Ambulatory patients with stable symptomatic chronic CHF (congestive heart failure) and iron deficiency. MedDRA version: 9.1 Level: LLT Classification code 10008908 Term: Chronic heart failure MedDRA version: 9.1 Level: LLT Classification code 10002062 Term: Anaemia iron deficiency
Conditions
Interventions
Trade Name: Ferinject
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Ferric carboxymaltose
Current Sponsor code: VIT-45
Other descriptive name: See IMPD, page 5
Concentration unit: m
Sponsors
Vifor Pharma - Vifor (International) AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: At least 18 years of age who have provided written informed consent; In NYHA (New York Heart Association) functional class II or III, Ambulatory and capable of performing a 6-minute walk test; Treated for CHF (congestive heart failure) during at least one hospital, emergency room or acute clinic admission within the last 24 months or brain natriuretic peptide (BNP) = 100 pg/ml or N-terminal pro-hormone brain natriuretic peptide (NT-proBNP) = 400 pg/ml, not older than 8 weeks when study treatment is started; Currently treated for CHF for at least 4 weeks with the same combination of at least two of the following: (a) diuretic, (b) beta-blocker (including carvedilol), (c) ACE (angiotensin converting enzyme inhibitor) or ARB (angiotensin II receptor blocker); Treated during the last 2 weeks with the same dose of drugs given for CHF (dose changes of diuretics are allowed); Resting cuff blood pressures = to 160 mm Hg systolic and = 100 mm Hg diastolic (at the disappearance of sounds, Korotkoff phase V); LVEF (left-ventricular ejection fraction) = 40% assessed locally by 2D Echocardiography; Screening Hb (haemoglobin) value = 9.5 g/dL (5.9 mmol/L), and = 13.5 g/dL (8.4 mmol/L). Screening ferritin below 100 µg/L (224.7 pmol/l), or below 300 µg/L (674.1 pmol/l) when TSAT (transferrin saturation) is below 20%; Use of adequate contraceptive methods for women of childbearing potential. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Unstable angina pectoris; Walking distance limited by intermittent claudication; Significant valvular disease or left ventricular outflow obstruction; Poorly controlled rapid atrial fibrillation or flutter, symptomatic brady- or tachyarrhythmia; Chronic liver disease; Active infection, clinically significant bleeding, life expectancy reduced by malignancy or known HIV/AIDS (human immunodeficiency virus/acquired immune deficiency syndrome); Anaemia due to reasons other than iron deficiency (e.g. haemoglobinopathy); On immunosuppressive therapy or renal dialysis; Pregnant or lactating; Hospitalisation, emergency room or acute clinic admission for CHF within the last 2 weeks; AMI (acute myocardial infarction) or CVA (cerebrovascular accident) within the last 12 weeks; PCI (percutaneous coronary intervention), CABG (coronary artery bypass graft), major surgery, CRT, ICD or ICD-CRT implantation within the last 12 weeks (diagnostic angiography is allowed); History of acquired iron overload or hypersensitivity to FCM (ferric carboxymaltose) or to any of its excipients; Erythropoiesis Stimulating agents (ESAs), i.v. or blood transfusion administered within the last 12 weeks, or oral iron therapy within the last 30 days; Participation in another clinical trial within the last 30 days; Inadequate quality for central analysis of locally recorded 2D Echo/Doppler cardiograms; Screening ALT (alanine transaminase) or AST (aspartate aminotransferase) > three times the local upper limit of normal; CRP (C-reactive protein) >20 mg/L; Immunosuppressive therapy, renal dialysis, EPO, i.v. or oral iron therapy, or blood transfusion planned; Present abuse of alcohol or drugs; Anticipated participation in another trial during this trial; Inability to fully comprehend and/or comply with trial procedures in the investigator’s opinion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this trial is to assess, relative to placebo, the effects on the evolution of exercise capacity (i.e. 6-minute walk test) and symptomatic status (i.e. New York Heart Association classification) of the addition of intravenous iron treatment with FCM (ferric carboxymaltose) to the basic regimen of ambulatory patients with stable symptomatic chronic CHF (congestive heart failure) and iron deficiency.;Secondary Objective: Secondary objectives are to evaluate the effect of intravenous FCM compared to placebo on: 1. Evolution from baseline of cardiac function parameters as assessed by 2D Echo/Doppler cardiography 4, 12 and 24 weeks after start of study treatment. 2. Self-reported patient global assessment (PGA) of treatment at 4, 12 and 24 weeks after start of study treatment. 3. Health related quality of life (HRQoL) as assessed by the EQ-5D (European quality of life – 5 dimensions) and KCCQ (Kansas City Cardiomyopathy Questionnaire) self-administered questionnaires 4, 12 and 24 weeks after start of study treatment.;Primary end point(s): In accordance with this trial’s primary objective, the two co-primary outcomes are: 1. Evolution from baseline of the distance covered during 6MWTs (6-minute walk tests) performed 4, 12 and 24 weeks after the start of study treatment. 2. Evolution from baseline in NYHA (New York Heart Association) functional class assessments performed at 4, 12 and 24 weeks after the start of study treatment. | — |
Countries
Denmark, Germany, Netherlands
Outcome results
None listed