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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03924258
Other study ID # CARENFER IC
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 15, 2019
Est. completion date June 30, 2019

Study information

Verified date April 2019
Source VIFORFRANCE
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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 Cacoub (unpublished) on the French national health insurance database showed that iron deficiency was a poorly diagnosed and poorly treated comorbidity.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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1300
Est. completion date June 30, 2019
Est. primary completion date June 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Iron status testing
Blood sample for iron status testing

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
VIFORFRANCE

Outcome

Type Measure Description Time frame Safety issue
Primary Complete blood iron status ferritin, Transferrin Saturation Factor One day
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