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MyocarditisRAMNCT04589156

Recurrent Acute Myocarditis Registry

An observational study of Myocarditis and Cardiomyopathy, run by University Hospital, Caen at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The association between myocardial inflammation (clinically represented by acute myocarditis episodes) and the later development of an arrhythmogenic cardiomyopathy is widely elusive. Read more about this study

Who is it for?
Any age
Conditions the study is for
Myocarditis, Cardiomyopathy
How many people
20 participants
Where
1 siteFrance
Study dates
1 Jan 2018to 1 Jan 2022
How long will I take part?
2 Years
Phase
Observational
Are there results?
None posted in the registry

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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients with recurrent acute myocarditis.

Inclusion Criteria: patients with at least two episodes of acute myocarditis as defined by the European Society of Cardiology diagnostic criteria.

Trial locations and contacts

1 site in 1 country.

Pierre Ollitrault, MD, MSc contact

0231064418

ollitrault-p@chu-caen.fr

France1 site, 1 recruiting

  • Caen University Hospital

    Caen, Normandy, F-14000

    Pierre Ollitrault, MD, MSc, 0231064418, ollitrault-p@chu-caen.fr

    Pierre Ollitrault, MD, MSc

    Recruiting

Other trials in France

About this study

Official title: Recurrent Acute Myocarditis : Characteristics, Etiology, Prognosis and Genetic Basis.

The association between myocardial inflammation (clinically represented by acute myocarditis episodes) and the later development of an arrhythmogenic cardiomyopathy is widely elusive.

Read the detailed description

Acute myocarditis (AM) is an inflammatory disease of the myocardium caused by different infectious and non-infectious triggers. It is a major cause of sudden cardiac death, with also long-term adverse outcomes in survivors. The incidence and predictive factors of recurrent AM (RAM) are unknown.

Arrhythmogenic cardiomyopathy (ACM) is a genetically-determined or acquired arrhythmogenic disorder of the myocardium. With an incidence of 1/5000, genetic ACM is the consequence of pathogenic variants in genes encoding for desmosomal and cytoskeleton proteins. Originally described as a right ventricular disease (ARVC), genetic ACM is increasingly recognized as a left (ALVC) or biventricular entity. Genetic ACM may manifest with various clinical presentations, with a predisposition to acute and chronic heart failure, ventricular arrhythmias and sudden cardiac death. Pathophysiology of genetic ACM at early stages remain widely elusive.

Myocardial inflammation has been consistently reported in patients with genetic ACM, but the exact nature of their association is a matter of debate. The temporal association between RAM episodes and the later diagnosis of genetic ACM is speculative, and it has been hypothesized recently that RAM episodes might reflect early active phases in the development of a genetic ACM.

The investigators aim to study the temporal association between RAM episodes and the later diagnosis of an ACM.

Consecutive patients with at least two episodes of AM and referred to a tertiary university referral center (pop. 1.500.000 inhabitants) for clinical expertise, follow-up and etiological work-out were prospectively included in this registry.

Keywords
Recurrent acute myocarditis, Myocardial inflammation, Arrhythmogenic cardiomyopathy
Medical subject headings
Myocarditis, Cardiomyopathies

What is being measured

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

  1. Sustained ventricular arrhythmia

    Any ventricular arrhythmia (VT/VF) :

    • sustained (lasting more than 30 seconds)
    • symptomatic or not (including sudden cardiac arrest)
    • induced or not (including during stress ECG, pharmacological challenge or electrophysiological study)

    Measured: 0 - 1 year after last acute myocarditis episode

  2. Genetic mutation

    Any genetic mutation (cardiomyopathy panel)

    Measured: 0 - 1 year after last acute myocarditis episode

Secondary outcomes (2)

  1. Myocardial substrate characterization

    Cardiac magnetic resonance imaging (left and right ventricular ejection fractions, volumes, late gadolinium enhancement)

    Measured: 0 - 1 year after last acute myocarditis episode

  2. Nonsustained ventricular arrhythmia

    Any ventricular arrhythmia (VT/VF) :

