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

NCT04844151 | Recruiting

• 1 other identifier: APHP201197
• Study Type: observational
• Target: 1,400
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocarditis

Keywords

Cardiomyopathies; Inflammatory heart disease; Magnetic resonance imaging; Viral

Outcome Measures

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

  up to 1 years

Secondary Outcomes (15)

• Major cardiac events

  up to 20 years

• All cause death

  up to 20 years

• Cardiovascular death

  up to 20 years

• Heart transplant

  up to 20 years

• Sustained ventricular arrhythmia after discharge

  up to 20 years

Study Arms (1)

Acute myocarditis

Patients hospitalized for an acute myocarditis.

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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"

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Pitié-Salpêtrière

Paris, 75013, France

RECRUITING

Related Publications (23)

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Biospecimen

Retention: SAMPLES WITH DNA

Whole blood 20ml

MeSH Terms

Conditions

Myocarditis; Cardiomyopathies

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Giles MONTALESCOT, MD, PhD

  ACTION Study Group - Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Central Study Contacts

Mathieu Kerneis, MD

CONTACT

+33142163001; mathieu.kerneis@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 20 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2021
• First Posted: April 14, 2021
• Study Start: January 23, 2022
• Primary Completion (Estimated): May 1, 2041
• Study Completion (Estimated): May 1, 2041
• Last Updated: June 6, 2025

Record last verified: 2025-06

Locations

FR (1)