Clinical trial NCT06268535: Identification of Anticancer Drugs Associated With Cancer Therapy-related Cardiac Dysfunction: a Pharmacovigilance Study
Official title: Identification of Anticancer Drugs Associated With Cancer Therapy-related Cardiac Dysfunction: a WHO Pharmacovigilance Database
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Cancer, Therapy-Related
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 36580288
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Every patients in the World Health Organization (WHO) database of individual safety case reports to 29/02/2024 included with at least one anticander drug.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Case reported in the World Health Organization (WHO) database of individual safety case reports to 29/02/2024
* Patients treated with FDA and/or EMA approved cancer therapies (approval the 30th September 2023).

Primary outcomes:
measure: Disproportionality individual case data analysis between heart failure of cardiac dysfunction and cancer therapies
timeFrame: Case reported in the World Health Organization (WHO) of individual safety case reports to March 2024
Secondary outcomes:
measure: Description of the population of patients having a heart failure of cardiac dysfunction event with cancer therapies
timeFrame: Case reported in the World Health Organization (WHO) of individual safety case reports to March 2024
measure: Description of the pathologies (cancer) for which the incriminated drugs have been prescribed
timeFrame: Case reported in the World Health Organization (WHO) of individual safety case reports to March 2024
measure: Description of the drug-drug interactions associated with adverse events
timeFrame: Case reported in the World Health Organization (WHO) of individual safety case reports to March 2024
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen University Hospital
Study officials:
References: