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

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ClinicalTrials.gov Identifier: NCT03924258
Recruitment Status : Not yet recruiting
First Posted : April 23, 2019
Last Update Posted : April 23, 2019
Sponsor:
Information provided by (Responsible Party):
VIFORFRANCE

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 Cacoub (unpublished) on the French national health insurance database showed that iron deficiency was a poorly diagnosed and poorly treated comorbidity.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).

Condition or disease Intervention/treatment Phase
Heart Failure Diagnostic Test: Iron status testing Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1300 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Study of the Prevalence of Iron Deficiency in Patients With Heart Failure
Estimated Study Start Date : May 15, 2019
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure Iron

Arm Intervention/treatment
Experimental: HEART FAILURE
Patients with Heart Failure diagnosis
Diagnostic Test: Iron status testing
Blood sample for iron status testing




Primary Outcome Measures :
  1. Complete blood iron status [ Time Frame: One day ]
    ferritin, Transferrin Saturation Factor



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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Responsible Party: VIFORFRANCE
ClinicalTrials.gov Identifier: NCT03924258     History of Changes
Other Study ID Numbers: CARENFER IC
First Posted: April 23, 2019    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Heart Failure
Anemia, Iron-Deficiency
Heart Diseases
Cardiovascular Diseases
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Iron
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs