AFIB-CANCER: Atrial Fibrillation in Active Cancer Patients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- Occurrence of major cardiovascular events and death of any cause at 1 year [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 Outcome Measures
- Occurrence of major cardiovascular events and death of any cause at 1 year in prevalent and incident AF patients [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). [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). [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 [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 [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 [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) [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) [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
Eligibility Criteria
Criteria
Inclusion Criteria:
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adult patients
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outpatients or hospitalized patients
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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)
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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)
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in sinus rhythm at the time of cancer diagnosis
Exclusion Criteria:
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patient with palliative cares or other conditions resulting in short term death (death expected in the month following atrial fibrillation occurrence)
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history of long-standing persistant or permanent AF prior to cancer diagnosis
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Alexandre | Caen | Normandy | France | 14000 |
Sponsors and Collaborators
- University Hospital, Caen
- Groupe Hospitalier Pitie-Salpetriere
- University Hospital, Marseille
- Hospices Civils de Lyon
- University of Pennsylvania
- Centre Francois Baclesse
- Saint Antoine University Hospital
- Vanderbilt University Medical Center
- University Hospital of Saint-Etienne
- Hôpital Lariboisière Fernand Widal
- Rennes University Hospital
- Hospital Universitario La Paz
- Institut de Cancérologie de l'Ouest Nantes
Investigators
- Principal Investigator: Joachim Alexandre, MD, PhD, Caen Normandy University Hospital, France
Study Documents (Full-Text)
None provided.More Information
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. 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.
- Pharmaco122020