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ICARE: Cardiovascular Complications of Carfilzomib

Sponsor
European Georges Pompidou Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT04407858
Collaborator
(none)
60
Enrollment
1
Location
24
Anticipated Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Cardiovascular toxicity of carfilzomib, a last generation proteasome inhibitor, is highly incident according to retrospective data. Prospective cohort study of patients initiated on carfilzomib.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Insuffisance Cardiaque Sous Carfilzomib: étude Prospective
    Actual Study Start Date :
    May 21, 2020
    Anticipated Primary Completion Date :
    May 21, 2021
    Anticipated Study Completion Date :
    May 21, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of cardio-vasculo-toxicity of carfilzomib [6 months]

      Number of patients with cardio-toxicity (composite endpoint) in a cohort of patients referred to a cardio-oncology before initiation of carfilzomib.

    Secondary Outcome Measures

    1. Systemic hypertension [6 months]

      Number of patients with as systemic hypertension

    2. Heart Failure Reduced Ejection Fraction [6 months]

      Number of patients with Heart Failure and Reduced Ejection Fraction

    3. Heart Failure Preserved Ejection Fraction [6 months]

      Number of patients with Heart Failure and Preserved Ejection Fraction

    4. Predictors of Cardiotoxicity [6 months]

      Correlation between cardio-vascular toxicity and patients' chacateristics.

    5. Impact on outcomes [1 year]

      Compare outcomes (mortality) in patients with cardiotoxicity and no cardiotoxicty.

    6. Safety [1 year]

      Compare outcomes (mortality) in patients with cardiotoxicity according to the continuation of carflzomib or its withdrawl.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Intention to treat by Carfilzomib
    Exclusion Criteria:
    • History of carfilzomib treatment

    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

    • Principal Investigator: Mariana Mirabel, Assistance Publique Hôpitaux de Paris - Université de Paris

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mariana Mirabel, Associate Professor, European Georges Pompidou Hospital
    ClinicalTrials.gov Identifier:
    NCT04407858
    Other Study ID Numbers:
    • 00011928 ICARE
    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, Associate Professor, European Georges Pompidou Hospital
    Adverse drug event
    Additional relevant MeSH terms:
    Heart Failure

    Study Results

    No Results Posted as of Jun 9, 2020