Identifying Risk Factors for Heart Toxicity from Immune Checkpoint Inhibitors
JOint Use of Database to Identify Risk Factors of CARDio-vascular Adverse Reactions Induced by Immune Checkpoint InhibiTors: VigiBase, Entrepot de Données de Santé (EDS), Système National Des Données de Santé (SNDS) Databases and a Retrospective International Multicenter Registry of ICI-associated Myocarditis
Groupe Hospitalier Pitie-Salpetriere · NCT04294771
This study is trying to find out what factors might increase the risk of heart problems in people receiving immune checkpoint inhibitors for cancer treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500000 (estimated) |
| Sex | All |
| Sponsor | Groupe Hospitalier Pitie-Salpetriere (other) |
| Drugs / interventions | Ipilimumab, Nivolumab, Pembrolizumab, Durvalumab, Avelumab, Atezolizumab, Cemiplimab |
| Locations | 1 site (Paris) |
| Trial ID | NCT04294771 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study include patients who have experienced cardiovascular adverse events while being treated with immune checkpoint inhibitors.
Not a fit: Patients who have not received immune checkpoint inhibitors or those without reported cardiovascular issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the safety and efficacy of immune checkpoint inhibitors by identifying patients at risk for cardiovascular toxicity.
How similar studies have performed: Other studies have indicated potential risks associated with immune checkpoint inhibitors, but this specific approach of utilizing multiple databases for risk factor identification is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Paris
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Myocarditis, Cardiomyopathies, Heart Diseases, Cardiovascular Diseases, Pericarditis, Vasculitis, Drug-induced cardiotoxicity, Immune Checkpoint Inhibitors