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

Chronic Heart Failure Clinical Trial

— EFFICACY-HF  

Official title:

A Randomised, Controlled, Observer-blinded Phase III Clinical Trial to Compare the Effect of Intravenous Ferric Carboxymaltose to Placebo on Exercise Capacity and Cardiac Function in Patients With Chronic Heart Failure and Iron Deficiency

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00821717
• Other study ID #: FER-CARS-03
• Status: Terminated
• Phase: Phase 3
• First received: January 7, 2009
• Last updated: June 1, 2015
• Start date: December 2008
• Est. completion date: January 2011

Study information

• Verified date: June 2015
• Source: Vifor Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: European Union: European Medicines AgencyGermany: Federal Institute for Drugs and Medical DevicesDenmark: Danish Medicines AgencyFrance: Direction Générale de la SantéIsrael: Ministry of HealthNetherlands: Ministry of Health, Welfare and Sport
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 35
• Est. completion date: January 2011
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• In New York Heart Association (NYHA) II-III functional class due to stable symptomatic chronic heart failure (CHF)

• Left ventricular ejection fraction (LVEF) 40% or lower for patients in NYHA II and 45% or lower in NYHA III

• Screening haemoglobin (Hb) at least 9.5 g/dL but below or equal to 13.5 g/dL (average of 2 haemoglobin concentrations)

• Screening ferritin below 100 µg/L, or below 300 µg/L when transferrin saturation (TSAT) is below 20%

Exclusion Criteria:

• History of acquired iron overload.

• Known active infection, clinically significant bleeding, active malignancy.

• Chronic liver disease and/or screening alanine transaminase (ALT) or aspartate transaminase (AST)

• Anaemia due to reasons other than iron deficiency

• Immunosuppressive therapy or renal dialysis (current or planned within the next 6 months).

• History of erythropoietin, i.v. or oral iron therapy, and blood transfusion in previous 12 weeks and/or such therapy planned within the next 6 months.

• Unstable angina pectoris as judged by the investigator, clinically significant uncorrected valvular disease or left ventricular outflow obstruction, obstructive cardiomyopathy, poorly controlled fast atrial fibrillation or flutter, poorly controlled symptomatic brady- or tachyarrhythmias.

• Acute myocardial infarction or acute coronary syndrome, transient ischaemic attack or stroke within the last 3 months.

• Coronary-artery bypass graft, percutaneous intervention (e.g. cardiac, cerebrovascular, aortic; diagnostic catheters are allowed) or major surgery, including thoracic and cardiac surgery, within the last 3 months.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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).
• 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.

Locations

Country	Name	City	State
Denmark	Research Site	Copenhagen S
Denmark	Research Site	Esbjerg
Denmark	Research Site	Fredericia
Denmark	Research Site	Glostrup
Denmark	Research Site	Hellerup
Denmark	Research Site	Herning
Denmark	Research Site	Hilleroed
Denmark	Research Site	Svendborg
France	Research Site	Boulogne
France	Research Site	Dijon
France	Research Site	Lyon
France	Research Site	Montpellier
France	Research Site	Nantes
France	Research Site	Pontoise
France	Research Site	Rennes
France	Research Site	Saintes
France	Research Site	Strasbourg
Germany	Research Site	Dueren
Germany	Research Site	Frankfurt
Germany	Research Site	Homburg/Saar
Germany	Research Site	Koeln
Germany	Research Site	Mainz
Germany	Research Site	Würzburg
Israel	Research Site	Afula
Israel	Research Site	Ashkelon
Israel	Research Site	Haifa
Israel	Research Site	Holon
Israel	Research Site	Jerusalem
Israel	Research Site	Kfar-Saba
Israel	Research Site	Rehovot
Israel	Research Site	Tel-Aviv
Israel	Research Site	Tel-Hashomer
Israel	Research Site	Zefat
Netherlands	Research Site	Amsterdam
Netherlands	Research Site	Den Bosch
Netherlands	Research Site	Eindhoven
Netherlands	Research Site	Heerenveen
Netherlands	Research Site	Leiden
Netherlands	Research Site	Nieuwegein
Netherlands	Research Site	Tilburg
Netherlands	Research Site	Utrecht

Sponsors (2)

Lead Sponsor	Collaborator
Vifor Inc.	Socar Research SA

Countries where clinical trial is conducted

Denmark,  France,  Germany,  Israel,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The distance covered in six-minute walk tests performed at 4, 12 and 24 weeks		24 weeks	No
Primary	NYHA class assessed at weeks 4, 12 and 24 after the start of study treatment		24 weeks	No
Secondary	Cardiac function assessed by 2D Echo/Doppler cardiography		24 weeks	No
Secondary	Self-reported patient global assessment of treatment		24 weeks	No
Secondary	QOL as assessed by the European Quality of Life - 5 Dimensions and Kansas City Cardi		24 weeks	No