Atrial Fibrillation in Active Cancer Patients

NCT ID: NCT04696081

Last Updated: 2024-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-01

Study Completion Date

2026-01-01

Brief Summary

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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

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Conditions

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Cancer Drug Toxicity Atrial Fibrillation Cardiovascular Complication

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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).

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Marseille, France

UNKNOWN

Sponsor Role collaborator

Hospices Civils de Lyon, France

UNKNOWN

Sponsor Role collaborator

Centre Francois Baclesse, Caen, France

UNKNOWN

Sponsor Role collaborator

University Hospital of Saint-Etienne, France

UNKNOWN

Sponsor Role collaborator

Hôpital Lariboisière Fernand Widal, Paris, France

UNKNOWN

Sponsor Role collaborator

Institut de Cancérologie de l'Ouest Nantes, France

UNKNOWN

Sponsor Role collaborator

Fundacion Cardio Onco, Santiago, Chile

UNKNOWN

Sponsor Role collaborator

Hunter New England Area Health Service, University of Newcastle, Australia

UNKNOWN

Sponsor Role collaborator

University Hospital, Rouen

OTHER

Sponsor Role collaborator

University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joachim Alexandre, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Caen Normandy University Hospital, France

Locations

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Alexandre

Caen, Normandy, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Joachim Alexandre, MD, PhD

Role: CONTACT

+330231064770

Facility Contacts

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Joachim ALEXANDRE, MD, PhD

Role: primary

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 29698683 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32353110 (View on PubMed)

Other Identifiers

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Pharmaco122020

Identifier Type: -

Identifier Source: org_study_id

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