Atrial Fibrillation in Active Cancer Patients (AFIB-CANCER)

Multicenter International Prospective Registry to Identify Major Cardiovascular Events Associated With the Occurrence of Atrial Fibrillation in Active Cancer Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer; Atrial Fibrillation; Drug Toxicity; Cardiovascular Complication
• Intervention / Treatment: Other: occurence of atrial fibrillation

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Joachim ALEXANDRE, MD, PhD; Phone Number: +330231064770; Email: alexandre-j@chu-caen.fr

Study Locations

• France
  • Normandy
    • Caen, Normandy, France, 14000
      • Recruiting
      • Alexandre
      • Contact: Joachim ALEXANDRE, MD, PhD
      • Contact: Email: alexandre-j@chu-caen.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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)

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	from inclusion in the registry to 1 year of follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	from inclusion in the registry to 1 year of follow-up
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).	at the inclusion in the registry
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	from inclusion in the registry to 1 year of follow-up
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	from inclusion in the registry to 1 year of follow-up
Identifying risk factors associated with major cardiovascular events and all cause mortality occurrence	Identifying risk factors (clinical, EKG, biological, echocardiography) of major cardiovascular events and all cause mortality in cancer patients experiencing atrial fibrillation	from inclusion in the registry to 1 year of follow-up
Identifying factors associated with atrial fibrillation recurrence	Identifying factors (clinical, EKG, biological, echocardiography) of atrial fibrillation recurrence in cancer patients	from inclusion in the registry to 1 year of follow-up
Occurrence of major and clinically relevant non-major bleedings (2005 ISTH definition)	Occurrence of major and clinically relevant non-major bleedings in active cancer patients experiencing atrial fibrillation.	from inclusion in the registry to 1 year of follow-up
Identifying risk factors associated with major and clinically relevant non-major bleedings (2005 ISTH definition)	Identifying risk factors (clinical, EKG, biological, echocardiography) of major and clinically relevant non-major bleedings in active cancer patients experiencing atrial fibrillation	from inclusion in the registry to 1 year of follow-up

Collaborators and Investigators

• Sponsor: University Hospital, Caen
• Collaborators: Heidelberg University; Groupe Hospitalier Pitie-Salpetriere; University Hospital, Marseille, France; Hospices Civils de Lyon, France; University of Pennsylvania, USA; Centre Francois Baclesse, Caen, France; Saint Antoine University Hospital, Paris, France; Vanderbilt University Medical Center, USA; University Hospital of Saint-Etienne, France; Hôpital Lariboisière Fernand Widal, Paris, France; University Hospital, Rennes, France; Hospital Universitario La Paz, Spain; Institut de Cancérologie de l'Ouest Nantes, France; Fundacion Cardio Onco, Santiago, Chile; Hunter New England Area Health Service, University of Newcastle, Australia; Cardiology Division, University of Modena and Reggio Emilia, Policlinico di Modena, Italy
• Investigators: Principal Investigator: Joachim ALEXANDRE, MD, PhD, Caen Normandy University Hospital, France

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): January 1, 2024

Study Registration Dates

• First Submitted: January 4, 2021
• First Submitted That Met QC Criteria: January 4, 2021
• First Posted (Actual): January 6, 2021

Study Record Updates

• Last Update Posted (Actual): October 3, 2022
• Last Update Submitted That Met QC Criteria: September 30, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Drug-Related Side Effects and Adverse Reactions
• Other Study ID Numbers: Pharmaco122020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No