Cardiovascular Complications in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation.
- Sponsor
- Assistance Publique - Hôpitaux de Paris
- Study ID
- NCT07157670
- Status
- Not Yet Recruiting
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Conditions
- ACS - Acute Coronary Syndrome
- Allogeneic Hematopoietic Stem Cell Transplantation
- Arrythmia, Cardiac
- Cardiac Dysfunction
- Cardiotoxicity
- DPP3
- HSCT
- Machine Learning
- Pulmonary Hypertension
Eligibility Criteria
- Sex
- ALL
- Age
- 15 Years - N/A
- Healthy Volunteers
- Not accepted
Study Details
Allogeneic hematopoietic stem cell transplantation (HSCT) represents a major therapeutic strategy for malignant hematologic diseases, with the number of procedures steadily increasing in France each year. Conditioning and maintenance regimens carry a risk of both short- and long-term cardiotoxicity, leading to serious cardiovascular events including acute coronary syndrome (ACS), cardiac dysfunction, arrhythmias, pulmonary hypertension, and pericardial effusion. The pathophysiology of cardiotoxicity in HSCT patients remains poorly understood. It is therefore crucial to investigate underlying mechanisms and identify predictive factors of cardiotoxicity in order to provide appropriate cardiological follow-up and management. Current European Society of Cardiology guidelines recommend routine monitoring of HSCT patients with echocardiography and cardiac biomarkers (NT-proBNP, troponin), although these recommendations are based on small-scale studies. The cardiodepressor factor DPP3 has shown promising results in cardio-oncology, with a causal role in anthracycline-induced cardiac dysfunction. Its role in HSCT-related cardiotoxicity requires further evaluation. This multicenter study of HSCT recipients will be a valuable resource, enabling a better understanding of the pathophysiology of cardiotoxicity and prognosis. It will highlight imaging (echocardiography, calcium score, supra-aortic Doppler), electrocardiographic, and biological markers (including DPP3) associated with prognosis.
Key Dates
- First listed
- Sep 5, 2025
- Start date
- Sep 15, 2025
- Status verified
- Sep 2025
- Primary completion
- Dec 25, 2027
- Completion
- Sep 15, 2028
Study Design
- Enrollment
- 400 participants (estimated)
Arms
- Arm: Cohort of consecutive HSCT patients.
Primary Outcome Measure
Composite cardiotoxicity outcome during follow-up of 1 year, defined as cardiovascular mortality, cardiac dysfunction, acute coronary syndrome, pericarditis, and supraventricular or ventricular arrhythmias. [ Time Frame: During follow-up of 1 year ]
Central Contacts
- Trecy Dr Gonçalves, Dr+33142499162
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