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MyocarditisAMPHIBIANCT04844151

Acute Myocarditis Registry With Prognostic, Histologic, Immunologic, Biological, Imaging and Clinical Assessment

An observational study of Myocarditis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The AMPHIBIA study is an observational ambispective and prospective cohort that aim to describe the histologic, immunologic, biological, imaging, genetic and clinical characteristics of the patients hospitalized for an acute myocarditis and to evaluate their association with prognosis. Read more about this study

Who is it for?
Ages 15 years and older
Conditions the study is for
Myocarditis
How many people
1,400 participants
Where
1 siteFrance
Study dates
23 Jan 2022to 1 May 2041
How long will I take part?
20 Years
Phase
Observational
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 15 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients hospitalised at Pitié-Salpêtrière hospital (Paris, France) for an acute myocarditis.

Who may be able to join

  • Acute myocarditis confirmed by cardiac magnetic resonance according to Lake Louise modified criteria or by endomyocardial biopsy according to histologic, immunologic and immunohistochemic criteria.
  • affiliation to the French Health Care System "Sécurité sociale"

Who cannot join

  • Severe valvulopathy
  • Complex congenital cardiopathy
  • Previous heart transplant
  • Known significative coronary disease

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mathieu Kerneis, MD contact

+33142163001

mathieu.kerneis@aphp.fr

France1 site, 1 recruiting

  • Hôpital Pitié-Salpêtrière

    Paris, 75013

    Mathieu KERNEIS, MD, 0142163001, mathieu.kerneis@aphp.fr

    Recruiting

Other trials in France

About this study

The AMPHIBIA study is an observational ambispective and prospective cohort that aim to describe the histologic, immunologic, biological, imaging, genetic and clinical characteristics of the patients hospitalized for an acute myocarditis and to evaluate their association with prognosis.

Read the detailed description

Acute myocarditis is an inflammatory disease of the heart muscle. Its clinical presentation and its etiologies are multiple and make it a complex disease to treat. Its course also varies, ranging from complete clinical recovery to recurrence of ventricular arrhythmia or progression to chronic dilated heart disease, while being difficult to predict. The long-term prognosis is poorly understood.

Consecutive patients hospitalized in a tertiary university referral center cohort from 2006 to 2041 for an acute myocarditis will be ambispectively or prospectively analyzed. This project will establish a registry including up to 400 patients in the ambispective analysis cohort from 2006 to 2021 and 1000 patients in the prospective analysis cohort during a 20 years inclusion period.

The aim of the study is to describe the characteristics of patients hospitalized for an acute myocarditis and to evaluate their association wih the long term (until 20 years) prognosis.

Features of interest will include :

  • Clinical
  • Biological
  • Etiological
  • Echocardiographic
  • Cardiac magnetic resonance imaging
  • Genetics (for the prospective cohort)
  • Anatomopathological

The collection of clinical, biological and radiological data will represent an unique source allowing research teams in the coming years to access the data necessary to answer various specific questions (pathophysiological, diagnostic, prognostic) relevant to the state of knowledge on this pathology.

Conditions
Myocarditis
Keywords
Cardiomyopathies, Inflammatory heart disease, Magnetic resonance imaging, Viral
Medical subject headings
Myocarditis, Cardiomyopathies

What participants receive

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

Study groups in NCT04844151
Study groupRoleWhat they receive
Acute myocarditisPatients hospitalized for an acute myocarditis.

What is being measured

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

  1. Major cardiac events

    Defined as a composite of :

    • All cause death
    • Resuscitated cardiac arrest
    • Heart transplant
    • Longterm mechanical circulatory support
    • Ventricular arrhythmia after discharge
    • Hospitalization for heart failure
    • Hospitalization for myocarditis recurrence

    Measured: up to 1 years

Secondary outcomes (15)

  1. Major cardiac events

    Defined as a composite of :

    • All cause death
    • Resuscitated cardiac arrest
    • Heart transplant
    • Longterm mechanical circulatory support
    • Ventricular arrhythmia after discharge
    • Hospitalization for heart failure
    • Hospitalization for myocarditis recurrence

