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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03842592
Other study ID # 2018-A03328-47
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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