Last reviewed · How we verify
NCT03387540: RAFALE
Evaluation of Reporting of Immune Checkpoint Inhibitor Associated Cardio-vascular Adverse Reactions
trial testing ICI in Myocarditis in 104 participants. Completed in 31 December 2017.
4 December 2017
Quick facts
| Lead sponsor | Groupe Hospitalier Pitie-Salpetriere |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 104 |
| Start date | 2 December 2017 |
| Primary completion | 4 December 2017 |
| Estimated completion | 31 December 2017 |
| Sites | 1 location across France |
Drugs / interventions tested
- ICI — full drug profile →
Conditions studied
- Myocarditis — all drugs for Myocarditis →
- Cardiac Complication — all drugs for Cardiac Complication →
Sponsor
Groupe Hospitalier Pitie-Salpetriere
Who can join
18 and older, any sex, with Myocarditis or Cardiac Complication. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Immune checkpoint inhibitors (ICIs) might have high grade immune-related adverse events (irAEs) on the cardio-vascular system. This study investigates reports of cardio-vascular toxicity with treatment including anti-PD1, Anti-PDL-1, and Anti CTLA4 classes using the World Health Organization (WHO) database VigiBase.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Cardiovascular toxicities associated with immune checkpoint inhibitors: an observational, retrospective, pharmacovigilance study.
Salem JE, Manouchehri A, Moey M, Lebrun-Vignes B, et al · · 2018 · cited 934× · PMID 30442497 · DOI 10.1016/s1470-2045(18)30608-9 -
Demographic Factors Associated with Toxicity in Patients Treated with Anti-Programmed Cell Death-1 Therapy.
Shah KP, Song H, Ye F, Moslehi JJ, et al · · 2020 · cited 53× · PMID 32350001 · DOI 10.1158/2326-6066.cir-19-0986
Verify or expand the search:
- PubMed search for NCT03387540
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of ICI
Trials testing the same drug.
- NCT06524570 — Treatment of Cancer With Immune Checkpoint Inhibition Therapy Boosted by High Intensity Focused Ultrasound Histotripsy · Phase 1 · recruiting
- NCT05378334 — Efficacy and Safety of HGXJT in Bone Metastatic NSCLC Patients · NA · recruiting
- NCT04680598 — Comparison of HBV Reactivation Between Patients With High HBV-DNA and Low HBV-DNA Loads Undergoing ICI and Concurrent An · unknown
- NCT04294771 — JOint Use of Database to Identify Risk Factors of CARDio-vascular Toxicity Induced by Immune Checkpoint Inhibitors · unknown
Other recruiting trials for Myocarditis
Currently open trials in the same condition.
- NCT06889662 — GEAM Study Aims At Assessing the Role of Genetic Testing in Patients with Arrhythmic Myocarditis. · recruiting
- 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
- NCT06158698 — CMP-MYTHiC Trial and Registry - CardioMyoPathy With MYocarditis THerapy With Colchicine · Phase 3 · recruiting
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 NCT03387540 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 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: 26 September 2019
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/NCT03387540.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing