A Study to Compare the Use of Ferric Carboxymaltose With Placebo in Patients With Chronic Heart Failure and Iron Deficiency

Chronic Heart Failure Clinical Trial

— CONFIRM-HF  

Official title:

A Randomised, Double-blind Controlled Phase 4 Study to Compare the Efficacy and Safety of Intravenous Ferric Carboxymaltose With Placebo in Patients With Chronic Heart Failure and Iron Deficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01453608
• Other study ID #: FER-CARS-05
• Status: Completed
• Phase: Phase 4
• First received: October 13, 2011
• Last updated: March 17, 2015
• Start date: October 2011
• Est. completion date: January 2015

Study information

• Verified date: March 2015
• Source: Vifor Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Office for Safety in Health CareAustria: EthikkommissionFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Institutional Ethical CommitteeGermany: Federal Institute for Drugs and Medical DevicesGermany: Ethics CommissionIreland: Ministry of HealthIreland: Medical Ethics Research CommitteeItaly: Ethics CommitteeItaly: Ministry of HealthPoland: Ethics CommitteePoland: Ministry of HealthPortugal: National Pharmacy and Medicines InstitutePortugal: Ethics Committee for Clinical ResearchRussia: Ministry of Health of the Russian FederationRussia: Ethics CommitteeSpain: Ethics CommitteeSpain: Ministry of HealthSweden: Medical Products AgencySweden: Institutional Review BoardUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics CommitteeUkraine: Ministry of HealthUkraine: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine, relative to placebo, the effect of iron repletion therapy using intravenous (IV) ferric carboxymaltose on exercise capacity in patients with chronic heart failure and iron deficiency.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 304
• Est. completion date: January 2015
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• 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 left ventricular ejection fraction

• Capable of completing 6 minute walk test

• 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

• Body weight = 35 kg

• No other significant cardiac or general disorders that would compromise the ability to give informed consent and/or comply with study procedures

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• Ferinject (ferric carboxymaltose)
Subjects will receive Ferinject (ferric carboxymaltose) intravenously on Day 0
• Placebo (saline)
Subjects will receive Placebo (saline) intravenously on Day 0

Locations

Country	Name	City	State
Poland	Clinical Military Hospital	Wroclaw
Russian Federation	State Educational Institution of Higer Professional Education	Ryazan

Sponsors (2)

Lead Sponsor	Collaborator
Vifor Inc.	ICON Clinical Research

Countries where clinical trial is conducted

Poland,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in six minute walk test from baseline to week 24		24 weeks	No

External Links

•   Beneficial effects of long-term intravenous iron therapy with ferric carboxymaltose in patients with symptomatic heart failure and iron deficiency. Confirm HF