Atrial Fibrillation in Active Cancer Patients

Cancer Clinical Trial

— AFIB-CANCER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04696081
• Other study ID #: Pharmaco122020
• Status: Recruiting
• Start date: September 1, 2021
• Est. completion date: January 1, 2024

Study information

• Verified date: June 2022
• Source: University Hospital, Caen
• Contact: Joachim Alexandre, MD, PhD
• Phone: +330231064770
• Email: alexandre-j[@]chu-caen.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: January 1, 2024
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Cancer
• Cardiovascular Complication
• Drug Toxicity
• Drug-Related Side Effects and Adverse Reactions

Intervention

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).

Locations

Country	Name	City	State
France	Alexandre	Caen	Normandy

Sponsors (17)

Lead Sponsor

Collaborator

University Hospital, Caen

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

Country where clinical trial is conducted

France, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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