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

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