Heart FailureNCT06268535
Identification of Anticancer Drugs Associated With Cancer Therapy-related Cardiac Dysfunction: a Pharmacovigilance Study
An observational study of Heart Failure and Cancer, Therapy-Related, run by University Hospital, Caen at 1 site in France.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure, Cancer, Therapy-Related
- What is being tested?
- Cancer therapy with FDA and/or European Medicines Agency approval on the 30th September 2023
- How many people
- 36,580,288 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2022to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification of Anticancer Drugs Associated With Cancer Therapy-related Cardiac Dysfunction: a WHO Pharmacovigilance Database
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.
Read more
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
- Being tested
- Cancer therapy with FDA and/or European Medicines Agency approval on the 30th September 2023
- Medical subject headings
- Heart Failure, Neoplasms, Second Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cancer therapy with FDA and/or European Medicines Agency approval on the 30th September 2023Drug
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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.
Measured: 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
Measured: 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
Measured: Case reported in the World Health Organization (WHO) of individual safety case reports to March 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start1 Apr 2022
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 36,580,288 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06268535
- Sponsor's protocol ID
- CaenUH_DL_1
- Status last verified
- Nov 2023
- First submitted
- 27 Nov 2023
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40272201
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Anticancer Drugs Associated With Cancer Therapy-related Cardiac Dysfunction: a WHO Pharmacovigilance Database
- ClinicalTrials.gov ID
- NCT06268535
- Acronym / sponsor ID
- CaenUH_DL_1
- Conditions
- Heart Failure, Cancer, Therapy-Related
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36,580,288 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cancer therapy with FDA and/or European Medicines Agency approval on the 30th September 2023Disproportionality 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. | Drug | – |
Primary outcome
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).
3 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Derived from this study: PubMed 40272201Legallois 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Cancer, Therapy-Related, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06268535, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2025.