None listed
Conditions
Brief summary
Iron deficiency is commonly seen in congestive heart failure (CHF) in both anaemic and nonanaemic patients. Recent studies have shown that intravenous iron treatment for iron deficiency, with or without anaemia, in congestive heart failure patient improves symptoms, functional capacity and quality of life. This study expand the investigation on the effect of intravenous iron to exercise capacity, echocardiogram changes as well as physical functioning and quality of life in patients with iron deficiency and congestive heart failure.
Interventions
Ferric Carboxymaltose
Subjects who are eligible and agreed to participate in study will be given ferric carboxymaltose for iron deficiency. Ferric carboxymaltose is given intravenously. There will be 2 phases of replacement, namely Corrective phase (week 1 to 10) and Maintenance phase (week 10 to week 24), as detailed below.
Corrective phase: The total iron dose required for iron repletion was calculated at baseline, according to Ganzoni’s formula and the mean of the two hemoglobin values obtai
Ferric Carboxymaltose Subjects who are eligible and agreed to participate in study will be given ferric carboxymaltose for iron deficiency. Ferric carboxymaltose is given intravenously. There will be 2 phases of replacement, namely Corrective phase (week 1 to 10) and Maintenance phase (week 10 to week 24), as detailed below. Corrective phase: The total iron dose required for iron repletion was calculated at baseline, according to Ganzoni’s formula and the mean of the two hemoglobin values obtained during the screening period. Dosing frequency is weekly with maximum dose being 1000mg per week until total iron dose administered. Maintenance phase: Reassessment on iron status, haemoglobin and iron-repletion dose performed on 4 weekly bases from week 10 onwards until week 24. Maintenance dose is determined by Ganzoni’s formula. Dosing frequency is on as required basis with maximum dose being 1000mg per week. Adherence is monitored by attendance to day ward for Ferric Carboxymaltose intravenous infusion.
Sponsors
Haematology Department, Fremantle Hospital
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female 18 years of age or above 2. Congestive heart failure of New York Heart Association (NYHA) functional class II or III, defined by left ventricular ejection fraction of 40% or less (for patients with NYHA class II) or 45% or less (for NYHA class III) 3. Iron deficiency, defined by ferritin level <100 microg per liter or between 100 and 299 microg per liter, if the transferrin saturation is <20% 4. Haemoglobin level at the screening less than 135 g per liter 5. Written informed consent
Exclusion criteria
1. Acute Heart Failure 2. Clinically significant Chronic Obstructive Pulmonary Disease, defined as moderate or worse on GOLD grading 3. Clinically significant liver impairment, defined as Child-Pugh class B or C 4. Clinically significant renal impairment, defined as Chronic Kidney Disease stage 5 5. Presence of other condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
Outcome results
None listed