Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-01-01 @ 6:43 PM
Study NCT ID:
NCT05158751
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-04
First Post:
2021-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Myocarditis Causing Premature Ventricular Contractions:Insights From the MAVERIC Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009205', 'term': 'Myocarditis'}, {'id': 'D018879', 'term': 'Ventricular Premature Complexes'}, {'id': 'D017180', 'term': 'Tachycardia, Ventricular'}], 'ancestors': [{'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D005117', 'term': 'Cardiac Complexes, Premature'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013610', 'term': 'Tachycardia'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-27', 'studyFirstSubmitDate': '2021-12-02', 'studyFirstSubmitQcDate': '2021-12-02', 'lastUpdatePostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-12-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Evaluate whether IST + catheter ablation results in optimal clinical response', 'timeFrame': 'Retrospective Collection between dates January 2014-January 2023', 'description': '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'}], 'primaryOutcomes': [{'measure': 'Identify the underlying myocarditis in patients presenting with PVCs with or without reduced LVEF', 'timeFrame': 'Retrospective Collection between dates January 2014-January 2023', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Ascertain whether immunosuppressive therapy (IST) affords short term and long term improvement of LVEF and clinical outcomes', 'timeFrame': 'Retrospective Collection between dates January 2014-January 2023', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myocarditis', 'Premature Ventricular Contractions', 'Ventricular Tachycardia (VT)']}, 'referencesModule': {'references': [{'pmid': '26064834', 'type': 'BACKGROUND', 'citation': 'Ahn MS. Current Concepts of Premature Ventricular Contractions. J Lifestyle Med. 2013 Mar;3(1):26-33. Epub 2013 Mar 31.'}, {'pmid': '17041126', 'type': 'BACKGROUND', 'citation': 'Ng GA. Treating patients with ventricular ectopic beats. Heart. 2006 Nov;92(11):1707-12. doi: 10.1136/hrt.2005.067843. No abstract available.'}, {'pmid': '2578212', 'type': 'BACKGROUND', '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. doi: 10.1056/NEJM198501243120401.'}, {'pmid': '31838913', 'type': 'BACKGROUND', '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.'}, {'pmid': '70750', 'type': 'BACKGROUND', '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. doi: 10.1056/NEJM197710062971404.'}, {'pmid': '6159832', 'type': 'BACKGROUND', 'citation': 'Whiting RB. Ventricular premature contractions. Which should be treated? Arch Intern Med. 1980 Nov;140(11):1423-6.'}, {'pmid': '6350092', 'type': 'BACKGROUND', 'citation': 'Piccolo E, Raviele A. [Clinical and prognostic significance of hyperkinetic ventricular arrhythmias]. G Ital Cardiol. 1983;13(4):276-89. Italian.'}, {'pmid': '6340432', 'type': 'BACKGROUND', 'citation': 'Kastor JA. Ventricular premature beats. Adv Intern Med. 1983;28:63-91.'}, {'pmid': '17322525', 'type': 'BACKGROUND', 'citation': 'Wu AH. Management of patients with non-ischaemic cardiomyopathy. Heart. 2007 Mar;93(3):403-8. doi: 10.1136/hrt.2005.085761. No abstract available.'}, {'pmid': '31120823', 'type': 'BACKGROUND', 'citation': 'Tschope 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.'}, {'pmid': '28781852', 'type': 'BACKGROUND', '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.'}, {'type': 'BACKGROUND', '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'}, {'pmid': '16344400', 'type': 'BACKGROUND', '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. doi: 10.1161/CIRCULATIONAHA.105.520999.'}, {'pmid': '21295362', 'type': 'BACKGROUND', '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. No abstract available.'}, {'pmid': '28471960', 'type': 'BACKGROUND', '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.'}, {'type': 'BACKGROUND', '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'}, {'pmid': '11435335', 'type': 'BACKGROUND', '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. doi: 10.1161/01.cir.104.1.39.'