Cardiovascular Complications in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation.

NCT07157670 | Not Yet Recruiting

• 2 other identifiers: APHP250015N°IDRCB: 2025-A00066-43
• Study Type: observational
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

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

Keywords

DPP3; HSCT; Cardiotoxicity; Allogeneic hematopoietic stem cell transplantation; Machine Learning

Outcome Measures

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.

  During follow-up of 1 year

Study Arms (1)

Cohort of consecutive HSCT patients.

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All consecutive patients hospitalized for HSCT in the participating centers, meeting eligibility criteria, will be included.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• INSERM UMR-S 942 MASCOT: collaborator
• INSERM U1086 Cancers et Préventions: collaborator
• Fédération Française de Cardiologie: collaborator

Biospecimen

Retention: SAMPLES WITHOUT DNA

Evaluate DPP3 as a predictive biomarker of cardiac dysfunction in a cohort of consecutive HSCT patients.

MeSH Terms

Conditions

Cardiotoxicity; Acute Coronary Syndrome; Arrhythmias, Cardiac; Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries; Myocardial Ischemia; Vascular Diseases; Lung Diseases; Respiratory Tract Diseases; Hypertension

Central Study Contacts

Trecy Dr Gonçalves, Dr

CONTACT

+33142499162; trecy.goncalves@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: September 5, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): December 25, 2027
• Study Completion (Estimated): September 15, 2028
• Last Updated: September 5, 2025

Record last verified: 2025-09