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

ConditionMyocarditis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age15+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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"

Disqualifiers

Severe valvulopathy

Complex congenital cardiopathy

Previous heart transplant

Known significative coronary disease

Trial population

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

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

1,400 Participants
are grouped into 1 trial group
Group A: Acute myocarditis

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.