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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06268535
• Other study ID #: CaenUH_DL_1
• Status: Completed
• Start date: April 1, 2022
• Est. completion date: May 31, 2022

Study information

• Verified date: November 2023
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3406383
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Cancer, Therapy-Related
• Heart Failure
• Neoplasms, Second Primary

Intervention

Drug:
• Cancer therapy with FDA and/or (European Medicines Agency) EMA approval on the 31st March 2022
Disproportionality analysis studying the association between cancer therapy with FDA and/or EMA approval on the 31st March 2022 and heart failure or cardiac dysfunction in the World Health Organization pharmacovigilance database.

Locations

Country	Name	City	State
France	Caen University Hospital	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disproportionality individual case data analysis between heart failure of cardiac dysfunction and cancer therapies	A disproportionality analysis is carried out in multivariate analysis taking into account confounding factors (factors known to promote heart failure or cardiac dysfunction).	Case reported in the World Health Organization (WHO) of individual safety case reports to September 2023
Secondary	Description of the population of patients having a heart failure of cardiac dysfunction event with cancer therapies	The investigators describe the profile of cases of heart failure of cardiac dysfunction among cancer therapies associated with heart failure or cardiac dysfunction in the main analysis. We particularly focused on factors known to promote heart failure.	Case reported in the World Health Organization (WHO) of individual safety case reports to September 2023
Secondary	Description of the pathologies (cancer) for which the incriminated drugs have been prescribed		Case reported in the World Health Organization (WHO) of individual safety case reports to September 2023
Secondary	Description of the drug-drug interactions associated with adverse events		Case reported in the World Health Organization (WHO) of individual safety case reports to September 2023