Monitoring Drug-induced Myocarditis (CardiTOX)

Sponsor

Groupe Hospitalier Pitie-Salpetriere (Other)

Overall Status

Unknown status

CT.gov ID

NCT03855982

Collaborator

(none)

6,000

Enrollment

Location

10.6

Anticipated Duration (Months)

567.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Myocarditis Myocardial Failure Myocardial Dysfunction	Drug: Drug inducing myocarditis

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

6000 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

Monitoring Drug-induced Myocarditis

Actual Study Start Date :

Apr 9, 2019

Anticipated Primary Completion Date :

Feb 25, 2020

Anticipated Study Completion Date :

Feb 25, 2020

Arms and Interventions

Arm	Intervention/Treatment
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: Drug inducing myocarditis Drugs susceptible to induce myocarditis

Arm

Intervention/Treatment

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: Drug inducing myocarditis

Drugs susceptible to induce myocarditis

Outcome Measures

Primary Outcome Measures

Number of myocarditis induced by drugs and report of cases of myocarditis associated with drugs. [Case reported in the World Health Organization (WHO) database of individual safety case reports to 25/02/2019]

Secondary Outcome Measures

Causality assessment of reported myocarditis events according to the WHO system [Case reported in the World Health Organization (WHO) database of individual safety case reports to 25/02/2019]
Description of the myocarditis depending on the category of drug [Case reported in the World Health Organization (WHO) database of individual safety case reports to 25/02/2019]
Description of the other related adverse events concomitant to the myocarditis induced by drugs [Case reported in the World Health Organization (WHO) database of individual safety case reports to 25/02/2019]
Description of the duration of treatment when the toxicity happens (role of cumulative dose) [Case reported in the World Health Organization (WHO) database of individual safety case reports to 25/02/2019]
Description of the drug-drug interactions associated with adverse events [Case reported in the World Health Organization (WHO) database of individual safety case reports to 25/02/2019]
Description of the population of patients having myocarditis adverse event [Case reported in the World Health Organization (WHO) database of individual safety case reports to 25/02/2019]
Description of the pathologies (cancer) for which the incriminated drugs have been prescribed [Case reported in the World Health Organization (WHO) database of individual safety case reports to 25/02/2019]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM	Paris		France	75013

Sponsors and Collaborators

Groupe Hospitalier Pitie-Salpetriere

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Joe Elie Salem, Assistant director, clinical investigation center Paris Est, Groupe Hospitalier Pitie-Salpetriere

ClinicalTrials.gov Identifier:

NCT03855982

Other Study ID Numbers:

CIC1421-19-03

First Posted:

Feb 27, 2019

Last Update Posted:

Sep 4, 2019

Last Verified:

Sep 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Joe Elie Salem, Assistant director, clinical investigation center Paris Est, Groupe Hospitalier Pitie-Salpetriere

myocardial toxicity

chemotherapies

drugs

Additional relevant MeSH terms:

Myocarditis

Heart Failure

Study Results

No Results Posted as of Sep 4, 2019