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

NCT06268535 | Completed

• 1 other identifier: CaenUH_DL_1
• Study Type: observational
• Target: 36,580,288
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Cancer, Therapy-Related

Outcome Measures

Primary Outcomes (1)

• Disproportionality individual case data analysis between heart failure of cardiac dysfunction and cancer therapies

  A disproportionality analysis is carried out using stepwise selection procedure and 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 March 2024

Secondary Outcomes (3)

• Description of the population of patients having a heart failure of cardiac dysfunction event with cancer therapies

  Case reported in the World Health Organization (WHO) of individual safety case reports to March 2024

• 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 March 2024

• Description of the drug-drug interactions associated with adverse events

  Case reported in the World Health Organization (WHO) of individual safety case reports to March 2024

Interventions

Cancer therapy with FDA and/or European Medicines Agency approval on the 30th September 2023 DRUG

Disproportionality analysis studying the association between cancer therapy with FDA and/or European Medicines Agency approval on the 30th September 2023 and heart failure or cardiac dysfunction in the World Health Organization pharmacovigilance database.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

Caen University Hospital

Caen, France

Location

Related Publications (1)

• Legallois D, Da Silva A, Alexandre J, Milliez P, Sabatier R, Blanchart K, Plane AF, Font J, Chretien B, Dolladille C. Identification of anticancer drugs associated to cancer therapy-related cardiac dysfunction: a VigiBase(R) disproportionality analysis. Eur Heart J Cardiovasc Pharmacother. 2025 Aug 12;11(5):459-468. doi: 10.1093/ehjcvp/pvaf027.

  PMID: 40272201 DERIVED

MeSH Terms

Conditions

Heart Failure; Neoplasms, Second Primary

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Neoplasms

Study Design

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

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: February 20, 2024
• Study Start: April 1, 2022
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: January 31, 2025

Record last verified: 2023-11

Locations

FR (1)