Early heart function check after CAR-T treatment
Official title: Early Assessment of Cardiac Function After Treatment With CAR-T Cells
Run by Assistance Publique - Hôpitaux de Paris · NCT06350994 · Data updated 2026-11-12
We will test whether people treated with CAR‑T cells for blood cancers have early changes in heart function by doing an ultrasound and blood tests 3–5 days after infusion.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Drugs / interventions | CAR-T, Chimeric Antigen Receptor, immunotherapy |
| Locations | 1 site (Paris) |
| Status | Recruiting |
| Started | November 7, 2024 |
| Main results expected | December 2026 |
| Study ends | March 2027 |
| Registry record updated | September 2, 2025 |
| Trial ID | NCT06350994 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients with hematologic malignancies who receive CAR‑T infusion, have a pre‑treatment echocardiogram and ECG, and can undergo bedside echocardiography 3–5 days after infusion.
✕Probably not a fit
Patients who lack a pre‑CAR‑T cardiac assessment, cannot attend the in‑hospital 3–5 day window, decline participation, or are too unstable for bedside imaging are unlikely to benefit from this screening protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study screens patients who receive CAR‑T cell therapy for early cardiac dysfunction using bedside transthoracic echocardiography between days 3 and 5 after infusion. The primary outcome is the change in left ventricular ejection fraction (LVEF) from the pre‑CAR‑T baseline to the early post‑infusion echocardiogram, and routine biomarkers (BNP, troponin) and ECGs are also recorded. Eligible participants are those with a pre‑therapeutic cardiac assessment who receive CAR‑T treatment at the participating center. The aim is to estimate the incidence of early cardiotoxicity and to detect asymptomatic heart dysfunction that may be missed without systematic early screening.
Why it matters
Potential benefit: If successful, this approach could help clinicians detect and treat early CAR‑T–related heart problems sooner, potentially reducing related complications and ICU stays.
How similar studies have gone: Previous reports have documented acute cardiac events after CAR‑T therapy, but systematic early bedside echocardiographic screening is relatively novel and not yet proven to change outcomes.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * Opposition or consent withdrawal
Where it's running
-
Critical care medicine department
Paris, France Recruiting
Study contacts
- Principal investigator: Jérémie JOFFRE — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Jérémie JOFFRE, MD, PhD
- Email: Jeremie.joffre@aphp.fr
- Phone: +33 1 49 28 21 45
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.