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

April 18, 2019 updated by: VIFORFRANCE
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 Cacoub (unpublished) on the French national health insurance database showed that iron deficiency was a poorly diagnosed and poorly treated comorbidity.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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1300

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HEART FAILURE
Patients with Heart Failure diagnosis
Diagnostic test: Iron status testing
Blood sample for iron status testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete blood iron status
Time Frame: One day
ferritin, Transferrin Saturation Factor
One day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VIFORFRANCE

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 15, 2019

Primary Completion (Anticipated)

June 30, 2019

Study Completion (Anticipated)

June 30, 2019

Study Registration Dates

First Submitted

April 18, 2019

First Submitted That Met QC Criteria

April 18, 2019

First Posted (Actual)

April 23, 2019

Study Record Updates

Last Update Posted (Actual)

April 23, 2019

Last Update Submitted That Met QC Criteria

April 18, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CARENFER IC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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