Clinical trial NCT00821717: EFfect of Ferric Carboxymaltose on exercIse CApacity and Cardiac Function in Patients With Iron deficiencY and Chronic Heart Failure
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Chronic Heart Failure
Iron Deficiency
Iron Deficiency Anemia
Anaemia
Keywords: Chronic Heart Failure
Iron deficiency
Iron deficiency anaemia
Anaemia
Heart disease
Lead sponsor: Vifor Pharma
Sponsor class: INDUSTRY
Collaborators: name: Socar Research SA
First posted: 2009-01-13
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: The distance covered in six-minute walk tests performed at 4, 12 and 24 weeks
timeFrame: 24 weeks
measure: NYHA class assessed at weeks 4, 12 and 24 after the start of study treatment
timeFrame: 24 weeks
Secondary outcomes:
measure: Cardiac function assessed by 2D Echo/Doppler cardiography
timeFrame: 24 weeks
measure: Self-reported patient global assessment of treatment
timeFrame: 24 weeks
measure: QOL as assessed by the European Quality of Life - 5 Dimensions and Kansas City Cardi
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Copenhagen S
country: Denmark
facility: Research Site
city: Esbjerg
country: Denmark
facility: Research Site
city: Fredericia
country: Denmark
facility: Research Site
city: Glostrup
country: Denmark
facility: Research Site
city: Hellerup
country: Denmark
facility: Research Site
city: Herning
country: Denmark
facility: Research Site
city: Hilleroed
country: Denmark
facility: Research Site
city: Svendborg
country: Denmark
facility: Research Site
city: Boulogne
country: France
facility: Research Site
city: Dijon
country: France
facility: Research Site
city: Lyon
country: France
facility: Research Site
city: Montpellier
country: France
facility: Research Site
city: Nantes
country: France
facility: Research Site
city: Pontoise
country: France
facility: Research Site
city: Rennes
country: France
facility: Research Site
city: Saintes
country: France
facility: Research Site
city: Strasbourg
country: France
facility: Research Site
city: Dueren
country: Germany
facility: Research Site
city: Frankfurt
country: Germany
facility: Research Site
city: Homburg/Saar
country: Germany
facility: Research Site
city: Koeln
country: Germany
facility: Research Site
city: Mainz
country: Germany
facility: Research Site
city: Würzburg
country: Germany
facility: Research Site
city: Afula
country: Israel
facility: Research Site
city: Ashkelon
country: Israel
facility: Research Site
city: Haifa
country: Israel
facility: Research Site
city: Holon
country: Israel
facility: Research Site
city: Jerusalem
country: Israel
facility: Research Site
city: Kfar-Saba
country: Israel
facility: Research Site
city: Rehovot
country: Israel
facility: Research Site
city: Tel-Aviv
country: Israel
facility: Research Site
city: Tel-Hashomer
country: Israel
facility: Research Site
city: Zefat
country: Israel
facility: Research Site
city: Amsterdam
country: Netherlands
facility: Research Site
city: Den Bosch
country: Netherlands
facility: Research Site
city: Eindhoven
country: Netherlands
facility: Research Site
city: Heerenveen
country: Netherlands
facility: Research Site
city: Leiden
country: Netherlands
facility: Research Site
city: Nieuwegein
country: Netherlands
facility: Research Site
city: Tilburg
country: Netherlands
facility: Research Site
city: Utrecht
country: Netherlands
facility: Research Site
Study officials:
affiliation: Sheba Medical Center, Tel-Hashomer 52621, Israel
name: Michael Motro, MD, FACC
role: STUDY_CHAIR
References: