Clinical trial NCT04696081: Atrial Fibrillation in Active Cancer Patients
Official title: Multicenter International Prospective Registry to Identify Major Cardiovascular Events Associated With the Occurrence of Atrial Fibrillation in Active Cancer Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Drug Toxicity
Atrial Fibrillation
Cardiovascular Complication
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
Collaborators: name: University Hospital, Marseille, France
name: Hospices Civils de Lyon, France
name: Centre Francois Baclesse, Caen, France
name: University Hospital of Saint-Etienne, France
name: Hôpital Lariboisière Fernand Widal, Paris, France
name: Institut de Cancérologie de l'Ouest Nantes, France
name: Fundacion Cardio Onco, Santiago, Chile
name: Hunter New England Area Health Service, University of Newcastle, Australia
name: University Hospital, Rouen
First posted: 2021-01-06
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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)

Brief summary: 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: Inclusion Criteria:

* 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)
* in sinus rhythm at the time of cancer diagnosis

Exclusion Criteria:

* 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

Primary outcomes:
measure: Occurrence of major cardiovascular events and death of any cause at 1 year
timeFrame: from inclusion in the registry to 1 year of follow-up
Secondary outcomes:
measure: Occurrence of major cardiovascular events and death of any cause at 1 year in prevalent and incident AF patients
timeFrame: from inclusion in the registry to 1 year of follow-up
measure: Description of the population of active cancer patients experiencing atrial fibrillation (in both prevalent and incidence AF patients).
timeFrame: at the inclusion in the registry
measure: Description of the management of atrial fibrillation in cancer patients (in both prevalent and incidence AF patients).
timeFrame: from inclusion in the registry to 1 year of follow-up
measure: Description of the population of active cancer patients having a major cardiovascular event
timeFrame: from inclusion in the registry to 1 year of follow-up
measure: Identifying risk factors associated with major cardiovascular events and all cause mortality occurrence
timeFrame: from inclusion in the registry to 1 year of follow-up
measure: Identifying factors associated with atrial fibrillation recurrence
timeFrame: from inclusion in the registry to 1 year of follow-up
measure: Occurrence of major and clinically relevant non-major bleedings (2005 ISTH definition)
timeFrame: from inclusion in the registry to 1 year of follow-up
measure: Identifying risk factors associated with major and clinically relevant non-major bleedings (2005 ISTH definition)
timeFrame: from inclusion in the registry to 1 year of follow-up
Other outcomes:
Locations:
city: Caen
country: France
facility: Alexandre
state: Normandy
Study officials:
affiliation: Caen Normandy University Hospital, France
name: Joachim Alexandre, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alexandre J, Moslehi JJ, Bersell KR, Funck-Brentano C, Roden DM, Salem JE. Anticancer drug-induced cardiac rhythm disorders: Current knowledge and basic underlying mechanisms. Pharmacol Ther. 2018 Sep;189:89-103. doi: 10.1016/j.pharmthera.2018.04.009. Epub 2018 Apr 24.
citation: Alexandre J, Salem JE, Moslehi J, Sassier M, Ropert C, Cautela J, Thuny F, Ederhy S, Cohen A, Damaj G, Vilque JP, Plane AF, Legallois D, Champ-Rigot L, Milliez P, Funck-Brentano C, Dolladille C. Identification of anticancer drugs associated with atrial fibrillation: analysis of the WHO pharmacovigilance database. Eur Heart J Cardiovasc Pharmacother. 2021 Jul 23;7(4):312-320. doi: 10.1093/ehjcvp/pvaa037.