Myocarditis Causing Premature Ventricular Contractions:Insights From the MAVERIC Registry

Myocarditis Clinical Trial

— MAVERIC  

Official title:

Myocarditis Causing Premature Ventricular Contractions:Insights From the MAVERIC Registry

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05158751
• Other study ID #: KCHRF-MAVERIC REG-0009
• Status: Not yet recruiting
• Start date: January 2023
• Est. completion date: May 2023

Study information

• Verified date: November 2021
• Source: Kansas City Heart Rhythm Research Foundation
• Contact: Donita Atkins
• Phone: 816-651-1969
• Email: datkins[@]kchrf.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To assess potential link between unrecognized myocardial inflammation (myocarditis) and premature ventricular contractions (PVCs) associated with and without reduced Left ventricular ejection fraction (LVEF) through comprehensive diagnostic work up.

Description:

Hypothesized that occult inflammation is clinically under-recognized in patients with symptomatic PVCs with and without Left ventricular (LV) dysfunction and can be a potential link between the 2 conditions. Aimed to evaluate the incidence of underlying inflammation using the Positron emission tomography (PET) scan in patients presenting with symptomatic PVCs enrolled retrospectively in the MAVERIC registry.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: May 2023
• Est. primary completion date: January 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients > 18 years of age with mono-morphic or polymorphic PVC burden of =5000 in 24 hours.
• Non-sustained VT was defined as =3 more consecutive beats lasting <30 seconds

Exclusion Criteria:

• History of myocardial infarction,
• Significant flow-limiting coronary artery disease (=50% stenosis) on invasive coronary angiography or CT angiography,
• History of revascularization,
• Significant symptomatic atrial arrhythmias associated with LV dysfunction,
• Severe valvular disease,
• Cardiomyopathy attributed to toxins such as alcohol and illicit drugs,
• History of cardiac arrest,
• History of channelopathies or inherited arrhythmias.

Related Conditions & MeSH terms

• Myocarditis
• Premature Birth
• Premature Ventricular Contractions
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Premature Complexes
• Ventricular Tachycardia (VT)

Locations

Country	Name	City	State
United States	Kansas City Heart Rhythm Institute	Overland Park	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Kansas City Heart Rhythm Research Foundation	Kansas City Heart Rhythm Institute

Country where clinical trial is conducted

United States, 

References & Publications (32)

Ahn MS. Current Concepts of Premature Ventricular Contractions. J Lifestyle Med. 2013 Mar;3(1):26-33. Epub 2013 Mar 31. Review. — View Citation

Chan AK, Dohrmann ML. Management of premature ventricular complexes. Mo Med. 2010 Jan-Feb;107(1):39-43. Review. — View Citation

Dweck MR, Abgral R, Trivieri MG, Robson PM, Karakatsanis N, Mani V, Palmisano A, Miller MA, Lala A, Chang HL, Sanz J, Contreras J, Narula J, Fuster V, Padilla M, Fayad ZA, Kovacic JC. Hybrid Magnetic Resonance Imaging and Positron Emission Tomography With Fluorodeoxyglucose to Diagnose Active Cardiac Sarcoidosis. JACC Cardiovasc Imaging. 2018 Jan;11(1):94-107. doi: 10.1016/j.jcmg.2017.02.021. Epub 2017 Jun 14. — View Citation

Fabre A, Sheppard MN. Sudden adult death syndrome and other non-ischaemic causes of sudden cardiac death. Heart. 2006 Mar;92(3):316-20. Epub 2005 May 27. — View Citation

From AM, Maleszewski JJ, Rihal CS. Current status of endomyocardial biopsy. Mayo Clin Proc. 2011 Nov;86(11):1095-102. doi: 10.4065/mcp.2011.0296. Review. — View Citation

Frustaci A, Chimenti C. Immunosuppressive therapy in virus-negative inflammatory cardiomyopathy. Herz. 2012 Dec;37(8):854-8. doi: 10.1007/s00059-012-3694-x. — View Citation

Frustaci A, Priori SG, Pieroni M, Chimenti C, Napolitano C, Rivolta I, Sanna T, Bellocci F, Russo MA. Cardiac histological substrate in patients with clinical phenotype of Brugada syndrome. Circulation. 2005 Dec 13;112(24):3680-7. — View Citation

