Trials / Completed
CompletedNCT03855982
Monitoring Drug-induced Myocarditis (CardiTOX)
Monitoring Drug-induced Myocarditis
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 6,000 (actual)
- Sponsor
- Groupe Hospitalier Pitie-Salpetriere · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Drug inducing myocarditis | Drugs susceptible to induce myocarditis |
Timeline
- Start date
- 2019-04-09
- Primary completion
- 2020-02-25
- Completion
- 2023-04-04
- First posted
- 2019-02-27
- Last updated
- 2023-04-05
Locations
1 site across 1 country: France
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03855982. Inclusion in this directory is not an endorsement.