Atrial Fibrillation in Active Cancer Patients

Recruiting

• Conditions: Atrial Fibrillation; Drug Toxicity; Cancer; Cardiovascular Complication

• Registration Number: NCT04696081
• Lead Sponsor: University Hospital, Caen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-04
• Study First Submitted QC: 2021-01-04
• Study First Posted: 2021-01-06
• Study Start: 2021-09-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-08-08
• Last Update Posted: 2024-08-09
• Primary Completion: 2025-09-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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).
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
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
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).
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
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
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.

Trial Locations

Locations (1)

Alexandre; 🇫🇷 Caen, Normandy, France