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NCT04294771: JOCARDITE

JOint Use of Database to Identify Risk Factors of CARDio-vascular Toxicity Induced by Immune Checkpoint Inhibitors

Status unknown Last updated 15 September 2023
What this trial tests

trial testing ICI in Myocarditis in 500,000 participants. Status unknown.

Timeline
1 January 2019
Primary endpoint
1 January 2025
1 January 2025

Quick facts

Lead sponsorGroupe Hospitalier Pitie-Salpetriere
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment500,000
Start date1 January 2019
Primary completion1 January 2025
Estimated completion1 January 2025
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

Groupe Hospitalier Pitie-Salpetriere

Who can join

Eligibility, any sex, with Myocarditis or Cardiomyopathies. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Cardiomuscular Biomarkers in the Diagnosis and Prognostication of Immune Checkpoint Inhibitor Myocarditis.
    Lehmann LH, Heckmann MB, Bailly G, Finke D, et al · · 2023 · cited 106× · PMID 37317858 · DOI 10.1161/circulationaha.123.062405
  2. Electrocardiographic Manifestations of Immune Checkpoint Inhibitor Myocarditis.
    Power JR, Alexandre J, Choudhary A, Ozbay B, et al · · 2021 · cited 94× · PMID 34723640 · DOI 10.1161/circulationaha.121.055816
  3. Atherosclerosis With Immune Checkpoint Inhibitor Therapy: Evidence, Diagnosis, and Management: <i>JACC: CardioOncology</i> State-of-the-Art Review.
    Suero-Abreu GA, Zanni MV, Neilan TG. · · 2022 · cited 67× · PMID 36636438 · DOI 10.1016/j.jaccao.2022.11.011
  4. Reversal of immune-checkpoint inhibitor fulminant myocarditis using personalized-dose-adjusted abatacept and ruxolitinib: proof of concept.
    Nguyen LS, Bretagne M, Arrondeau J, Zahr N, et al · · 2022 · cited 67× · PMID 35383117 · DOI 10.1136/jitc-2022-004699
  5. Sex-Specific Cardiovascular Risks of Cancer and Its Therapies.
    Wilcox NS, Rotz SJ, Mullen M, Song EJ, et al · · 2022 · cited 60× · PMID 35175846 · DOI 10.1161/circresaha.121.319901
  6. Hormonal therapies up-regulate MANF and overcome female susceptibility to immune checkpoint inhibitor myocarditis.
    Zhang Y, Sun C, Li Y, Qin J, et al · · 2022 · cited 50× · PMID 36322628 · DOI 10.1126/scitranslmed.abo1981
  7. Immune Checkpoint Inhibitor Myocarditis Treatment Strategies and Future Directions.
    Moslehi J, Salem JE. · · 2022 · cited 36× · PMID 36636442 · DOI 10.1016/j.jaccao.2022.11.005
  8. Immune checkpoint inhibitor-associated myocarditis: a novel risk score.
    Power JR, Dolladille C, Ozbay B, Procureur A, et al · · 2026 · cited 25× · PMID 40569849 · DOI 10.1093/eurheartj/ehaf315

Verify or expand the search:

Other trials of ICI

Trials testing the same drug.

Other recruiting trials for Myocarditis

Currently open trials in the same condition.

Other Groupe Hospitalier Pitie-Salpetriere trials

Trials by the same sponsor.

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Data sources for this page

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