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NCT Number: NCT07157670

Cardiovascular Complications in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation.

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 15 years
  • Informed about the study and without objection to participation (or with consent from legal guardians)
  • Undergoing allogeneic HSCT

Exclusion criteria

  • Patient not followed up at the participating center
  • Pregnant or breastfeeding women
  • Patient not affiliated with social security
  • Patient under guardianship, curatorship, or legal protection

Treatment and study plan

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Trecy Dr Gonçalves, Dr

CONTACT

[email protected]

+33142499162

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Fédération Française de Cardiologie
  • INSERM U1086 Cancers et Préventions
  • INSERM UMR-S 942 MASCOT

Registry information

Acronym: ALLOCARDIOTOX

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Sep 5, 2025
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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