Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04696081

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Cancer Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Complication Cardiovascular Diseases Chemically-Induced Disorders Drug Toxicity Drug-Related Side Effects and Adverse Reactions Heart Diseases Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Alexandre

Caen, Normandy, 14000, France

Location status: Recruiting

Location contact

Joachim ALEXANDRE, MD, PhD

CONTACT

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

occurence of atrial fibrillation

Other

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).

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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).

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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.

  8. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Joachim Alexandre, MD, PhD

CONTACT

[email protected]

+330231064770

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Collaborators

  • Centre Francois Baclesse, Caen, France
  • Fundacion Cardio Onco, Santiago, Chile
  • Hospices Civils de Lyon, France
  • Hôpital Lariboisière Fernand Widal, Paris, France
  • Institut de Cancérologie de l'Ouest Nantes, France
  • University Hospital of Saint-Etienne, France
  • University Hospital, Marseille, France
  • University Hospital, Rouen
  • University of Newcastle, Australia

Registry information

Official study title

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

Acronym: AFIB-CANCER

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Jan 6, 2021
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.