Monitoring Drug-induced Myocarditis (CardiTOX)

Groupe Hospitalier Pitie-Salpetriere

Status: Completed

Conditions: Myocardial Dysfunction; Myocarditis; Myocardial Failure

Treatments: Drug: Drug inducing myocarditis

Study type: Observational

Funder types: Other

Identifiers

NCT03855982

CIC1421-19-03

Details and patient eligibility

About

Several drugs and chemotherapies seem to induce myocarditis. This study investigates reports of myocarditis, including the International classification of disease ICD-10 for treatments in the World Health Organization (WHO) global Individual Case Safety Report (ICSR) database (VigiBase).

Full description

Several drugs and chemotherapies seem to have an impact on the myocardium and are responsible of myocarditis. Those are poorly described, due to the modification of the pharmacopeia, and the recent recognition of several of these adverse events. This study investigates the main characteristics of patients affected by myocarditis side effect imputed to drugs. A causality assessment according to the WHO-UMC (World Health Organization - Uppsala Monitoring Center) is systematically applied.

Enrollment: 6,000 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Case reported in the WHO's pharmacovigilance database till 25/02/2019

Exclusion criteria

• Chronology not compatible between the drug and the toxicity

Trial design

6,000 participants in 1 patient group

myocarditis induced by drugs and chemotherapies

Description:

Case reported in the World Health Organization (WHO) of myocarditis of patient treated by a drug, with a chronology compatible with the drug toxicity

Treatment:

Drug: Drug inducing myocarditis