Clinical trial NCT03842592: Ventricular Arrhythmia After Myocarditis in Sportsman
Official title: Quantification of Ventricular Arrhythmia After Myocarditis in Sportsman
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myocarditis Acute
Ventricular Arrythmia
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2019-02-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The study aims to assess the prevalence of ventricular rhythmic disorder after an acute myocarditis in sportsmen.

50 patients with acute myocarditis, confirmed by MRI, will be assessed by ECG Holter and Treadmill stress test during a 1-year follow-up.


Eligibility criteria: Inclusion Criteria:

* acute myocarditis, diagnosed on the association of (a) recent viral infection (upper airway, gastro-intestinal) , (b) troponin increase, and (c) chest pain AND myocarditis confirmed by cardiac magnetic resonance 2 out of 3 Lake Louise criteria, either T2 hypersignal, early enhancement or late gadolinium enhancement.
* regular physical activity, recreational or competitive: \>=4 hours weekly
* written informed consent

Exclusion Criteria:

* coronary artery disease
* acute inflammatory cardiomyopathy (sarcoidosis, fulminant myocarditis, Tako Tsubo, eosinophilic myocarditis, Lyme disease)
* history of myocarditis
* contra-indication to cardiac MRI
* patient unable to perform a treadmill stress test

Primary outcomes:
measure: Complex ventricular arrhythmia
timeFrame: any timepoint: 3 month and/or 1 year
Secondary outcomes:
measure: In-hospital ventricular arrhythmia
timeFrame: up to 2 weeks after admission
measure: Left Ventricular remodeling
timeFrame: between baseline and 3 months
measure: Left ventricular fibrosis
timeFrame: between baseline and 3 months
measure: Major adverse cardio vascular event
timeFrame: up to 2 years after inclusion
measure: return to physical activity
timeFrame: up to 2 years after inclusion
Other outcomes:
Locations:
city: Angers
country: France
facility: Angers University Hospital
city: Brest
country: France
facility: Brest University Hospital
city: Paris
country: France
facility: Lariboisière University Hospital - AP-HP
city: Rennes
country: France
facility: Rennes University Hospital
Study officials:
affiliation: Department of Cardiology, University Hospital of Angers (France)
name: Loïc BIERE, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: Maron BJ, Doerer JJ, Haas TS, Tierney DM, Mueller FO. Sudden deaths in young competitive athletes: analysis of 1866 deaths in the United States, 1980-2006. Circulation. 2009 Mar 3;119(8):1085-92. doi: 10.1161/CIRCULATIONAHA.108.804617. Epub 2009 Feb 16.
citation: Maron BJ, Udelson JE, Bonow RO, Nishimura RA, Ackerman MJ, Estes NA 3rd, Cooper LT Jr, Link MS, Maron MS; American Heart Association Electrocardiography and Arrhythmias Committee of Council on Clinical Cardiology, Council on Cardiovascular Disease in Young, Council on Cardiovascular and Stroke Nursing, Council on Functional Genomics and Translational Biology, and American College of Cardiology. Eligibility and Disqualification Recommendations for Competitive Athletes With Cardiovascular Abnormalities: Task Force 3: Hypertrophic Cardiomyopathy, Arrhythmogenic Right Ventricular Cardiomyopathy and Other Cardiomyopathies, and Myocarditis: A Scientific Statement From the American Heart Association and American College of Cardiology. Circulation. 2015 Dec 1;132(22):e273-80. doi: 10.1161/CIR.0000000000000239. Epub 2015 Nov 2. No abstract available.
citation: Friedrich MG, Sechtem U, Schulz-Menger J, Holmvang G, Alakija P, Cooper LT, White JA, Abdel-Aty H, Gutberlet M, Prasad S, Aletras A, Laissy JP, Paterson I, Filipchuk NG, Kumar A, Pauschinger M, Liu P; International Consensus Group on Cardiovascular Magnetic Resonance in Myocarditis. Cardiovascular magnetic resonance in myocarditis: A JACC White Paper. J Am Coll Cardiol. 2009 Apr 28;53(17):1475-87. doi: 10.1016/j.jacc.2009.02.007.
citation: Caforio AL, Pankuweit S, Arbustini E, Basso C, Gimeno-Blanes J, Felix SB, Fu M, Helio T, Heymans S, Jahns R, Klingel K, Linhart A, Maisch B, McKenna W, Mogensen J, Pinto YM, Ristic A, Schultheiss HP, Seggewiss H, Tavazzi L, Thiene G, Yilmaz A, Charron P, Elliott PM; European Society of Cardiology Working Group on Myocardial and Pericardial Diseases. Current state of knowledge on aetiology, diagnosis, management, and therapy of myocarditis: a position statement of the European Society of Cardiology Working Group on Myocardial and Pericardial Diseases. Eur Heart J. 2013 Sep;34(33):2636-48, 2648a-2648d. doi: 10.1093/eurheartj/eht210. Epub 2013 Jul 3.