    • nonsustained (lasting less than 30 seconds)
    • symptomatic or not
    • induced or not (including during stress ECG, pharmacological challenge or electrophysiological study)

    Measured: 0 - 1 year after last acute myocarditis episode

Timeline

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

  1. First posted19 Oct 2020
  2. Study start1 Jan 2018
  3. Primary completion1 Jan 2022 (estimated)
  4. Study completion1 Jan 2022 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
20 participants (estimated)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04589156
Sponsor's protocol ID
Rythmo20200818
Acronym
RAM
Status last verified
Oct 2020
First submitted
31 Aug 2020
Last updated
19 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Burke AP, Farb A, Tashko G, Virmani R. Arrhythmogenic right ventricular cardiomyopathy and fatty replacement of the right ventricular myocardium: are they different diseases? Circulation. 1998 Apr 28;97(16):1571-80. doi: 10.1161/01.cir.97.16.1571.

    PubMed 9593562

  • Bauce B, Basso C, Rampazzo A, Beffagna G, Daliento L, Frigo G, Malacrida S, Settimo L, Danieli G, Thiene G, Nava A. Clinical profile of four families with arrhythmogenic right ventricular cardiomyopathy caused by dominant desmoplakin mutations. Eur Heart J. 2005 Aug;26(16):1666-75. doi: 10.1093/eurheartj/ehi341. Epub 2005 Jun 7.

    PubMed 15941723

  • Bowles NE, Ni J, Marcus F, Towbin JA. The detection of cardiotropic viruses in the myocardium of patients with arrhythmogenic right ventricular dysplasia/cardiomyopathy. J Am Coll Cardiol. 2002 Mar 6;39(5):892-5. doi: 10.1016/s0735-1097(02)01688-1.

    PubMed 11869858

  • Chimenti C, Pieroni M, Maseri A, Frustaci A. Histologic findings in patients with clinical and instrumental diagnosis of sporadic arrhythmogenic right ventricular dysplasia. J Am Coll Cardiol. 2004 Jun 16;43(12):2305-13. doi: 10.1016/j.jacc.2003.12.056.

    PubMed 15193698

  • Asimaki A, Tandri H, Duffy ER, Winterfield JR, Mackey-Bojack S, Picken MM, Cooper LT, Wilber DJ, Marcus FI, Basso C, Thiene G, Tsatsopoulou A, Protonotarios N, Stevenson WG, McKenna WJ, Gautam S, Remick DG, Calkins H, Saffitz JE. Altered desmosomal proteins in granulomatous myocarditis and potential pathogenic links to arrhythmogenic right ventricular cardiomyopathy. Circ Arrhythm Electrophysiol. 2011 Oct;4(5):743-52. doi: 10.1161/CIRCEP.111.964890. Epub 2011 Aug 22.

    PubMed 21859801

  • Tanawuttiwat T, Sager SJ, Hare JM, Myerburg RJ. Myocarditis and ARVC/D: variants or mimics? Heart Rhythm. 2013 Oct;10(10):1544-8. doi: 10.1016/j.hrthm.2013.06.008. Epub 2013 Jun 14. No abstract available.

    PubMed 23773988

  • Protonotarios A, Wicks E, Ashworth M, Stephenson E, Guttmann O, Savvatis K, Sekhri N, Mohiddin SA, Syrris P, Menezes L, Elliott P. Prevalence of 18F-fluorodeoxyglucose positron emission tomography abnormalities in patients with arrhythmogenic right ventricular cardiomyopathy. Int J Cardiol. 2019 Jun 1;284:99-104. doi: 10.1016/j.ijcard.2018.10.083. Epub 2018 Oct 26.

    PubMed 30409737

  • Lopez-Ayala JM, Pastor-Quirante F, Gonzalez-Carrillo J, Lopez-Cuenca D, Sanchez-Munoz JJ, Oliva-Sandoval MJ, Gimeno JR. Genetics of myocarditis in arrhythmogenic right ventricular dysplasia. Heart Rhythm. 2015 Apr;12(4):766-73. doi: 10.1016/j.hrthm.2015.01.001. Epub 2015 Jan 20.

