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Atrial Fibrillation in Patients Receiving Ibrutinib (FABRIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04407845
Recruitment Status : Recruiting
First Posted : May 29, 2020
Last Update Posted : June 9, 2020
Information provided by (Responsible Party):
Mariana Mirabel, European Georges Pompidou Hospital

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
Leukemia, Chronic Lymphatic Mantle Cell Lymphoma

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Study Type : Observational
Estimated 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
Estimated Primary Completion Date : May 21, 2022
Estimated Study Completion Date : November 30, 2022

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Incidence of supra-ventricular arrythmias [ Time Frame: 6 months ]
    Number of patients with supra-ventricular arrythmias

  2. Incidence of systemic hypertension [ Time Frame: 6 months ]
    Number of patients with systemic hypertension

  3. Incidence of arterial embolism [ Time Frame: 6 months ]
    Number of patients with systemic hypertension

  4. Incidence of hemorraghe [ Time Frame: 6 months ]
    Number of patients with hemorraghe

  5. Safety mesures [ Time Frame: 1 year ]
    Compare advsere events in patients with supr-ventricular arrhythmias according to the continuation or discontinuation of ibrutinib

  6. Anticoagulants [ Time Frame: 1 year ]
    Correlation between anti thrombotic strategies and cardiovascular outcomes

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Prospective consecutive cohort

Inclusion Criteria:

  • All patients deem to start ibrutinib therapy

Exclusion Criteria:

  • Past history of ibrutinib therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04407845

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Contact: Mariana Mirabel, MD, PHD +33156095636

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Assistance Publique Hôpitaux de Paris - Centre Université de Paris Recruiting
Paris, France, 75015
Contact: Mariana Mirabel, MD, PhD    +33156095636   
Sponsors and Collaborators
European Georges Pompidou Hospital
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Responsible Party: Mariana Mirabel, MD, PhD, Associate Professor, European Georges Pompidou Hospital Identifier: NCT04407845    
Other Study ID Numbers: 00011928 FABRIC
First Posted: May 29, 2020    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mariana Mirabel, European Georges Pompidou Hospital:
atrial fibrillation
systemic hypertension
Additional relevant MeSH terms:
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Lymphoma, Mantle-Cell
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Leukemia, Lymphoid