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Completed

NCT Number: NCT06268535

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Caen University Hospital

Caen, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

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

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

    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).

Secondary outcomes

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

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

    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.

  2. Description of the pathologies (cancer) for which the incriminated drugs have been prescribed

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

  3. Description of the drug-drug interactions associated with adverse events

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

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 20, 2024
Registry last updated
Jan 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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