Hill MA. Cardiac MR imaging genotoxicity? Eur Heart J. 2018 Jan 21;39(4):313-315. doi: 10.1093/eurheartj/ehx719. — View Citation

Kadkhodayan A, Chareonthaitawee P, Raman SV, Cooper LT. Imaging of Inflammation in Unexplained Cardiomyopathy. JACC Cardiovasc Imaging. 2016 May;9(5):603-17. doi: 10.1016/j.jcmg.2016.01.010. Review. — View Citation

Kang M, An J. Viral Myocarditis. [Updated 2019 Mar 8]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2020 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK459259

Kastor JA. Ventricular premature beats. Adv Intern Med. 1983;28:63-91. Review. — View Citation

Kaushik A, Jaimini A, Tripathi M, D'Souza M, Sharma R, Mondal A, Mishra AK, Dwarakanath BS. Estimation of radiation dose to patients from (18) FDG whole body PET/CT investigations using dynamic PET scan protocol. Indian J Med Res. 2015 Dec;142(6):721-31. doi: 10.4103/0971-5916.174563. — View Citation

Kennedy HL, Whitlock JA, Sprague MK, Kennedy LJ, Buckingham TA, Goldberg RJ. Long-term follow-up of asymptomatic healthy subjects with frequent and complex ventricular ectopy. N Engl J Med. 1985 Jan 24;312(4):193-7. — View Citation

Kindermann I, Barth C, Mahfoud F, Ukena C, Lenski M, Yilmaz A, Klingel K, Kandolf R, Sechtem U, Cooper LT, Böhm M. Update on myocarditis. J Am Coll Cardiol. 2012 Feb 28;59(9):779-92. doi: 10.1016/j.jacc.2011.09.074. Review. — View Citation

Lakkireddy D, Turagam MK, Yarlagadda B, Dar T, Hamblin M, Krause M, Parikh V, Bommana S, Atkins D, Di Biase L, Mohanty S, Rosamond T, Carroll H, Nydegger C, Wetzel L, Gopinathannair R, Natale A. Myocarditis Causing Premature Ventricular Contractions: Insights From the MAVERIC Registry. Circ Arrhythm Electrophysiol. 2019 Dec;12(12):e007520. doi: 10.1161/CIRCEP.119.007520. Epub 2019 Dec 16. — View Citation

Mattsson G, Magnusson P. Electrical storm in the inflamed heart: ventricular tachycardia due to myocarditis. Clin Case Rep. 2017 Jul 3;5(8):1327-1332. doi: 10.1002/ccr3.1071. eCollection 2017 Aug. — View Citation

Merken J, Hazebroek M, Van Paassen P, Verdonschot J, Van Empel V, Knackstedt C, Abdul Hamid M, Seiler M, Kolb J, Hoermann P, Ensinger C, Brunner-La Rocca HP, Poelzl G, Heymans S. Immunosuppressive Therapy Improves Both Short- and Long-Term Prognosis in Patients With Virus-Negative Nonfulminant Inflammatory Cardiomyopathy. Circ Heart Fail. 2018 Feb;11(2):e004228. doi: 10.1161/CIRCHEARTFAILURE.117.004228. — View Citation

Ms Alina Scridon Mr Philippe Chevalier , FESC. Ventricular arrhythmias complicating acute myocarditis. ESC Council for Cardiology Practice Vol. 9, N° 26 - 05 Apr 2011

Ng GA. Treating patients with ventricular ectopic beats. Heart. 2006 Nov;92(11):1707-12. Review. — View Citation

Peretto G, Sala S, Rizzo S, Palmisano A, Esposito A, De Cobelli F, Campochiaro C, De Luca G, Foppoli L, Dagna L, Thiene G, Basso C, Della Bella P. Ventricular Arrhythmias in Myocarditis: Characterization and Relationships With Myocardial Inflammation. J Am Coll Cardiol. 2020 Mar 10;75(9):1046-1057. doi: 10.1016/j.jacc.2020.01.036. — View Citation

Piccolo E, Raviele A. [Clinical and prognostic significance of hyperkinetic ventricular arrhythmias]. G Ital Cardiol. 1983;13(4):276-89. Review. Italian. — View Citation

