ClinicalTrials.gg
RecruitingNCT04844151AMPHIBIAUpdated Jun 6, 2025

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

An observational study in Myocarditis, sponsored by Assistance Publique - Hôpitaux de Paris. Recruiting at 1 site in France. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2025-06-06.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

From the registry’s dates

  • Started Jan 2022; still recruiting 4 years 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
1,400
Ages
15 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 13 studies in Myocarditis by Assistance Publique - Hôpitaux de Paris — 9 open to participants now, 9 under way, 2 of them phase 3. Myocarditis · Assistance Publique - Hôpitaux de Paris.

Started
2022
with 1 other
Observational
6 of 13
5 open now
Registered
4th of 13
by date

Among the 13 studies in Myocarditis by Assistance Publique - Hôpitaux de Paris, this one is one of 2 that started in 2022, is one of 6 observational ones, and was the 4th registered.

By phase

13 studies; the count open now beside each. This study's row is marked.

Observationalthis study6 · 5 open
Phase 22 · 1 open
Phase 32 · 2 open
No phase1 · 0 open
Other kind1 · 1 open
Phase 2/31 · 0 open

By the year they started

First in 2017; this study’s year is marked. 2 started in 2022.

Size and results

Median enrollment 120 across the 6 interventional studies, 1,400 across the 7 observational. Of the 3 that completed or were terminated, 0 (0%) have results posted.

Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 13 studies in Myocarditis by Assistance Publique - Hôpitaux de Paris, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Myocarditis

Keywords

  • Cardiomyopathies
  • Inflammatory heart disease
  • Magnetic resonance imaging
  • Viral
04

Who can participate

Ages eligible
15 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Severe valvulopathy
  • Complex congenital cardiopathy
  • Previous heart transplant
  • Known significative coronary disease
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
1,400 participants (estimated)
Target follow-up
20 Years
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • Acute myocarditis

    Patients hospitalized for an acute myocarditis.

06

What researchers measure

Primary outcomes

  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

    Time frame: up to 1 years

Secondary outcomes

  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

    Time frame: up to 20 years

  2. All cause death

    Time frame: up to 20 years

  3. Cardiovascular death

    Time frame: up to 20 years

  4. Heart transplant

    Number of patients with heart transplant

    Time frame: up to 20 years

  5. Sustained ventricular arrhythmia after discharge

    Number of patients with sustained ventricular arrhythmia after discharge

    Time frame: up to 20 years

  6. Resuscitated cardiac arrest

    Number of patients with resuscitated cardiac arrest

    Time frame: up to 20 years

  7. Longterm mechanical circulatory support

    Number of patients implanted with a longterm mechanical circulatory support

    Time frame: up to 20 years

  8. Hospitalization for myocarditis recurrence

    Number of patients hospitalized for myocarditis recurrence

    Time frame: up to 20 years

  9. Hospitalization for heart failure

    Number of patients with hospitalization for heart failure

    Time frame: up to 20 years

  10. Pericardial drainage

    Number of patients with a surgery of pericardial drainage

    Time frame: up to 20 years

  11. Supra ventricular arrythmia

    Number of patients with a new onset of supra ventricular arrhythmia

    Time frame: up to 20 years

  12. High grade atrioventricular block

    Number of patients with a new high grade atrioventricular block

    Time frame: up to 20 years

  13. Pericarditis

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

    Time frame: up to 20 years

  14. Left ventricular systolic function under 50%

    Evaluated by transthoracic echocardiography

    Time frame: up to 20 years

  15. Therapeutics during hospital stay

    Type and duration of therapeutics received during the initial hospital stay

    Time frame: From the day of admission up to 90 days

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 ↗
  • Bock CT, Klingel K, Kandolf R. Human parvovirus B19-associated myocarditis. N Engl J Med. 2010 Apr 1;362(13):1248-9. doi: 10.1056/NEJMc0911362. No abstract available. PubMed 20357294 ↗
  • 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 ↗
  • Grun S, Schumm J, Greulich S, Wagner A, Schneider S, Bruder O, Kispert EM, Hill S, Ong P, Klingel K, Kandolf R, Sechtem U, Mahrholdt H. Long-term follow-up of biopsy-proven viral myocarditis: predictors of mortality and incomplete recovery. J Am Coll Cardiol. 2012 May 1;59(18):1604-15. doi: 10.1016/j.jacc.2012.01.007. Epub 2012 Feb 22. PubMed 22365425 ↗
  • Aquaro GD, Perfetti M, Camastra G, Monti L, Dellegrottaglie S, Moro C, Pepe A, Todiere G, Lanzillo C, Scatteia A, Di Roma M, Pontone G, Perazzolo Marra M, Barison A, Di Bella G; Cardiac Magnetic Resonance Working Group of the Italian Society of Cardiology. Cardiac MR With Late Gadolinium Enhancement in Acute Myocarditis With Preserved Systolic Function: ITAMY Study. J Am Coll Cardiol. 2017 Oct 17;70(16):1977-1987. doi: 10.1016/j.jacc.2017.08.044. PubMed 29025554 ↗
  • Aquaro GD, Ghebru Habtemicael Y, Camastra G, Monti L, Dellegrottaglie S, Moro C, Lanzillo C, Scatteia A, Di Roma M, Pontone G, Perazzolo Marra M, Barison A, Di Bella G; "Cardiac Magnetic Resonance" Working Group of the Italian Society of Cardiology. Prognostic Value of Repeating Cardiac Magnetic Resonance in Patients With Acute Myocarditis. J Am Coll Cardiol. 2019 Nov 19;74(20):2439-2448. doi: 10.1016/j.jacc.2019.08.1061. PubMed 31727281 ↗
  • Grani C, Biere L, Eichhorn C, Kaneko K, Agarwal V, Aghayev A, Steigner M, Blankstein R, Jerosch-Herold M, Kwong RY. Incremental value of extracellular volume assessment by cardiovascular magnetic resonance imaging in risk stratifying patients with suspected myocarditis. Int J Cardiovasc Imaging. 2019 Jun;35(6):1067-1078. doi: 10.1007/s10554-019-01552-6. Epub 2019 Feb 12. PubMed 30756221 ↗
  • Li HS, Ligons DL, Rose NR. Genetic complexity of autoimmune myocarditis. Autoimmun Rev. 2008 Jan;7(3):168-73. doi: 10.1016/j.autrev.2007.11.010. Epub 2007 Dec 3. PubMed 18190873 ↗
  • Rose NR, Neumann DA, Herskowitz A, Traystman MD, Beisel KW. Genetics of susceptibility to viral myocarditis in mice. Pathol Immunopathol Res. 1988;7(4):266-78. doi: 10.1159/000157122. No abstract available. PubMed 2853345 ↗
  • 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 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04844151
Responsible party
Sponsor
First posted
Apr 14, 2021
Start date
Jan 23, 2022
Primary completion
May 1, 2041 (estimated)
Completion
May 1, 2041 (estimated)
Last update
Jun 6, 2025

Study contacts

Mathieu Kerneis, MD
Contact
mathieu.kerneis@aphp.fr
+33142163001
Giles MONTALESCOT, MD, PhD
study director · ACTION Study Group - Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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