Identification of Anticancer Drugs Associated With Cancer Therapy-related Cardiac Dysfunction: a Pharmacovigilance Study

C

Caen University Hospital

Status

Completed

Conditions

Heart Failure
Cancer, Therapy-Related

Treatments

Drug: Cancer therapy with FDA and/or (European Medicines Agency) EMA approval on the 31st March 2022

Study type

Observational

Funder types

Other

Identifiers

NCT06268535
CaenUH_DL_1

Details and patient eligibility

About

Therapeutic advances have significantly improved the survival of patients with cancer. However, these novel therapies are associated with a concomitant increase in the prevalence of toxicity, including cardiovascular complications of cancer therapy. Among these adverse drug reactions, heart failure and, more generally, cancer therapy-related cardiac dysfunction are the most concerning cardiovascular complications of cancer therapy, carrying a high morbidity burden and an elevated risk of death. Patients with both heart failure and cancer have a worse prognosis when compared with heart failure patients with no history of cancer. It is therefore crucial to enhance the identification of patients at a higher risk of cancer therapy-related cardiac dysfunction both before and during treatment, especially when utilizing cancer therapies with known potential cardiovascular adverse drug reactions. The explosion of new anticancer drugs has led to the potential association of these therapies with cardiac dysfunction. Using VigiBase, the World Health Organization's (WHO) global pharmacovigilance database, the investigators aimed to assess the relationship between cancer therapy-related cardiac dysfunction and the administration of anti-cancer drugs.

Enrollment

3,406,383 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: * Case reported in the World Health Organization (WHO) database of individual safety case reports to 01/04/2022 * Patients treated with FDA and/or EMA approved cancer therapies (approval the 31st March 2023).

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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