Pilot Study of Ferric Carboxymaltose to Treat Iron Deficiency in Asians With Heart Failure

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Heart failure (HF) is a major global public health issue which also affects Asia. Data from the National Registry of Disease in Singapore shows a 9.4% rise in HF admissions in public hospitals from 2008 to 2009 (4140 to 4530). Anaemia (low blood Haemoglobin level) is a common problem occurring in HF, ranging from 14% to 56% in outpatient registries and clinical trials. Anaemia exacerbates the basic symptoms of HF of dyspnea and exercise intolerance, thereby reducing quality of life (QoL). However, recent approaches aimed at improving and normalizing Haemoglobin have been unsuccessful.Novel approaches are required to address this problem. Iron deficiency (ID) is a well-understood cause of anaemia. ID without overt anaemia may be present in HF patients. A recent study by Jankowska et al published in 2010 of 546 HF patients showed a 37% prevalence of ID, regardless of Haemoglobin level. This was associated with worse outcomes including impaired exercise capacity. The presence of ID indicates a higher likelihood of deteriorating and dying early. A landmark study published in the New England Journal of Medicine (The Ferinject Assessment in Patients with Iron Deficiency and Chronic Heart Failure (FAIR-HF) study) showed that HF patients who were treated with IV iron in the form of Ferric Carboxymaltose (FCM) had better outcomes, including improved exercise capacity, overall function, and quality of life.

There is a lack of contemporary data on ID in HF patients in Asia, including data on treatment with this novel IV iron FCM.

Hypothesis We hypothesise that treating ID in HF patients in Asia using FCM will improve outcomes including exercise capacity, quality of life, overall functional status, and the need to be hospitalised for complications arising from HF.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National University Hospital, Singapore
• Collaborators: National University Heart Centre, Singapore; Tan Tock Seng Hospital
• Treatments: Ferric Compounds; Iron

Criteria

Inclusion Criteria:

• Patients hospitalized for HF (regardless of LVEF)

• Capable of completing the 6MWT

• Screening TSAT <20%, Serum Ferritin <300 ng/mL and Hb≤14 g/dL

• At least 21 years of age

• Written informed consent.

Exclusion Criteria:

• Acute coronary syndrome

• Acute valvular heart dysfunction

• Known sensitivity to FCM

• IV iron therapy and/or blood transfusion in the 4 weeks prior to randomisation

• Body weight ≤35 kg

• Active bacterial infection

• Haemochromatosis or other iron storage disorder

• Serious medical condition, emergency condition, uncontrolled systemic disease or any other medical condition that, in the judgment of the Investigator, prohibits the patient from participating or potentially completing the study

• Planned participation in any other interventional study or having received trial medication in the context of a clinical trial within the last 4 weeks prior to participating in this trial.