Monitoring Drug-induced Myocarditis (CardiTOX)

NCT ID: NCT03855982

Last Updated: 2023-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

6000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-09

Study Completion Date

2023-04-04

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Myocarditis Myocardial Failure Myocardial Dysfunction

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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myocarditis induced by drugs and chemotherapies

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

Drug inducing myocarditis

Intervention Type DRUG

Drugs susceptible to induce myocarditis

Interventions

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Drug inducing myocarditis

Drugs susceptible to induce myocarditis

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Groupe Hospitalier Pitie-Salpetriere

OTHER

Sponsor Role lead

Responsible Party

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Joe Elie Salem

Assistant director, clinical investigation center Paris Est

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM

Paris, , France

Site Status

Countries

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France

Other Identifiers

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CIC1421-19-03

Identifier Type: -

Identifier Source: org_study_id

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