MedTrace Logo

Effect of Ferric Carboxymaltose on Exercise Capacity in Patients With Iron Deficiency and Chronic Heart Failure

NCT01394562 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 174

Last updated 2017-05-18

No results posted yet for this study

Summary

The purpose of this study is to confirm that treatment with IV ferric carboxymaltose improves exercise capacity, physical functioning and quality of life in patients with iron deficiency and chronic heart failure.

Conditions

Interventions

DRUG

Ferinject (ferric carboxymaltose)

Subjects will receive ferric carboxymaltose intravenously on Day 0, Week 6, and Week 12

OTHER

Standard of Care

Subjects randomised to Standard of Care may receive oral iron at Investigator's discretion however patients will not be permitted to receive IV iron

Sponsors & Collaborators

  • Vifor Pharma

    lead INDUSTRY

Principal Investigators

  • Dirk van Veldhuisen, MD · University Medical Center Groningen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • 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 NCT01394562 on ClinicalTrials.gov