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Myocarditis AcuteARYMYSNCT03842592

Ventricular Arrhythmia After Myocarditis in Sportsman

A study testing Treadmill Stress test in people with Myocarditis Acute and Ventricular Arrythmia, run by University Hospital, Angers at 4 sites in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myocarditis Acute, Ventricular Arrythmia
What is being tested?
Treadmill Stress test
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
4 sitesFrance
Study dates
6 Nov 2019to Feb 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

4 sites in 1 country.

France4 sites

  • Angers University Hospital

    Angers

  • Brest University Hospital

    Brest

  • Lariboisière University Hospital - AP-HP

    Paris

  • Rennes University Hospital

    Rennes

Other trials in France

About this study

Official title: Quantification of Ventricular Arrhythmia After Myocarditis in Sportsman

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.

Being tested
Treadmill Stress test

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Treadmill Stress testDiagnostic test

    Also called ECG Holter

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

Study groups in NCT03842592
Study groupRoleWhat they receive
To establish the rhythmic load of sports patients at a distance from a first episode of myocarditis.OtherStress testing and 24-hour Holter ECG are the tools currently recommended for assessing rhythmic load and, consequently rhythmic risk. These investigations will be perform at 1 years after myocardite.
Receives: Diagnostic Test: Treadmill Stress test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complex ventricular arrhythmia

    any ventricular tachycardia (triplet or more), ventricular fibrillation (observed on ECG Holter or during stress test)

    Measured: any timepoint: 3 month and/or 1 year

Secondary outcomes (5)

  1. In-hospital ventricular arrhythmia

    any ventricular tachycardia (triplet or more), ventricular fibrillation, recorded on ECG monitoring

    Measured: up to 2 weeks after admission

  2. Left Ventricular remodeling

    Change in LV volumes during time

    Measured: between baseline and 3 months

  3. Left ventricular fibrosis

    Change in interstitial fibrosis by T1 mapping cardiac magnetic resonnance

    Measured: between baseline and 3 months

  4. Major adverse cardio vascular event

    CV death, sudden cardiac death, cardiac graft or haemodynamic support, hospitalisation for heart failure, new event of myocarditis

    Measured: up to 2 years after inclusion

  5. return to physical activity

    defined as at least 75% of exercising time (in hours per week)

    Measured: up to 2 years after inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2019
  2. Study start6 Nov 2019
  3. Primary completionNov 2027 (estimated)
  4. Study completionFeb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03842592
Sponsor's protocol ID
2018-A03328-47
Acronym
ARYMYS
Status last verified
Mar 2026
First submitted
28 Jan 2019
Last updated
6 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 28471960

  • 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.

    PubMed 19221222

  • 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.

    PubMed 26621644

  • 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.

    PubMed 19389557

  • 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.

    PubMed 23824828

Questions about this trial

What is this clinical trial studying?

A study testing Treadmill Stress test in people with Myocarditis Acute and Ventricular Arrythmia, run by University Hospital, Angers at 4 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complex ventricular arrhythmia (time frame: any timepoint: 3 month and/or 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03842592, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.

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