Atrial Fibrillation in Patients Receiving Ibrutinib (FABRIC)

June 4, 2020 updated by: Mariana Mirabel, European Georges Pompidou Hospital

Etude de l'Incidence et Des Facteurs prédictifs de la Survenue de Fibrillation Atriale Sous Ibrutinib

Ibrutinib (a tyrosine kinase inhibitor targeting Bruton) is a standard of treatment in haematology. According to retrospective data, atrial fibrillation and systemic hypertension are common ibrutinib-related advserse events. The investigators aim at prospectively establishing the incidence of thesedrug related advsere events through clinical monitoring and attempt at identifying populations at risk.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Paris, France, 75015
        • Recruiting
        • Assistance Publique Hôpitaux de Paris - Centre Université de Paris
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Prospective consecutive cohort

Description

Inclusion Criteria:

  • All patients deem to start ibrutinib therapy

Exclusion Criteria:

  • Past history of ibrutinib therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of cardiovascular events on ibrutinib
Time Frame: 6 months
Evaluate the incidence of cardiotoxicity (composite endpoint) in a cohort of patients referred to a cardio-oncology before initiation of ibrutinib.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of supra-ventricular arrythmias
Time Frame: 6 months
Number of patients with supra-ventricular arrythmias
6 months
Incidence of systemic hypertension
Time Frame: 6 months
Number of patients with systemic hypertension
6 months
Incidence of arterial embolism
Time Frame: 6 months
Number of patients with systemic hypertension
6 months
Incidence of hemorraghe
Time Frame: 6 months
Number of patients with hemorraghe
6 months
Safety mesures
Time Frame: 1 year
Compare advsere events in patients with supr-ventricular arrhythmias according to the continuation or discontinuation of ibrutinib
1 year
Anticoagulants
Time Frame: 1 year
Correlation between anti thrombotic strategies and cardiovascular outcomes
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Georges Pompidou Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 21, 2020

Primary Completion (Anticipated)

May 21, 2022

Study Completion (Anticipated)

November 30, 2022

Study Registration Dates

First Submitted

May 14, 2020

First Submitted That Met QC Criteria

May 28, 2020

First Posted (Actual)

May 29, 2020

Study Record Updates

Last Update Posted (Actual)

June 9, 2020

Last Update Submitted That Met QC Criteria

June 4, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00011928 FABRIC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Mantle Cell Lymphoma

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Italy

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe