Last reviewed · How we verify
NCT04294771: JOCARDITE
JOint Use of Database to Identify Risk Factors of CARDio-vascular Toxicity Induced by Immune Checkpoint Inhibitors
trial testing ICI in Myocarditis in 500,000 participants. Status unknown.
1 January 2025
Quick facts
| Lead sponsor | Groupe Hospitalier Pitie-Salpetriere |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 500,000 |
| Start date | 1 January 2019 |
| Primary completion | 1 January 2025 |
| Estimated completion | 1 January 2025 |
| Sites | 1 location across France |
Drugs / interventions tested
- ICI — full drug profile →
Conditions studied
- Myocarditis — all drugs for Myocarditis →
- Cardiomyopathies — all drugs for Cardiomyopathies →
- Heart Diseases — all drugs for Heart Diseases →
- Cardiovascular Diseases — all drugs for Cardiovascular Diseases →
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):
-
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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:
- PubMed search for NCT04294771
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Myocarditis
Currently open trials in the same condition.
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- NCT06730607 — Image-Based Prediction of Ventricular Tachycardias in Post-Myocarditis Patients: an International Multicenter Case-contr · recruiting
- NCT06566209 — FDG-PET as an Imaging Modality to Diagnose and Risk Stratify Subclinical, Imaging Negative Ici-Myocarditis · recruiting
- NCT07086144 — Efficacy of a Myocardial Panel in the Management and Treatment of Pediatric Myocarditis · NA · recruiting
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Other Groupe Hospitalier Pitie-Salpetriere trials
Trials by the same sponsor.
- NCT06515678 — Impact of Antihypertensive Therapy on Recurrence Risk of Ovarian Cancer for Bevacizumab-associated Hypertension · active not recruiting
- NCT05934214 — EXploring Immune-related Adverse Events of Immune checkpoinT Inhibitors Using VigiBase, the WHO Pharmacovigilance Databa · completed
- NCT05819736 — Pharmacokinetics Study Of Rivaroxaban and Apixaban in Cancer Patients · unknown
- NCT04320017 — Joint Use of Electrocardiogram and Transthoracic Echocardiography With Other Clinico-biological Parameters in an Observa · completed
- NCT04314817 — Adverse Events Related to Treatments Used Against Coronavirus Disease 2019 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04294771 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Groupe Hospitalier Pitie-Salpetriere
- Last refreshed: 15 September 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04294771.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing