NCT03882580

Reporting, Evaluating, Preventing and Treating the Cardiotoxicity Induced by Anticancer Drugs During a Specific Cardio-oncology Consult and Follow up in Routine Care

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 5,000 (estimated)
• Sponsor: Groupe Hospitalier Pitie-Salpetriere · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Several Drugs used in routine care in oncology induce rare but often severe or fatal cardiovascular or metabolic side effects. This study will investigate, evaluate, report and treat the cardiovascular side effects of anticancer drugs, through a specific cardiovascular routine checkup and follow-up taking place in several Cardio-oncology programs throughout France. The different including centers will be: Assistance Publique - Hôpitaux de Paris (APHP.6: Pitié-Salpétrière, Saint Antoine and Tenon's hospitals, Paris, France).

Detailed description

Several anticancer and supportive care drugs used in oncology have an impact on the cardiovascular and metabolic systems, leading to a wide range of cardiovascular and metabolic disorders and side effects. Those are poorly described, due to the evolution of the anticancer pharmacopeia, and recent recognition of these adverse events. This study will investigate the potential benefits of a specialized cardio-oncology check-up and follow-up in this context.

Conditions

• Cardiovascular Complication
• Cardiovascular Insufficiency
• Cardiac Complication
• Oncologic Complications
• Cardiac Insufficiency
• Metabolic Disorder
• Vascular Disorder
• Cardiac Disorder

Interventions

Type	Name	Description
DRUG	Anti-Cancer Agents	Drugs and treatments used in cancer inducing cardiovascular and metabolic side effects

Timeline

• Start date: 2019-03-01
• Primary completion: 2025-03-01
• Completion: 2025-03-01
• First posted: 2019-03-20
• Last updated: 2023-04-24

Locations

3 sites across 1 country: France

Regulatory

• FDA-regulated drug study