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

Recruiting

• Conditions: Myocarditis

• Registration Number: NCT04844151
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief 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.

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 Timeline

• Study First Submitted: 2021-02-24
• Study First Submitted QC: 2021-04-13
• Study First Posted: 2021-04-14
• Study Start: 2022-01-23
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-23
• Last Update Posted: 2025-01-27
• Primary Completion: 2041-05-01
• Study Completion: 2041-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1400

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major cardiac events	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 Outcome Measures

Name	Time	Method
Heart transplant	up to 20 years	Number of patients with heart transplant
Therapeutics during hospital stay	From the day of admission up to 90 days	Type and duration of therapeutics received during the initial hospital stay
Major cardiac events	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
Resuscitated cardiac arrest	up to 20 years	Number of patients with resuscitated cardiac arrest
Longterm mechanical circulatory support	up to 20 years	Number of patients implanted with a longterm mechanical circulatory support
Supra ventricular arrythmia	up to 20 years	Number of patients with a new onset of supra ventricular arrhythmia
All cause death	up to 20 years
Cardiovascular death	up to 20 years
Sustained ventricular arrhythmia after discharge	up to 20 years	Number of patients with sustained ventricular arrhythmia after discharge
Hospitalization for myocarditis recurrence	up to 20 years	Number of patients hospitalized for myocarditis recurrence
Hospitalization for heart failure	up to 20 years	Number of patients with hospitalization for heart failure
Pericardial drainage	up to 20 years	Number of patients with a surgery of pericardial drainage
Pericarditis	up to 20 years	Number of patients with pericarditis diagnosed by the patient referring physician's
High grade atrioventricular block	up to 20 years	Number of patients with a new high grade atrioventricular block
Left ventricular systolic function under 50%	up to 20 years	Evaluated by transthoracic echocardiography

Trial Locations

Locations (1)

Hôpital Pitié-Salpêtrière; 🇫🇷 Paris, France