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

June 3, 2025 updated by: Assistance Publique - Hôpitaux de Paris
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Paris, France, 75013
        • Recruiting
        • Hôpital Pitié-Salpêtrière
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Acute myocarditis
Patients hospitalized for an acute myocarditis.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
up to 1 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
up to 20 years
All cause death
Time Frame: up to 20 years
up to 20 years
Cardiovascular death
Time Frame: up to 20 years
up to 20 years
Heart transplant
Time Frame: up to 20 years
Number of patients with heart transplant
up to 20 years
Sustained ventricular arrhythmia after discharge
Time Frame: up to 20 years
Number of patients with sustained ventricular arrhythmia after discharge
up to 20 years
Resuscitated cardiac arrest
Time Frame: up to 20 years
Number of patients with resuscitated cardiac arrest
up to 20 years
Longterm mechanical circulatory support
Time Frame: up to 20 years
Number of patients implanted with a longterm mechanical circulatory support
up to 20 years
Hospitalization for myocarditis recurrence
Time Frame: up to 20 years
Number of patients hospitalized for myocarditis recurrence
up to 20 years
Hospitalization for heart failure
Time Frame: up to 20 years
Number of patients with hospitalization for heart failure
up to 20 years
Pericardial drainage
Time Frame: up to 20 years
Number of patients with a surgery of pericardial drainage
up to 20 years
Supra ventricular arrythmia
Time Frame: up to 20 years
Number of patients with a new onset of supra ventricular arrhythmia
up to 20 years
High grade atrioventricular block
Time Frame: up to 20 years
Number of patients with a new high grade atrioventricular block
up to 20 years
Pericarditis
Time Frame: up to 20 years
Number of patients with pericarditis diagnosed by the patient referring physician's
up to 20 years
Left ventricular systolic function under 50%
Time Frame: up to 20 years
Evaluated by transthoracic echocardiography
up to 20 years
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
From the day of admission up to 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique - Hôpitaux de Paris

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Giles MONTALESCOT, MD, PhD, ACTION Study Group - Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 23, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2041

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2041

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 24, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 6, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • APHP201197

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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