Anaemia, Chronic Heart Failure, Iron Deficiency, Iron Deficiency Anemia
Conditions
Keywords
Chronic Heart Failure, Iron deficiency, Iron deficiency anaemia, Anaemia, Heart disease
Brief summary
This study is designed to evaluate the efficacy of Ferinject® in improving symptoms of CHF in patients with iron deficiency. Analyses will focus both on subjective and objective measures. Furthermore, the tolerability and safety of Ferinject® treatment will be evaluated.
Interventions
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).
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.
Sponsors
Syneos Health
ClinStar, LLC
Vifor Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Self-reported patient global assessment (PGA) and NYHA functional status 24 weeks after initiation of therapy | 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Key secondary objectives (efficacy): Exercise tolerance (6-minute walk test distance). Further secondary objectives(efficacy): Health related quality of life, resource use and costs associated with the treatment, safety and tolerability | 24 weeks |
Countries
Argentina, Germany, Greece, Italy, Norway, Poland, Romania, Russia, Spain, Ukraine
Outcome results
None listed