    PubMed 25616123

  • Martins D, Ovaert C, Khraiche D, Boddaert N, Bonnet D, Raimondi F. Myocardial inflammation detected by cardiac MRI in Arrhythmogenic right ventricular cardiomyopathy: A paediatric case series. Int J Cardiol. 2018 Nov 15;271:81-86. doi: 10.1016/j.ijcard.2018.05.116. Epub 2018 May 31.

    PubMed 29885824

  • Brown EE, McMilllan KN, Halushka MK, Ravekes WJ, Knight M, Crosson JE, Judge DP, Murphy AM. Genetic aetiologies should be considered in paediatric cases of acute heart failure presumed to be myocarditis. Cardiol Young. 2019 Jul;29(7):917-921. doi: 10.1017/S1047951119001124. Epub 2019 Jun 14.

    PubMed 31198128

  • Ader F, Surget E, Charron P, Redheuil A, Zouaghi A, Maltret A, Marijon E, Denjoy I, Hermida A, Fressart V, Gandjbakhch E. Inherited Cardiomyopathies Revealed by Clinically Suspected Myocarditis: Highlights From Genetic Testing. Circ Genom Precis Med. 2020 Aug;13(4):e002744. doi: 10.1161/CIRCGEN.119.002744. Epub 2020 Jun 10. No abstract available.

    PubMed 32522011

  • Piriou N, Marteau L, Kyndt F, Serfaty JM, Toquet C, Le Gloan L, Warin-Fresse K, Guijarro D, Le Tourneau T, Conan E, Thollet A, Probst V, Trochu JN. Familial screening in case of acute myocarditis reveals inherited arrhythmogenic left ventricular cardiomyopathies. ESC Heart Fail. 2020 Aug;7(4):1520-1533. doi: 10.1002/ehf2.12686. Epub 2020 May 1.

    PubMed 32356610

  • Caforio ALP, Re F, Avella A, Marcolongo R, Baratta P, Seguso M, Gallo N, Plebani M, Izquierdo-Bajo A, Cheng CY, Syrris P, Elliott PM, d'Amati G, Thiene G, Basso C, Gregori D, Iliceto S, Zachara E. Evidence From Family Studies for Autoimmunity in Arrhythmogenic Right Ventricular Cardiomyopathy: Associations of Circulating Anti-Heart and Anti-Intercalated Disk Autoantibodies With Disease Severity and Family History. Circulation. 2020 Apr 14;141(15):1238-1248. doi: 10.1161/CIRCULATIONAHA.119.043931. Epub 2020 Mar 2.

    PubMed 32114801

  • Belkaya S, Kontorovich AR, Byun M, Mulero-Navarro S, Bajolle F, Cobat A, Josowitz R, Itan Y, Quint R, Lorenzo L, Boucherit S, Stoven C, Di Filippo S, Abel L, Zhang SY, Bonnet D, Gelb BD, Casanova JL. Autosomal Recessive Cardiomyopathy Presenting as Acute Myocarditis. J Am Coll Cardiol. 2017 Apr 4;69(13):1653-1665. doi: 10.1016/j.jacc.2017.01.043.

    PubMed 28359509

  • Peretto G, Sala S, Rizzo S, Palmisano A, Esposito A, De Cobelli F, Campochiaro C, De Luca G, Foppoli L, Dagna L, Thiene G, Basso C, Della Bella P. Ventricular Arrhythmias in Myocarditis: Characterization and Relationships With Myocardial Inflammation. J Am Coll Cardiol. 2020 Mar 10;75(9):1046-1057. doi: 10.1016/j.jacc.2020.01.036.

    PubMed 32138965

Questions about this trial

What is this clinical trial studying?

An observational study of Myocarditis and Cardiomyopathy, run by University Hospital, Caen at 1 site in France.

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

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Results are not available in the source record.

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

Contact Pierre Ollitrault, MD, MSc (0231064418, ollitrault-p@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sustained ventricular arrhythmia (time frame: 0 - 1 year after last acute myocarditis episode). The study lists 2 primary outcomes in all. 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 NCT04589156, which also lists 16 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 19 Oct 2020.

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