Checking heart function early after CAR-T cell treatment
Studies heart function by ultrasound in adults after CAR-T cell treatment for blood cancers.
Plain-language title generated from the registry record
Registry title: Early Assessment of Cardiac Function After Treatment With CAR-T Cells
Key facts
- Where
- Paris, FranceSee the site
Where in France
- Critical care medicine departmentParis, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Assistance Publique - Hôpitaux de Paris
- Trial code
- NCT06350994
- Record updated
- 2 September 2025
- Original description
CAR-T cells (Chimeric Antigen Receptor) are a new immunotherapy, based on the genetic modification of autologous T lymphocytes. CAR-T cell therapy is not devoid of complications.Read full original descriptionShow less
Early Assessment of Cardiac Function After Treatment With CAR-T Cells
CAR-T cells (Chimeric Antigen Receptor) are a new immunotherapy, based on the genetic modification of autologous T lymphocytes. CAR-T cell therapy is not devoid of complications.
Among the most frequent complications are the risk of infection, cytokine release syndrome (CRS) and neurotoxicity. Nevertheless, some authors have reported serious acute cardiac events in a limited number of patients, often contemporaneous with CRS or sepsis, questioning the imputability of CAR-T cells in this heart disease.
This study aims to estimate the incidence of a possible early cardiotoxicity associated with CAR-T cells.
The main endpoint will be the change in cardiac function (LVEF: left ventricular ejection fraction) assessed by ultrasound between the pre CAR-T assessment and the early post CAR-T ultrasound (D3-D5).
Inclusion: CAR-T cells infusion received within 3 to 5 days before the echocardiography; Pre-therapeutic cardiac assessment (in accordance with the recommendations and standard care protocol in force in the hematology department of Saint-Antoine Hospital): Echocardiography and EKG before conditioning and infusion of CAR -T cells,; Not opposed to participating in research; Patient affiliated to a social security system or beneficiary of the "state medical insurance help" (namely aide médicale d'état).
Exclusion: Opposition or consent withdrawal.