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FranceLEVO - Zimino Registry (FZR)

Sponsor
Arcothova (Other)
Overall Status
Completed
CT.gov ID
NCT04252404
Collaborator
(none)
600
Enrollment
1
Location
15
Actual Duration (Months)
39.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The French National Authority for Health (Haute Autorité de santé) requested a registry study to obtain post-market surveillance data to describe baseline clinical profiles, management and outcome of patients treated with Zimino®. This study is designed to provide real-life data on the use, safety and clinical outcomes of Zimino® in routine clinical practice in France.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This is a real-life, non-interventional, observational, multicentre study in all patients (including children) receiving Zimino® in France.

    The patients will be evaluated during the index hospitalisation and on follow-up days 30 (±15) and 90 (±15) after hospital discharge. The follow-up can be a phone call or a visit to the hospital. Patients who meet the eligibility criteria will be identified consecutively at each hospital. The participating hospitals will vary in size and medical activities, depending on their location and the population size they serve.

    The physician will determine the patient's treatment strategy. Drug prescriptions and the indications to perform diagnostic or therapeutic procedures will be left completely to the discretion of the physicians.

    The estimated enrollment period is 12 months (enrollment of the first patient - enrollment of the last patient), or less if the cohort (n=600) is completed earlier, and the maximum total data collection period is 15 months.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    600 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    FranceLEVO - Zimino® Registry: a French Registry Evaluating the Use of Levosimendan (Zimino®)
    Actual Study Start Date :
    Feb 3, 2020
    Actual Primary Completion Date :
    Jan 27, 2021
    Actual Study Completion Date :
    May 6, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Indication for levosimendan (Zimino) [from January 28, 2020 until January 28, 2021]

      Physicians will be requested to choose one of the following indications (pop-up list): Cardiogenic shock (medical setting or post cardiac surgery) Heart failure decompensation (medical, setting) Low cardiac output syndrome (post cardiac surgery) Heart failure decompensation in a patient receiving beta-blockers ECMO weaning Repetitive use in a patient with end-stage heart failure Other (text)

    2. Dose of levosimendan (Zimino) (in µg/kg/min) [from January 28, 2020 until January 28, 2021]

      Physicians will be requested to describe the levosimendan regimen used: A) Loading dose (in µg/kg) B) Dose of the continuous infusion (in µg/kg/min)

    3. Duration of levosimendan (Zimino) infusion [from January 28, 2020 until January 28, 2021]

      Number of hours during which the patient received levosimendan

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients receiving Zimino® treatment

    • Patients or patient's families not objecting to the patient's participation in the study.

    Exclusion Criteria:
    • None

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hôpital Européen Georges Pompidou, AP-HP Paris Ile De France France 75015

    Sponsors and Collaborators

    • Arcothova

    Investigators

    • Principal Investigator: Bernard CHOLLEY, MD, PhD, Arcothova

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Cholley Bernard, Coordinating Investigator, Arcothova
    ClinicalTrials.gov Identifier:
    NCT04252404
    Other Study ID Numbers:
    • Arcothova
    First Posted:
    Feb 5, 2020
    Last Update Posted:
    Jul 21, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Cholley Bernard, Coordinating Investigator, Arcothova
    low cardiac output syndrome
    cardiogenic shock
    Additional relevant MeSH terms:
    Heart Failure

    Study Results

    No Results Posted as of Jul 21, 2021