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FABRIC: Atrial Fibrillation in Patients Receiving Ibrutinib

Sponsor
European Georges Pompidou Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04407845
Collaborator
(none)
60
Enrollment
1
Location
30.3
Anticipated Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Etude de l'Incidence et Des Facteurs prédictifs de la Survenue de Fibrillation Atriale Sous Ibrutinib
    Actual Study Start Date :
    May 21, 2020
    Anticipated Primary Completion Date :
    May 21, 2022
    Anticipated Study Completion Date :
    Nov 30, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of cardiovascular events on ibrutinib [6 months]

      Evaluate the incidence of cardiotoxicity (composite endpoint) in a cohort of patients referred to a cardio-oncology before initiation of ibrutinib.

    Secondary Outcome Measures

    1. Incidence of supra-ventricular arrythmias [6 months]

      Number of patients with supra-ventricular arrythmias

    2. Incidence of systemic hypertension [6 months]

      Number of patients with systemic hypertension

    3. Incidence of arterial embolism [6 months]

      Number of patients with systemic hypertension

    4. Incidence of hemorraghe [6 months]

      Number of patients with hemorraghe

    5. Safety mesures [1 year]

      Compare advsere events in patients with supr-ventricular arrhythmias according to the continuation or discontinuation of ibrutinib

    6. Anticoagulants [1 year]

      Correlation between anti thrombotic strategies and cardiovascular outcomes

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • All patients deem to start ibrutinib therapy
    Exclusion Criteria:
    • Past history of ibrutinib therapy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Assistance Publique Hôpitaux de Paris - Centre Université de Paris Paris France 75015

    Sponsors and Collaborators

    • European Georges Pompidou Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mariana Mirabel, MD, PhD, Associate Professor, European Georges Pompidou Hospital
    ClinicalTrials.gov Identifier:
    NCT04407845
    Other Study ID Numbers:
    • 00011928 FABRIC
    First Posted:
    May 29, 2020
    Last Update Posted:
    Jun 9, 2020
    Last Verified:
    Jun 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Mariana Mirabel, MD, PhD, Associate Professor, European Georges Pompidou Hospital
    atrial fibrillation
    haematology
    systemic hypertension
    prognosis
    heart
    Additional relevant MeSH terms:
    Lymphoma, Mantle-Cell
    Leukemia, Lymphocytic, Chronic, B-Cell

    Study Results

    No Results Posted as of Jun 9, 2020