Cardiovascular Complications in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation.

NCT ID: NCT07157670

Last Updated: 2025-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-15

Study Completion Date

2028-09-15

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiotoxicity DPP3 HSCT Allogeneic Hematopoietic Stem Cell Transplantation ACS - Acute Coronary Syndrome Cardiac Dysfunction Arrythmia, Cardiac Pulmonary Hypertension Machine Learning

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort of consecutive HSCT patients.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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INSERM UMR-S 942 MASCOT

UNKNOWN

Sponsor Role collaborator

INSERM U1086 Cancers et Préventions

UNKNOWN

Sponsor Role collaborator

Fédération Française de Cardiologie

OTHER

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Trecy Dr Gonçalves, Dr

Role: CONTACT

+33142499162

Other Identifiers

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N°IDRCB: 2025-A00066-43

Identifier Type: OTHER

Identifier Source: secondary_id

APHP250015

Identifier Type: -

Identifier Source: org_study_id

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