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

Chronic Heart Failure Clinical Trial

— EFFECT-HF  

Official title:

Multicentre, Prospective, Randomised, 2-arm Study to Assess the Impact of Ferric Carboxymaltose on Exercise Capacity in Chronic Heart Failure Patients With Iron Deficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01394562
• Other study ID #: FER-CARS-04
• Secondary ID: 2011-000603-40
• Status: Completed
• Phase: Phase 3
• First received: July 12, 2011
• Last updated: May 16, 2017
• Start date: July 2011
• Est. completion date: May 2016

Study information

• Verified date: December 2015
• Source: Vifor Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Iron deficient subjects with stable chronic heart failure (CHF) (NYHA II-III) on optimal background therapy for CHF

• Reduced exercise capacity

• Reduced left ventricular ejection fraction

• At least 18 years of age and with written informed consent prior to any study specific procedures

Exclusion Criteria:

• Erythropoietin stimulating agent (ESA) use, IV iron therapy, and/or blood transfusion in previous 6 weeks prior to randomisation

• Exercise training program(s) in the 3 months prior to screening or planned in the next 6 months

• Chronic liver disease and/or elevated liver enzymes

• Vitamin B12 and/or serum folate deficiency

• Subject is not using adequate contraceptive precautions during the study

• No other significant cardiac or general disorder that would compromise participation in the study

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Chronic Heart Failure
• Heart Failure
• Iron Deficiency

Intervention

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

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
Vifor Inc.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Peak VO2 (mL/kg/min) from baseline to Week 24		Week 24