Identifying Risk Factors for Heart Toxicity from Immune Checkpoint Inhibitors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study investigates cardiovascular toxicity associated with immune checkpoint inhibitors (ICIs) such as anti-PD-1, anti-PD-L1, and anti-CTLA-4. By utilizing the World Health Organization's VigiBase and French health databases, the study aims to identify risk factors for heart-related adverse events linked to these treatments. The research will analyze reported cases of myocarditis and other cardiovascular issues to better understand the safety profile of ICIs. The findings could help improve patient management and treatment protocols for those receiving ICIs.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Case reported in the World Health Organization (WHO) database of individual safety case reports to 01/01/2025
* Case reported in the APHP Entrepot de Données de Santé (EDS) database of individual safety case reports to 01/01/2025
* Case reported in the Système National Des Données de Santé (SNDS) Database of individual safety case reports to 01/01/2025
* Case reported in a retrospective international multicenter registry of ICI-associated myocarditis to 01/01/2025
* Adverse event reported were including the MedDRA terms: Cardiac and vascular investigations (excl enzyme tests) (HLGT), Vascular disorders (SOC), Skeletal and cardiac muscle analyses (HLT), Sudden death (PT), Sudden cardiac death (PT), Cardiac disorders (SOC), Cardiac arrhythmias (HLGT), Cardiac disorder signs and symptoms (HLGT), Cardiac neoplasms (HLGT), Cardiac valve disorders (HLGT), Congenital cardiac disorders (HLGT), Coronary artery disorders (HLGT), Endocardial disorders (HLGT), Heart failures (HLGT), Myocardial disorders (HLGT), Pericardial disorders (HLGT)
* Patients treated with ICIs included in the ATC: Ipilimumab (L01XC11), Nivolumab (L01XC17), Pembrolizumab (L01XC18), Durvalumab (L01XC28), Avelumab (L01XC31), Atezolizumab (L01XC32), Cemiplimab (L01XC33)

Exclusion Criteria:

* Chronology not compatible between the drug and the toxicity

Where it's running

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

Study contacts

• Study coordinator: Joe-Elie SALEM, MD PhD
• Email: joe-elie.salem@aphp.fr
• Phone: 142178531

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.