Atrial Fibrillation in Active Cancer Patients

NCT04696081 | Recruiting

• 1 other identifier: Pharmaco122020
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Drug Toxicity; Atrial Fibrillation; Cardiovascular Complication

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

• 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 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 population of active cancer patients having a major cardiovascular event

  from inclusion in the registry to 1 year of follow-up

• Identifying risk factors associated with major cardiovascular events and all cause mortality occurrence

  from inclusion in the registry to 1 year of follow-up

Interventions

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a cancer will defined as patients with confirmed cancer other than basal-cell or squamous-cell carcinoma of the skin, primary brain tumor, known intracerebral metastases, or acute leukemia. Active cancer will be defined as cancer that had been diagnosed within the past 6 months or recurrent locally advanced or metastatic cancer, and an anticancer treatment given at the time of enrollment or during 6 months before enrollment (according to Agnelli et al. NEJM 2020). AF patients will be both patients with incident AF (first AF episode diagnosed after cancer diagnosis) and those with prevalent AF (AF recurrence occurring after cancer diagnosis and a first AF episode prior to cancer diagnosis)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Alexandre

Caen, Normandy, 14000, France

RECRUITING

Related 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.

  PMID: 29698683 BACKGROUND

• 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.

  PMID: 32353110 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Drug-Related Side Effects and Adverse Reactions; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Joachim Alexandre, MD, PhD

  Caen Normandy University Hospital, France

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joachim Alexandre, MD, PhD

CONTACT

+330231064770; alexandre-j@chu-caen.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2021
• First Posted: January 6, 2021
• Study Start: September 1, 2021
• Primary Completion: September 1, 2025
• Study Completion: January 1, 2026
• Last Updated: August 9, 2024

Record last verified: 2024-07

Locations

FR (1)