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NCT06268535Completed

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

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

Source: ClinicalTrials.gov · Last updated 31 Jan 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
36580288 (actual)
First submitted
27 Nov 2023
Start date
1 Apr 2022
Primary completion date
30 Jun 2024
Lead sponsor
University Hospital, Caen
NCT number
NCT06268535

What you commit to

  • Study type: Observational
  • Participants enrolled: 36580288
  • From 1 Apr 2022 to the primary completion date, 30 Jun 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

  • 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).

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Caen University Hospital
Coordinator of this site? Confirm its status
CaenFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.