MedTrace Logo

EFfect of Ferric Carboxymaltose on exercIse CApacity and Cardiac Function in Patients With Iron deficiencY and Chronic Heart Failure

NCT00821717 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2015-06-03

No results posted yet for this study

Summary

This study is designed to assess, relative to placebo, the effects on the evolution of exercise capacity and symptomatic status of the addition of iron treatment with FCM (ferric carboxymaltose) to the basic regimen of ambulatory patients with stable symptomatic chronic CHF (congestive heart failure) and iron deficiency.

Conditions

Interventions

DRUG

Ferinject ® (Ferric carboxymaltose)

Ferinject® will be administered in doses of 200 mg (4 mL) weekly up to iron repletion (correction phase of variable duration depending on individual iron deficit). The calculated dose will be rounded to the next 100 mg iron, i.e. the final dose may be 100 mg iron depending on the individual iron deficit. After the correction phase, Ferinject® will be given monthly in doses of 200 mg until the 24th week (maintenance phase).

DRUG

Normal saline (0.9%)

During the correction phase, patients will receive the number of normal saline injections (4 mL weekly) corresponding to the calculated total iron dose needed according to the individual iron deficit. During the maintenance phase, placebo patients will receive 4 mL normal saline monthly.

Sponsors & Collaborators

  • Socar Research SA

    collaborator NETWORK

  • Vifor Pharma

    lead INDUSTRY

Principal Investigators

  • Michael Motro, MD, FACC · Sheba Medical Center, Tel-Hashomer 52621, Israel

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2009-10-31
Completion
2011-01-31

Countries

  • Denmark
  • France
  • Germany
  • Israel
  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00821717 on ClinicalTrials.gov