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Heart and blood vessel problems linked to immune checkpoint inhibitor cancer drugs

Looks at heart problems, including myocarditis, in people treated with immune checkpoint inhibitors.

Key facts

Who runs it
Groupe Hospitalier Pitie-Salpetriere
Where
Paris, FranceSee the site
Trial code
Registry title
JOint Use of Database to Identify Risk Factors of CARDio-vascular Toxicity Induced by Immune Checkpoint Inhibitors
Status
Recruiting
People taking part
500,000 people, planned
Started
1 Jan 2019
Expected to end
1 Jan 2030
Type of study
Observational, 2 groups
Treatments tested
  • ICI
Record updated
11 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

This study looks back at existing database records, not new volunteers. It studies heart and blood vessel problems in people treated with immune checkpoint inhibitors (ICIs), a type of cancer immunotherapy.

Sex
All sexes.
Disease stage
Cases with a heart or blood vessel side effect reported up to 01/01/2025, such as myocarditis (heart muscle inflammation), heart failure, irregular heartbeat or sudden death. A comparison group includes people treated with ICIs who had no such problems.
Earlier treatment
People must have been treated with an ICI: Ipilimumab, Nivolumab, Pembrolizumab, Durvalumab, Avelumab, Atezolizumab or Cemiplimab.

Main reasons for not taking part

  • The timing between the drug and the heart or blood vessel problem does not fit a link between them.

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

  • 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)

Who cannot take part

  • Chronology not compatible between the drug and the toxicity

Where in France

  • AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM.Paris, FranceContact: Joe-Elie SALEM, MD-PhDTaking people

About the trial

What the trial wants to find out

Immune checkpoint inhibitors (ICIs) might induce high grade immune-related adverse events (irAEs) involving the cardio-vascular system. This study investigates reports of cardio-vascular toxicity associated with treatment including anti-PD1, Anti-PDL-1, and Anti CTLA4 classes using the World Health Organization (WHO) database VigiBase, Assistance Publique Hopitaux de Paris Entrepot de Données de Santé (APHP.EDS), French Système National Des Données de Santé (SNDS) Databases and a retrospective international multicenter registry of ICI-associated myocarditis

The 2 groups in the trial

  • Myocarditis and other cardiovascular toxicities ICI-related

    Case reported in the World Health Organization (WHO)international pharmacovigilance database, or APHP Entrepot de Données de Santé (EDS) and French Système National Des Données de Santé (SNDS) Databases, with a chronology compatible with the drug toxicity

    Treatment: ICI

  • Non case

    Non-case will be patients exposed to ICI without cardiovascular toxicities

    Treatment: ICI

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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
Plain-language title
Heart and blood vessel problems linked to immune checkpoint inhibitor cancer drugsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
11 September 2026