Atrial Fibrillation in Active Cancer Patients

Overview

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.

Full Title of Study: “Multicenter International Prospective Registry to Identify Major Cardiovascular Events Associated With the Occurrence of Atrial Fibrillation in Active Cancer Patients”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: September 1, 2023

Interventions

  • Other: occurence of atrial fibrillation
    • all 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).

Clinical Trial Outcome Measures

Primary Measures

  • Occurrence of major cardiovascular events and death of any cause at 1 year
    • Time Frame: from inclusion in the registry to 1 year of follow-up
    • Occurrence of death of any cause, cardiovascular death, heart failure, stroke, myocardial infarction in active cancer patients with atrial fibrillation. These events will be adjudicated by an independent committee.

Secondary Measures

  • Occurrence of major cardiovascular events and death of any cause at 1 year in prevalent and incident AF patients
    • Time Frame: from inclusion in the registry to 1 year of follow-up
    • 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). These events will be adjudicated by an independent committee.
  • Description of the population of active cancer patients experiencing atrial fibrillation (in both prevalent and incidence AF patients).
    • Time Frame: at the inclusion in the registry
    • 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).
  • Description of the management of atrial fibrillation in cancer patients (in both prevalent and incidence AF patients).
    • Time Frame: from inclusion in the registry to 1 year of follow-up
    • Description of the management (anticoagulants, rhythm or rate control) of atrial fibrillation in cancer patients
  • Description of the population of active cancer patients having a major cardiovascular event
    • Time Frame: from inclusion in the registry to 1 year of follow-up
    • Description of the population of patients having a major cardiovascular event among cancer patients experiencing atrial fibrillation
  • Identifying risk factors associated with major cardiovascular events and all cause mortality occurrence
    • Time Frame: from inclusion in the registry to 1 year of follow-up
    • Identifying risk factors (clinical, EKG, biological, echocardiography) of major cardiovascular events and all cause mortality in cancer patients experiencing atrial fibrillation
  • Identifying factors associated with atrial fibrillation recurrence
    • Time Frame: from inclusion in the registry to 1 year of follow-up
    • Identifying factors (clinical, EKG, biological, echocardiography) of atrial fibrillation recurrence in cancer patients
  • Occurrence of major and clinically relevant non-major bleedings (2005 ISTH definition)
    • Time Frame: from inclusion in the registry to 1 year of follow-up
    • Occurrence of major and clinically relevant non-major bleedings in active cancer patients experiencing atrial fibrillation. These events will be adjudicated by an independent committee.
  • Identifying risk factors associated with major and clinically relevant non-major bleedings (2005 ISTH definition)
    • Time Frame: from inclusion in the registry to 1 year of follow-up
    • Identifying risk factors (clinical, EKG, biological, echocardiography) of major and clinically relevant non-major bleedings in active cancer patients experiencing atrial fibrillation

Participating in This Clinical Trial

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) – with 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 or AF recurrence) Exclusion Criteria:

  • patient with palliative cares or other conditions resulting in short term death (death expected in the month following atrial fibrillation occurrence)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Caen
  • Collaborator
    • Groupe Hospitalier Pitie-Salpetriere
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Joachim Alexandre, MD, PhD, Principal Investigator, Caen Normandy University Hospital, France
  • Overall Contact(s)
    • Joachim Alexandre, MD, PhD, +330231064770, alexandre-j@chu-caen.fr

References

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. Review.

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.

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