NCT03842592

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2019

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 15, 2019

Completed
9 months until next milestone

Study Start

First participant enrolled

November 6, 2019

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

February 25, 2025

Status Verified

February 1, 2025

Enrollment Period

6 years

First QC Date

January 28, 2019

Last Update Submit

February 21, 2025

Conditions

Myocarditis AcuteVentricular Arrythmia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • In-hospital ventricular arrhythmia

    up to 2 weeks after admission

  • Left Ventricular remodeling

    between baseline and 3 months

  • Left ventricular fibrosis

    between baseline and 3 months

  • Major adverse cardio vascular event

    up to 2 years after inclusion

  • return to physical activity

    up to 2 years after inclusion

Study Arms (1)

To establish the rhythmic load of sports patients at a distance from a first episode of myocarditis.

OTHER

Stress 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.

Diagnostic Test: Treadmill Stress test

Interventions

Treadmill Stress testDIAGNOSTIC_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

Also known as: ECG Holter
To establish the rhythmic load of sports patients at a distance from a first episode of myocarditis.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Angers University Hospital

Angers, France

RECRUITING

Brest University Hospital

Brest, France

RECRUITING

Lariboisière University Hospital - AP-HP

Paris, France

RECRUITING

Rennes University Hospital

Rennes, France

RECRUITING

Related Publications (5)

  • 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.

    PMID: 28471960BACKGROUND

  • 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.

    PMID: 19221222BACKGROUND

  • 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.

    PMID: 26621644BACKGROUND

  • 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.

    PMID: 19389557BACKGROUND

  • 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.

    PMID: 23824828BACKGROUND

MeSH Terms

Interventions

Exercise TestElectrocardiography, Ambulatory

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative TechniquesElectrocardiographyElectrodiagnosisMonitoring, AmbulatoryMonitoring, Physiologic

Study Officials

  • Loïc BIERE, MD PhD

    Department of Cardiology, University Hospital of Angers (France)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Loïc BIERE, MD PhD

CONTACT

+33 241354854lobiere@chu-angers.fr

Fabrice PRUNIER, MD PhD

CONTACT

+33 241354858

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2019

First Posted

February 15, 2019

Study Start

November 6, 2019

Primary Completion

November 1, 2025

Study Completion

February 1, 2026

Last Updated

February 25, 2025

Record last verified: 2025-02

Locations

FR(4)