Podrid PJ. Safety and toxicity of antiarrhythmic drug therapy: benefit versus risk. J Cardiovasc Pharmacol. 1991;17 Suppl 6:S65-73. Review. — View Citation

Ruberman W, Weinblatt E, Goldberg JD, Frank CW, Shapiro S. Ventricular premature beats and mortality after myocardial infarction. N Engl J Med. 1977 Oct 6;297(14):750-7. — View Citation

Salerno F, Girerd N, Chalabreysse L, Billaud G, Lina B, Chevalier P. Myocarditis and cardiac channelopathies: a deadly association? Int J Cardiol. 2011 Mar 17;147(3):468-70. doi: 10.1016/j.ijcard.2011.01.019. Epub 2011 Feb 3. — View Citation

Singh JA, Hossain A, Kotb A, Wells G. Risk of serious infections with immunosuppressive drugs and glucocorticoids for lupus nephritis: a systematic review and network meta-analysis. BMC Med. 2016 Sep 13;14(1):137. doi: 10.1186/s12916-016-0673-8. Review. — View Citation

Te ALD, Wu TC, Lin YJ, Chen YY, Chung FP, Chang SL, Lo LW, Hu YF, Tuan TC, Chao TF, Liao JN, Chien KL, Lin CY, Chang YT, Chen SA. Increased risk of ventricular tachycardia and cardiovascular death in patients with myocarditis during the long-term follow-up: A national representative cohort from the National Health Insurance Research Database. Medicine (Baltimore). 2017 May;96(18):e6633. doi: 10.1097/MD.0000000000006633. — View Citation

Tschöpe C, Cooper LT, Torre-Amione G, Van Linthout S. Management of Myocarditis-Related Cardiomyopathy in Adults. Circ Res. 2019 May 24;124(11):1568-1583. doi: 10.1161/CIRCRESAHA.118.313578. Review. — View Citation

Vial T, Descotes J. Immunosuppressive drugs and cancer. Toxicology. 2003 Apr 1;185(3):229-40. Review. — View Citation

Whiting RB. Ventricular premature contractions. Which should be treated? Arch Intern Med. 1980 Nov;140(11):1423-6. Review. — View Citation

Wicks EC, Menezes LJ, Barnes A, Mohiddin SA, Sekhri N, Porter JC, Booth HL, Garrett E, Patel RS, Pavlou M, Groves AM, Elliott PM. Diagnostic accuracy and prognostic value of simultaneous hybrid 18F-fluorodeoxyglucose positron emission tomography/magnetic resonance imaging in cardiac sarcoidosis. Eur Heart J Cardiovasc Imaging. 2018 Jul 1;19(7):757-767. doi: 10.1093/ehjci/jex340. — View Citation

Wojnicz R, Nowalany-Kozielska E, Wojciechowska C, Glanowska G, Wilczewski P, Niklewski T, Zembala M, Polonski L, Rozek MM, Wodniecki J. Randomized, placebo-controlled study for immunosuppressive treatment of inflammatory dilated cardiomyopathy: two-year follow-up results. Circulation. 2001 Jul 3;104(1):39-45. — View Citation

Wu AH. Management of patients with non-ischaemic cardiomyopathy. Heart. 2007 Mar;93(3):403-8. Review. — View Citation

* Note: There are 32 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Evaluate whether IST + catheter ablation results in optimal clinical response	To evaluate whether IST + catheter ablation results in optimal clinical response in virus negative and FDG-PET positive patients with PVCs with or without reduced LVEF	Retrospective Collection between dates January 2014-January 2023
Primary	Identify the underlying myocarditis in patients presenting with PVCs with or without reduced LVEF	To identify the underlying myocarditis in patients presenting with PVCs with or without reduced LVEF through laboratory testing, FDG-PET(18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose - positron emission tomography) scan, Cardiac Magnetic Resonance imaging and/or Endomyocardial biopsy.	Retrospective Collection between dates January 2014-January 2023
Secondary	Ascertain whether immunosuppressive therapy (IST) affords short term and long term improvement of LVEF and clinical outcomes	To ascertain whether immunosuppressive therapy (IST) affords short term and long term improvement of LVEF and clinical outcomes in virus negative and FDG-PET positive patients with non-ischemic cardiomyopathy, myocardial inflammation and PVCs.	Retrospective Collection between dates January 2014-January 2023