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NCT Number: NCT04844151

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

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.

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Key information

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Pitié-Salpêtrière

Paris, 75013, France

Location status: Recruiting

Location contact

Mathieu KERNEIS, MD

CONTACT

[email protected]

0142163001

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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"

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Major cardiac events

    Time frame: up to 1 years

    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

Secondary outcomes

  1. Major cardiac events

    Time frame: up to 20 years

    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
  2. All cause death

    Time frame: up to 20 years

  3. Cardiovascular death

    Time frame: up to 20 years

  4. Heart transplant

    Time frame: up to 20 years

    Number of patients with heart transplant

  5. Sustained ventricular arrhythmia after discharge

    Time frame: up to 20 years

    Number of patients with sustained ventricular arrhythmia after discharge

  6. Resuscitated cardiac arrest

    Time frame: up to 20 years

    Number of patients with resuscitated cardiac arrest

  7. Longterm mechanical circulatory support

    Time frame: up to 20 years

    Number of patients implanted with a longterm mechanical circulatory support

  8. Hospitalization for myocarditis recurrence

    Time frame: up to 20 years

    Number of patients hospitalized for myocarditis recurrence

  9. Hospitalization for heart failure

    Time frame: up to 20 years

    Number of patients with hospitalization for heart failure

  10. Pericardial drainage

    Time frame: up to 20 years

    Number of patients with a surgery of pericardial drainage

  11. Supra ventricular arrythmia

    Time frame: up to 20 years

    Number of patients with a new onset of supra ventricular arrhythmia

  12. High grade atrioventricular block

    Time frame: up to 20 years

    Number of patients with a new high grade atrioventricular block

  13. Pericarditis

    Time frame: up to 20 years

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

  14. Left ventricular systolic function under 50%

    Time frame: up to 20 years

    Evaluated by transthoracic echocardiography

  15. Therapeutics during hospital stay

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

    Type and duration of therapeutics received during the initial hospital stay

Study contacts

Contact information is provided by the study sponsor or research team.

Mathieu Kerneis, MD

CONTACT

[email protected]

+33142163001

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: AMPHIBIA

Important dates

Study start
2022
Primary completion
2041
Study completion
2041
First posted
Apr 14, 2021
Registry last updated
Jun 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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