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Study of the Prevalence of Iron Deficiency in Patients With Heart Failure (CARENFER IC)

Primary Purpose

Heart Failure

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Iron status testing
Sponsored by
VIFORFRANCE
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient, male or female, over 18 years of age
  • Patient present at the hospital on the day of the study
  • Diagnosis of Heart Failure (acute or chronic) regardless of left ventricular ejection fraction (LVEF)
  • Patient with signed consent

Exclusion Criteria:

  • Protected patient: major under guardianship, tutorship or other legal protection, deprived of liberty by judicial or administrative decision
  • Pregnant or breastfeeding woman

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    HEART FAILURE

    Arm Description

    Patients with Heart Failure diagnosis

    Outcomes

    Primary Outcome Measures

    Complete blood iron status
    ferritin, Transferrin Saturation Factor

    Secondary Outcome Measures

    Full Information

    First Posted
    April 18, 2019
    Last Updated
    April 18, 2019
    Sponsor
    VIFORFRANCE
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03924258
    Brief Title
    Study of the Prevalence of Iron Deficiency in Patients With Heart Failure
    Acronym
    CARENFER IC
    Official Title
    Study of the Prevalence of Iron Deficiency in Patients With Heart Failure
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 15, 2019 (Anticipated)
    Primary Completion Date
    June 30, 2019 (Anticipated)
    Study Completion Date
    June 30, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    VIFORFRANCE

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Despite its known prevalence in Heart Failure, a recent study conducted by Prof. Cacoub (unpublished) on the French national health insurance database showed that iron deficiency was a poorly diagnosed and poorly treated comorbidity. In chronic diseases including Heart Failure, Transferrin Saturation Factor is only performed in about 10% of cases while it is recommended for patients with Heart Failure (French Health High Authority 2011). The purpose of this study is to obtain current data on the prevalence of iron deficiency in France in patients with Heart Failure, applying the recommendations of European Society of Cardiology and French Health High Authority (determination of ferritinemia and Transferrin Saturation Factor).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Failure

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    1300 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    HEART FAILURE
    Arm Type
    Experimental
    Arm Description
    Patients with Heart Failure diagnosis
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Iron status testing
    Intervention Description
    Blood sample for iron status testing
    Primary Outcome Measure Information:
    Title
    Complete blood iron status
    Description
    ferritin, Transferrin Saturation Factor
    Time Frame
    One day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patient, male or female, over 18 years of age Patient present at the hospital on the day of the study Diagnosis of Heart Failure (acute or chronic) regardless of left ventricular ejection fraction (LVEF) Patient with signed consent Exclusion Criteria: Protected patient: major under guardianship, tutorship or other legal protection, deprived of liberty by judicial or administrative decision Pregnant or breastfeeding woman

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Study of the Prevalence of Iron Deficiency in Patients With Heart Failure

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