Atrial Fibrillation in Active Cancer Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Caen
About this trial
Atrial fibrillation is a common complication of both cancer and anticancer drugs but the consequences of such events remain poorly known and are not adressed in both phase III oncological trials and cardiological guidelines. The objective of this study is to create a prospective multicenter international registry of adult patients with an active cancer and experiencing atrial fibrillation to study major cardiovascular events occurrence during a 1 year follow-up.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
adult patients
outpatients or hospitalized patients
with a confirmed cancer (other than basal-cell or squamous-cell carcinoma of the skin, primary brain tumor, known intracerebral metastases, or acute leukemia) and an active cancer (defined as cancer that had been diagnosed within the past 6 months or recurrent locally advanced or metastatic cancer, for which anticancer treatment was being given at the time of enrollment or during 6 months before enrollment)
at least 1 episode of atrial fibrillation (new onset AF occuring after cancer diagnosis or history of paroxysmal of persistant AF prior to cancer diagnosis and an AF recurrence after cancer diagnosis)
Disqualifiers
patient with palliative cares or other conditions resulting in short term death (death expected in the month following atrial fibrillation occurrence)
history of long-standing persistant or permanent AF prior to cancer diagnosis
Trial population
Patients with a cancer will defined as patients with confirmed cancer other than basal-cell or squamous-cell carcinoma of the skin, primary brain tumor, known intracerebral metastases, or acute leukemia. Active cancer will be defined as cancer that had been diagnosed within the past 6 months or recurrent locally advanced or metastatic cancer, and an anticancer treatment given at the time of enrollment or during 6 months before enrollment (according to Agnelli et al. NEJM 2020). AF patients will be both patients with incident AF (first AF episode diagnosed after cancer diagnosis) and those with prevalent AF (AF recurrence occurring after cancer diagnosis and a first AF episode prior to cancer diagnosis)
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
occurence of atrial fibrillation
Other interventionall adult patients with an active cancer and experiencing atrial fibrillation will be consecutively include. Active cancers will be defined according Agnelli et al. (NEJM 2020; 382:1599-1607).
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Occurrence of major cardiovascular events and death of any cause at 1 year
Occurrence of death of any cause, cardiovascular death, heart failure, stroke, myocardial infarction in active cancer patients with atrial fibrillation.
Time frame
from inclusion in the registry to 1 year of follow-upSecondary outcomes
1
Occurrence of major cardiovascular events and death of any cause at 1 year in prevalent and incident AF patients
Occurrence of death of any cause, cardiovascular death, heart failure, stroke, myocardial infarction in active cancer patients according to the AF type (prevalent or incident).
Time frame
from inclusion in the registry to 1 year of follow-up2
Description of the population of active cancer patients experiencing atrial fibrillation (in both prevalent and incidence AF patients).
Description of the population of active cancer patients experiencing atrial fibrillation. Active cancers will be defined according Agnelli et al. (NEJM 2020; 382:1599-1607).
Time frame
at the inclusion in the registry3
Description of the management of atrial fibrillation in cancer patients (in both prevalent and incidence AF patients).
Description of the management (anticoagulants, rhythm or rate control) of atrial fibrillation in cancer patients
Time frame
from inclusion in the registry to 1 year of follow-up4
Description of the population of active cancer patients having a major cardiovascular event
Description of the population of patients having a major cardiovascular event among cancer patients experiencing atrial fibrillation
Time frame
from inclusion in the registry to 1 year of follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Caen
Lead sponsor
University Hospital, Marseille, France
Collaborator
Hospices Civils de Lyon, France
Collaborator
Centre Francois Baclesse, Caen, France
Collaborator
University Hospital of Saint-Etienne, France
Collaborator
Hôpital Lariboisière Fernand Widal, Paris, France
Collaborator
Institut de Cancérologie de l'Ouest Nantes, France
Collaborator
Fundacion Cardio Onco, Santiago, Chile
Collaborator
University of Newcastle, Australia
Collaborator
University Hospital, Rouen
Collaborator
Source ClinicalTrials.gov