NCT06350994Recruiting
Early Assessment of Cardiac Function After Treatment With CAR-T Cells
Source: ClinicalTrials.gov · Last updated 2 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 60 (estimated)
- First submitted
- 21 Feb 2024
- Start date
- 7 Nov 2024
- Primary completion date
- Dec 2026
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- NCT number
- NCT06350994
What you commit to
- Study type: Observational
- Planned participants: 60
- From 7 Nov 2024 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Opposition or consent withdrawal
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Critical care medicine department Coordinator of this site? Confirm its status | Paris | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.