}, {'pmid': '32138965', 'type': 'BACKGROUND', '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.'}, {'pmid': '22033254', 'type': 'BACKGROUND', '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.'}, {'pmid': '28624396', 'type': 'BACKGROUND', '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.'}, {'pmid': '29319785', 'type': 'BACKGROUND', '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.'}, {'pmid': '27151523', 'type': 'BACKGROUND', '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.'}, {'pmid': '29449368', 'type': 'BACKGROUND', '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.'}, {'pmid': '23080270', 'type': 'BACKGROUND', '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.'}, {'pmid': '20222294', 'type': 'BACKGROUND', 'citation': 'Chan AK, Dohrmann ML. Management of premature ventricular complexes. Mo Med. 2010 Jan-Feb;107(1):39-43.'}, {'pmid': '22361396', 'type': 'BACKGROUND', 'citation': 'Kindermann I, Barth C, Mahfoud F, Ukena C, Lenski M, Yilmaz A, Klingel K, Kandolf R, Sechtem U, Cooper LT, Bohm M. Update on myocarditis. J Am Coll Cardiol. 2012 Feb 28;59(9):779-92. doi: 10.1016/j.jacc.2011.09.074.'}, {'pmid': '15923280', 'type': 'BACKGROUND', '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. doi: 10.1136/hrt.2004.045518. Epub 2005 May 27.'}, {'pmid': '12581698', 'type': 'BACKGROUND', 'citation': 'Vial T, Descotes J. Immunosuppressive drugs and cancer. Toxicology. 2003 Apr 1;185(3):229-40. doi: 10.1016/s0300-483x(02)00612-1.'}, {'pmid': '27623861', 'type': 'BACKGROUND', '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.'}, {'pmid': '26831421', 'type': 'BACKGROUND', '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."}, {'pmid': '29281062', 'type': 'BACKGROUND', 'citation': 'Hill MA. Cardiac MR imaging genotoxicity? Eur Heart J. 2018 Jan 21;39(4):313-315. doi: 10.1093/eurheartj/ehx719. No abstract available.'}, {'pmid': '1723122', 'type': 'BACKGROUND', 'citation': 'Podrid PJ. Safety and toxicity of antiarrhythmic drug therapy: benefit versus risk. J Cardiovasc Pharmacol. 1991;17 Suppl 6:S65-73.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Males and females with PVC and ventricular tachycardia (VT) will be enrolled if they meet the inclusion/exclusion criteria', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients \\> 18 years of age with mono-morphic or polymorphic PVC burden of ≥5000 in 24 hours.\n* Non-sustained VT was defined as ≥3 more consecutive beats lasting \\<30 seconds\n\nExclusion Criteria:\n\n* History of myocardial infarction,\n* Significant flow-limiting coronary artery disease (≥50% stenosis) on invasive coronary angiography or CT angiography,\n* History of revascularization,\n* Significant symptomatic atrial arrhythmias associated with LV dysfunction,\n* Severe valvular disease,\n* Cardiomyopathy attributed to toxins such as alcohol and illicit drugs,\n* History of cardiac arrest,\n* History of channelopathies or inherited arrhythmias.'}, 'identificationModule': {'nctId': 'NCT05158751', 'acronym': 'MAVERIC', 'briefTitle': 'Myocarditis Causing Premature Ventricular Contractions:Insights From the MAVERIC Registry', 'organization': {'class': 'OTHER', 'fullName': 'Kansas City Heart Rhythm Research Foundation'}, 'officialTitle': 'Myocarditis Causing Premature Ventricular Contractions:Insights From the MAVERIC Registry', 'orgStudyIdInfo': {'id': 'KCHRF-MAVERIC REG-0009'}}, 'contactsLocationsModule': {'locations': [{'zip': '66211', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'contacts': [{'name': 'Donita Atkins', 'role': 'CONTACT', 'email': 'Donita.Atkins@kchrf.com', 'phone': '816-651-1969'}], 'facility': 'Kansas City Heart Rhythm Institute', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}], 'centralContacts': [{'name': 'Donita Atkins', 'role': 'CONTACT', 'email': 'datkins@kchrf.com', 'phone': '816-651-1969'}], 'overallOfficials': [{'name': 'Dhanunjaya Lakkireddy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kansas City Heart Rhythm Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kansas City Heart Rhythm Research Foundation', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kansas City Heart Rhythm Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}