Ventricular Arrhythmia After Myocarditis in Sportsman

Ventricular Arrythmia Clinical Trial

— ARYMYS  

Official title:

Quantification of Ventricular Arrhythmia After Myocarditis in Sportsman

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03842592
• Other study ID #: 2018-A03328-47
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2019
• Est. completion date: April 2022

Study information

• Verified date: February 2019
• Source: University Hospital, Angers
• Contact: Loïc BIERE, MD PhD
• Phone: +33 241354854
• Email: lobiere[@]chu-angers.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: April 2022
• Est. primary completion date: April 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Myocarditis
• Myocarditis Acute
• Ventricular Arrythmia

Intervention

Diagnostic Test:
• Treadmill Stress test
Ventricular arrhythmia will be assessed by ECG Holter and during treadmill stress test, both being performed 3 months and 1 year after acute myocarditis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

References & Publications (5)

Caforio AL, Pankuweit S, Arbustini E, Basso C, Gimeno-Blanes J, Felix SB, Fu M, Heliö 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. — View 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. — View 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. — View 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. 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complex ventricular arrhythmia	any ventricular tachycardia (triplet or more), ventricular fibrillation (observed on ECG Holter or during stress test)	any timepoint: 3 month and/or 1 year
Secondary	In-hospital ventricular arrhythmia	any ventricular tachycardia (triplet or more), ventricular fibrillation, recorded on ECG monitoring	up to 2 weeks after admission
Secondary	Left Ventricular remodeling	Change in LV volumes during time	between baseline and 3 months
Secondary	Left ventricular fibrosis	Change in interstitial fibrosis by T1 mapping cardiac magnetic resonnance	between baseline and 3 months
Secondary	Major adverse cardio vascular event	CV death, sudden cardiac death, cardiac graft or haemodynamic support, hospitalisation for heart failure, new event of myocarditis	up to 2 years after inclusion
Secondary	return to physical activity	defined as at least 75% of exercising time (in hours per week)	up to 2 years after inclusion