazaros G, Archontakis S, Tsiachris D, Kartsagoulis E, Stefanadis C. The rate-corrected QT interval calculated from 24-hour Holter recordings may serve as a significant arrhythmia risk stratifier in heart failure patients. Int J Cardiol. 2011 Mar 3;147(2):321-3. doi: 10.1016/j.ijcard.2010.12.076. Epub 2011 Jan 15. — View Citation
Arsenos P, Gatzoulis KA, Gialernios T, Dilaveris P, Tsiachris D, Archontakis S, Vouliotis AI, Raftopoulos L, Manis G, Stefanadis C. Elevated nighttime heart rate due to insufficient circadian adaptation detects heart failure patients prone for malignant ventricular arrhythmias. Int J Cardiol. 2014;172(1):e154-6. doi: 10.1016/j.ijcard.2013.12.075. Epub 2013 Dec 28. — View Citation
Bauer A, Barthel P, Müller A, Ulm K, Huikuri H, Malik M, Schmidt G. Risk prediction by heart rate turbulence and deceleration capacity in postinfarction patients with preserved left ventricular function retrospective analysis of 4 independent trials. J Electrocardiol. 2009 Nov-Dec;42(6):597-601. doi: 10.1016/j.jelectrocard.2009.07.013. — View Citation
Bauer A, Barthel P, Schneider R, Ulm K, Müller A, Joeinig A, Stich R, Kiviniemi A, Hnatkova K, Huikuri H, Schömig A, Malik M, Schmidt G. Improved Stratification of Autonomic Regulation for risk prediction in post-infarction patients with preserved left ventricular function (ISAR-Risk). Eur Heart J. 2009 Mar;30(5):576-83. doi: 10.1093/eurheartj/ehn540. Epub 2008 Dec 23. — View Citation
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Gatzoulis KA, Archontakis S, Dilaveris P, Tsiachris D, Arsenos P, Sideris S, Stefanadis C. Ventricular arrhythmias: from the electrophysiology laboratory to clinical practice. Part I: malignant ventricular arrhythmias. Hellenic J Cardiol. 2011 Nov-Dec;52(6):525-35. Review. — View Citation
Gatzoulis KA, Archontakis S, Dilaveris P, Tsiachris D, Arsenos P, Sideris S, Stefanadis C. Ventricular arrhythmias: from the electrophysiology laboratory to clinical practice. Part II: potentially malignant and benign ventricular arrhythmias. Hellenic J Cardiol. 2012 May-Jun;53(3):217-33. Review. — View Citation
Gatzoulis KA, Tsiachris D, Dilaveris P, Archontakis S, Arsenos P, Vouliotis A, Sideris S, Trantalis G, Kartsagoulis E, Kallikazaros I, Stefanadis C. Implantable cardioverter defibrillator therapy activation for high risk patients with relatively well preserved left ventricular ejection fraction. Does it really work? Int J Cardiol. 2013 Aug 20;167(4):1360-5. doi: 10.1016/j.ijcard.2012.04.005. Epub 2012 Apr 24. — View Citation
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* Note: There are 23 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sudden Cardiac Death surrogates: 1.Clinical Ventricular Tachyarrhythmia, 2.ICD's appropriate activation, 3.Confirmed Sudden Cardiac Death | 2007-2019 (12 years) | No | |
Secondary | Total Mortality | 2007-2019 (12 years) | No |
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