NCT03924258

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 Cacoub (unpublished) on the French national health insurance database showed that iron deficiency was a poorly diagnosed and poorly treated comorbidity.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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,300

participants targeted

Target at P75+ for not_applicable heart-failure

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable heart-failure

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 23, 2019

Completed
22 days until next milestone

Study Start

First participant enrolled

May 15, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

April 23, 2019

Status Verified

April 1, 2019

Enrollment Period

2 months

First QC Date

April 18, 2019

Last Update Submit

April 18, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Complete blood iron status

    ferritin, Transferrin Saturation Factor

    One day

Study Arms (1)

HEART FAILURE

EXPERIMENTAL

Patients with Heart Failure diagnosis

Diagnostic Test: Iron status testing

Interventions

Iron status testingDIAGNOSTIC_TEST

Blood sample for iron status testing

HEART FAILURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2019

First Posted

April 23, 2019

Study Start

May 15, 2019

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

April 23, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share