Monitoring Drug-induced Myocarditis (CardiTOX) (CardiTOX)

Monitoring Drug-induced Myocarditis

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).

Study Overview

• Status: Completed
• Conditions: Myocarditis; Myocardial Dysfunction; Myocardial Failure
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 6000

Contacts and Locations

• Study Contact: Name: Joe-Elie Salem, Md, PhD; Phone Number: +33 (0)1 42 17 85 35; Email: joe-elie.salem@aphp.fr

Study Locations

• France
  • Paris, France, 75013
    • AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients treated with a drug that could be reported in the WHO's pharmacovigilance database

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Groupe Hospitalier Pitie-Salpetriere

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2019
• Primary Completion (Actual): February 25, 2020
• Study Completion (Actual): April 4, 2023

Study Registration Dates

• First Submitted: February 25, 2019
• First Submitted That Met QC Criteria: February 25, 2019
• First Posted (Actual): February 27, 2019

Study Record Updates

• Last Update Posted (Actual): April 5, 2023
• Last Update Submitted That Met QC Criteria: April 4, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: drugs; myocardial toxicity; chemotherapies
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Cardiomyopathies; Heart Failure; Myocarditis
• Other Study ID Numbers: CIC1421-19-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes