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临床试验/NCT07157670
NCT07157670尚未招募不适用

Cardiovascular Complications in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation.

Assistance Publique - Hôpitaux de Paris0 个研究点目标入组 400 人开始时间: 2025年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
400
主要终点
Composite cardiotoxicity outcome during follow-up of 1 year, defined as cardiovascular mortality, cardiac dysfunction, acute coronary syndrome, pericarditis, and supraventricular or ventricular arrhythmias.

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
15 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Composite cardiotoxicity outcome during follow-up of 1 year, defined as cardiovascular mortality, cardiac dysfunction, acute coronary syndrome, pericarditis, and supraventricular or ventricular arrhythmias.

时间窗: During follow-up of 1 year

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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