An observational study in Myocarditis and Cardiac Complication, sponsored by Groupe Hospitalier Pitie-Salpetriere. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-26.
Sponsored by Groupe Hospitalier Pitie-Salpetriere · Observational
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 31 studies in Myocarditis with a site in France — 11 open to participants now, 13 under way, 2 of them phase 3. Myocarditis · France.
Among the 31 studies in Myocarditis with a site in France, this one is the 14th largest by enrollment of the 19 observational ones that give a count, is one of 3 that started in 2017, is one of 19 observational ones, and was the 5th registered.
174 studies on the registry are indexed under Myocarditis; 75 are open to participants now.
Browse Myocarditis studies →11 of the 31 studies in Myocarditis with a site in France are open now. Recruiting first, the newest first:
Groupe Hospitalier Pitie-Salpetriere · Sites in France
Assistance Publique - Hôpitaux de Paris · Sites in France
Ages 18+
Assistance Publique - Hôpitaux de Paris · Sites in France
Ages 18+
Assistance Publique - Hôpitaux de Paris · Sites in France
Ages 18–65
Central Hospital, Nancy, France · Sites in France
Ages 18–80
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 53 Myocarditis studies recruiting now, 31 (58%) set no upper age limit and 6 (11%) stop at 75 or younger; 15 take children under 18; 14 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
31 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 3 · Phase 3 3
First in 2016; this study’s year is marked. 3 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 104 is below the median of 208 across 120 observational studies indexed under Myocarditis.
Median enrollment 110 across the 12 interventional studies, 500 across the 19 observational. Of the 15 that completed or were terminated, 1 (7%) have results posted.
This tab as a report to print or save as PDF → With an account.
1 of 31 have an industry lead sponsor. The 10 most frequent:
Groupe Hospitalier Pitie-Salpetriere is the lead sponsor of 66 studies on the registry; 4 are open to participants now.
Groupe Hospitalier Pitie-Salpetriere has 5 studies filed under Myocarditis — fewer than ten, so there is no comparison to draw.
3 of the studies in Myocarditis with a site in France that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07077304Assistance Publique - Hôpitaux de ParisEACVI Study on Multimodality Cardiovascular Imaging of Inflammatory Cardiovascular Diseases | 2027-08-31 |
| NCT07633587Groupe Hospitalier Pitie-SalpetriereATROPOS: Survival Analysis of ICI-associated Myocarditis | 2027-10-01 |
| NCT03842592University Hospital, AngersVentricular Arrhythmia After Myocarditis in Sportsman | 2027-11 |
Add all 3 to your calendar (.ics) → With an account.
Among the 31 studies in Myocarditis with a site in France, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
ICIs have dramatically improved clinical outcomes in multiple cancer types and are increasingly being tested in earlier disease settings and used in combination. However, irAEs can occur. Here the investigators use VigiBase (http://www.vigiaccess.org/), the World Health Organization (WHO) database of individual safety case reports, to identify cases of cardiovascular adverse drug reaction following treatment with ICIs.
Patients treated with an ICI for a cancer
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Case reported in the World Health Organization (WHO) of myocarditis of patient treated by ICI, with a chronology compatible with the drug toxicity
Drug: ICI
Immune checkpoint inhibitor targeting either PD-1, PD-L1 or CTLA-4, and included in the following list (ATC classification): Ipilimumab (L01XC11), Nivolumab (L01XC17), Pembrolizumab (L01XC18), Durvalumab (L01XC28), Avelumab (L01XC31), Atezolizumab (L01XC32).
This study also gives Pembrolizumab, Nivolumab, Ipilimumab, Durvalumab, Atezolizumab. No intervention listed here names it: that was found by reading the record.
Cardio-vascular toxicity of ICIs.
Identification and report of the cardio-vascular toxicity of ICIs. The research includes the report with MedDRA terms: SOC Cardiac Disorders, SOC Vascular Disorders, Sudden death (PT), Cardiac and vascular investigations (excl enzyme tests) (HLGT), Skeletal and cardiac muscle analyses (HLT). Drugs investigated are ICIs: Ipilimumab (L01XC11), Nivolumab (L01XC17), Pembrolizumab (L01XC18), Durvalumab (L01XC28), Avelumab (L01XC31), Atezolizumab (L01XC32).
Time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 12/31/2017
Causality assessment of reported cardiovascular events according to the WHO system
Time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 12/31/2017
Description of the type of cardiotoxicity depending on the category of ICIs
Time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 12/31/2017
Description of the duration of treatment when the toxicity happens (role of cumulative dose)
Time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 12/31/2017
Description of the drug-drug interactions associated with adverse events
Time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 12/31/2017
Description of the pathologies (cancer) for which the incriminated drugs have been prescribed
Time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 12/31/2017
Description of the population of patients having a cardio-vascular adverse event
Time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 12/31/2017
Plan to share: Undecided
Ran from Dec 2017 to primary completion in Dec 2017, 0 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Groupe Hospitalier Pitie-Salpetriere