    Measured: up to 20 years

  2. All cause death

    Measured: up to 20 years

  3. Cardiovascular death

    Measured: up to 20 years

  4. Heart transplant

    Number of patients with heart transplant

    Measured: up to 20 years

  5. Sustained ventricular arrhythmia after discharge

    Number of patients with sustained ventricular arrhythmia after discharge

    Measured: up to 20 years

  6. Resuscitated cardiac arrest

    Number of patients with resuscitated cardiac arrest

    Measured: up to 20 years

  7. Longterm mechanical circulatory support

    Number of patients implanted with a longterm mechanical circulatory support

    Measured: up to 20 years

  8. Hospitalization for myocarditis recurrence

    Number of patients hospitalized for myocarditis recurrence

    Measured: up to 20 years

  9. Hospitalization for heart failure

    Number of patients with hospitalization for heart failure

    Measured: up to 20 years

  10. Pericardial drainage

    Number of patients with a surgery of pericardial drainage

    Measured: up to 20 years

  11. Supra ventricular arrythmia

    Number of patients with a new onset of supra ventricular arrhythmia

    Measured: up to 20 years

  12. High grade atrioventricular block

    Number of patients with a new high grade atrioventricular block

    Measured: up to 20 years

  13. Pericarditis

    Number of patients with pericarditis diagnosed by the patient referring physician's

    Measured: up to 20 years

  14. Left ventricular systolic function under 50%

    Evaluated by transthoracic echocardiography

    Measured: up to 20 years

  15. Therapeutics during hospital stay

    Type and duration of therapeutics received during the initial hospital stay

    Measured: From the day of admission up to 90 days

Timeline

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

  1. First posted14 Apr 2021
  2. Study start23 Jan 2022
  3. Primary completion1 May 2041 (estimated)
  4. Study completion1 May 2041 (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
Other
Enrolment
1,400 participants (estimated)
Target duration
20 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04844151
Sponsor's protocol ID
APHP201197
Acronym
AMPHIBIA
Status last verified
Jun 2025
First submitted
24 Feb 2021
Last updated
6 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Global Burden of Disease Study 2013 Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 301 acute and chronic diseases and injuries in 188 countries, 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2015 Aug 22;386(9995):743-800. doi: 10.1016/S0140-6736(15)60692-4. Epub 2015 Jun 7.

    PubMed 26063472

  • Corrado D, Basso C, Thiene G. Sudden cardiac death in young people with apparently normal heart. Cardiovasc Res. 2001 May;50(2):399-408. doi: 10.1016/s0008-6363(01)00254-1.

    PubMed 11334844

  • Harmon KG, Drezner JA, Maleszewski JJ, Lopez-Anderson M, Owens D, Prutkin JM, Asif IM, Klossner D, Ackerman MJ. Pathogeneses of sudden cardiac death in national collegiate athletic association athletes. Circ Arrhythm Electrophysiol. 2014 Apr;7(2):198-204. doi: 10.1161/CIRCEP.113.001376. Epub 2014 Mar 1.

    PubMed 24585715

  • Towbin JA, Lowe AM, Colan SD, Sleeper LA, Orav EJ, Clunie S, Messere J, Cox GF, Lurie PR, Hsu D, Canter C, Wilkinson JD, Lipshultz SE. Incidence, causes, and outcomes of dilated cardiomyopathy in children. JAMA. 2006 Oct 18;296(15):1867-76. doi: 10.1001/jama.296.15.1867.

    PubMed 17047217

  • Kuhl U, Pauschinger M, Noutsias M, Seeberg B, Bock T, Lassner D, Poller W, Kandolf R, Schultheiss HP. High prevalence of viral genomes and multiple viral infections in the myocardium of adults with "idiopathic" left ventricular dysfunction. Circulation. 2005 Feb 22;111(7):887-93. doi: 10.1161/01.CIR.0000155616.07901.35. Epub 2005 Feb 7.

    PubMed 15699250

  • Klingel K, Hohenadl C, Canu A, Albrecht M, Seemann M, Mall G, Kandolf R. Ongoing enterovirus-induced myocarditis is associated with persistent heart muscle infection: quantitative analysis of virus replication, tissue damage, and inflammation. Proc Natl Acad Sci U S A. 1992 Jan 1;89(1):314-8. doi: 10.1073/pnas.89.1.314.

