Arrhythmia Prediction Trial

Heart Failure Clinical Trial

— APRET  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02175836
• Other study ID #: 17/25-10-2006
• Secondary ID: APRET, Athens Me
• Status: Recruiting
• Phase: N/A
• First received: June 24, 2014
• Last updated: January 27, 2016
• Start date: October 2007
• Est. completion date: June 2019

Study information

• Verified date: January 2016
• Source: University of Athens
• Contact: Petros Arsenos, MD, PhD
• Phone: 00306974338896
• Email: arspetr[@]otenet.gr
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Dilated
• Dilated Cardiomyopathy
• Heart Failure
• Myocardial Infarction

Locations

Country	Name	City	State
Greece	First Department of Cardiology, Medical School, National & Kapodistrian University of Athens	Athens

Sponsors (1)

Lead Sponsor	Collaborator
University of Athens

Country where clinical trial is conducted

Greece, 

References & Publications (23)

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

De Ferrari GM, Rordorf R, Frattini F, Petracci B, De Filippo P, Landolina M. Predictive value of programmed ventricular stimulation in patients with ischaemic cardiomyopathy: implications for the selection of candidates for an implantable defibrillator. Europace. 2007 Dec;9(12):1151-7. Epub 2007 Oct 17. — View Citation

Exner DV, Kavanagh KM, Slawnych MP, Mitchell LB, Ramadan D, Aggarwal SG, Noullett C, Van Schaik A, Mitchell RT, Shibata MA, Gulamhussein S, McMeekin J, Tymchak W, Schnell G, Gillis AM, Sheldon RS, Fick GH, Duff HJ; REFINE Investigators. Noninvasive risk assessment early after a myocardial infarction the REFINE study. J Am Coll Cardiol. 2007 Dec 11;50(24):2275-84. Epub 2007 Nov 26. — 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 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

Gatzoulis KA, Vouliotis AI, Tsiachris D, Salourou M, Archontakis S, Dilaveris P, Gialernios T, Arsenos P, Karystinos G, Sideris S, Kallikazaros I, Stefanadis C. Primary prevention of sudden cardiac death in a nonischemic dilated cardiomyopathy population: reappraisal of the role of programmed ventricular stimulation. Circ Arrhythm Electrophysiol. 2013 Jun;6(3):504-12. doi: 10.1161/CIRCEP.113.000216. Epub 2013 Apr 15. — View Citation

Gomes JA, Cain ME, Buxton AE, Josephson ME, Lee KL, Hafley GE. Prediction of long-term outcomes by signal-averaged electrocardiography in patients with unsustained ventricular tachycardia, coronary artery disease, and left ventricular dysfunction. Circulation. 2001 Jul 24;104(4):436-41. — View Citation

Huikuri HV, Mäkikallio TH, Raatikainen MJ, Perkiömäki J, Castellanos A, Myerburg RJ. Prediction of sudden cardiac death: appraisal of the studies and methods assessing the risk of sudden arrhythmic death. Circulation. 2003 Jul 8;108(1):110-5. Review. — View Citation

Huikuri HV, Raatikainen MJ, Moerch-Joergensen R, Hartikainen J, Virtanen V, Boland J, Anttonen O, Hoest N, Boersma LV, Platou ES, Messier MD, Bloch-Thomsen PE; Cardiac Arrhythmias and Risk Stratification after Acute Myocardial Infarction study group. Prediction of fatal or near-fatal cardiac arrhythmia events in patients with depressed left ventricular function after an acute myocardial infarction. Eur Heart J. 2009 Mar;30(6):689-98. doi: 10.1093/eurheartj/ehn537. Epub 2009 Jan 20. — View Citation

Mäkikallio TH, Barthel P, Schneider R, Bauer A, Tapanainen JM, Tulppo MP, Schmidt G, Huikuri HV. Prediction of sudden cardiac death after acute myocardial infarction: role of Holter monitoring in the modern treatment era. Eur Heart J. 2005 Apr;26(8):762-9. Epub 2005 Mar 18. — View Citation

Merchant FM, Zheng H, Bigger T, Steinman R, Ikeda T, Pedretti RF, Salerno-Uriarte JA, Klersy C, Chan PS, Bartone C, Hohnloser SH, Ruskin JN, Armoundas AA. A combined anatomic and electrophysiologic substrate based approach for sudden cardiac death risk stratification. Am Heart J. 2013 Oct;166(4):744-52. doi: 10.1016/j.ahj.2013.06.023. Epub 2013 Sep 18. Review. — View Citation

Mirowski M, Mower MM, Langer A, Heilman MS, Schreibman J. A chronically implanted system for automatic defibrillation in active conscious dogs. Experimental model for treatment of sudden death from ventricular fibrillation. Circulation. 1978 Jul;58(1):90-4. — View Citation

Moss AJ, Zareba W, Hall WJ, Klein H, Wilber DJ, Cannom DS, Daubert JP, Higgins SL, Brown MW, Andrews ML; Multicenter Automatic Defibrillator Implantation Trial II Investigators. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med. 2002 Mar 21;346(12):877-83. Epub 2002 Mar 19. — View Citation

Myerburg RJ. Sudden cardiac death: exploring the limits of our knowledge. J Cardiovasc Electrophysiol. 2001 Mar;12(3):369-81. Review. — View Citation

Schwartz PJ, Wolf S. QT interval prolongation as predictor of sudden death in patients with myocardial infarction. Circulation. 1978 Jun;57(6):1074-7. — View Citation

Schwartz PJ. The autonomic nervous system and sudden death. Eur Heart J. 1998 Jun;19 Suppl F:F72-80. Review. — View Citation

Wellens HJ, Schwartz PJ, Lindemans FW, Buxton AE, Goldberger JJ, Hohnloser SH, Huikuri HV, Kääb S, La Rovere MT, Malik M, Myerburg RJ, Simoons ML, Swedberg K, Tijssen J, Voors AA, Wilde AA. Risk stratification for sudden cardiac death: current status and challenges for the future. Eur Heart J. 2014 Jul 1;35(25):1642-51. doi: 10.1093/eurheartj/ehu176. Epub 2014 May 5. — View Citation

* Note: There are 23 references in all — Click here to view all references

Outcome

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

External Links

•   Link