    PubMed 1309611

  • Chow LH, Beisel KW, McManus BM. Enteroviral infection of mice with severe combined immunodeficiency. Evidence for direct viral pathogenesis of myocardial injury. Lab Invest. 1992 Jan;66(1):24-31.

    PubMed 1309927

  • Caforio AL, Calabrese F, Angelini A, Tona F, Vinci A, Bottaro S, Ramondo A, Carturan E, Iliceto S, Thiene G, Daliento L. A prospective study of biopsy-proven myocarditis: prognostic relevance of clinical and aetiopathogenetic features at diagnosis. Eur Heart J. 2007 Jun;28(11):1326-33. doi: 10.1093/eurheartj/ehm076. Epub 2007 May 9.

    PubMed 17493945

  • Leone O, Veinot JP, Angelini A, Baandrup UT, Basso C, Berry G, Bruneval P, Burke M, Butany J, Calabrese F, d'Amati G, Edwards WD, Fallon JT, Fishbein MC, Gallagher PJ, Halushka MK, McManus B, Pucci A, Rodriguez ER, Saffitz JE, Sheppard MN, Steenbergen C, Stone JR, Tan C, Thiene G, van der Wal AC, Winters GL. 2011 consensus statement on endomyocardial biopsy from the Association for European Cardiovascular Pathology and the Society for Cardiovascular Pathology. Cardiovasc Pathol. 2012 Jul-Aug;21(4):245-74. doi: 10.1016/j.carpath.2011.10.001. Epub 2011 Dec 3.

    PubMed 22137237

  • Aretz HT, Billingham ME, Edwards WD, Factor SM, Fallon JT, Fenoglio JJ Jr, Olsen EG, Schoen FJ. Myocarditis. A histopathologic definition and classification. Am J Cardiovasc Pathol. 1987 Jan;1(1):3-14. No abstract available.

    PubMed 3455232

  • 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

  • Anderson L, Pennell D. The role of endomyocardial biopsy in the management of cardiovascular disease: a scientific statement from the American Heart Association, the American College of Cardiology, and the European Society of Cardiology. Eur Heart J. 2008 Jul;29(13):1696; author reply 1696-7. doi: 10.1093/eurheartj/ehn189. Epub 2008 May 2. No abstract available.

    PubMed 18456711

  • 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

  • Ferreira VM, Schulz-Menger J, Holmvang G, Kramer CM, Carbone I, Sechtem U, Kindermann I, Gutberlet M, Cooper LT, Liu P, Friedrich MG. Cardiovascular Magnetic Resonance in Nonischemic Myocardial Inflammation: Expert Recommendations. J Am Coll Cardiol. 2018 Dec 18;72(24):3158-3176. doi: 10.1016/j.jacc.2018.09.072.

    PubMed 30545455

  • Ammirati E, Cipriani M, Moro C, Raineri C, Pini D, Sormani P, Mantovani R, Varrenti M, Pedrotti P, Conca C, Mafrici A, Grosu A, Briguglia D, Guglielmetto S, Perego GB, Colombo S, Caico SI, Giannattasio C, Maestroni A, Carubelli V, Metra M, Lombardi C, Campodonico J, Agostoni P, Peretto G, Scelsi L, Turco A, Di Tano G, Campana C, Belloni A, Morandi F, Mortara A, Ciro A, Senni M, Gavazzi A, Frigerio M, Oliva F, Camici PG; Registro Lombardo delle Miocarditi. Clinical Presentation and Outcome in a Contemporary Cohort of Patients With Acute Myocarditis: Multicenter Lombardy Registry. Circulation. 2018 Sep 11;138(11):1088-1099. doi: 10.1161/CIRCULATIONAHA.118.035319.

    PubMed 29764898

Questions about this trial

What is this clinical trial studying?

An observational study of Myocarditis, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 2 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 6 Jun 2025. 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?

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?

Contact Mathieu Kerneis, MD (+33142163001, mathieu.kerneis@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major cardiac events (time frame: up to 1 years). 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 NCT04844151, which also lists 23 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 Jun 2025.

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