Pilot Study of Ferric Carboxymaltose to Treat Iron Deficiency in Asians With Heart Failure
Condition: Heart Failure; Anemia; Iron Deficiency
MeSH terms: Heart Failure; Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      Heart failure (HF) is a major global public health issue which also affects Asia. Singapore
      National Registry of Disease data shows a 9.4% rise in public hospital HF admissions from
      2008 to 2009 (4140 to 4530). Anaemia (low blood Haemoglobin level) is a common co-morbidity
      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 (STAMINA-HeFT, RED-HF).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. The study by Jankowska (2010) of 546 systolic HF
      patients had a 37% prevalence of ID, regardless of Haemoglobin level. This was associated
      with reduced peak oxygen consumption, high ventilatory response, impaired exercise capacity,
      and depressive symptoms in HF patients. ID was a strong independent predictor of death, heart
      transplantation, and poor clinical outcome in chronic HF.The Ferinject Assessment in Patients
      with Iron Deficiency and Chronic Heart Failure (FAIR-HF) study showed significant improvement
      in 6MWT, NYHA class, and overall QoL score in HF patients treated with IV iron in the form of
      Ferric Carboxymaltose (FCM).Unpublished preliminary data from the ongoing Nation-wide
      Singapore study on Heart Failure (SHOP) indicates that the observed point prevalence of ID is
      approximately 60% with a significant and direct correlation with exercise performance.To
      date, no studies exist of FCM in an Asian HF population. We hypothesise that IV Iron
      repletion therapy using FCM in Asian patients with HF and ID will improve outcomes including
      exercise capacity (measured by 6MWT), quality of life (measured by the Kansas City
      Cardiomyopathy Questionnaire (KCCQ amp; VAS), NYHA functional class, and rate of HF
      hospitalization.

      Primary Aim To determine the effect of IV iron repletion therapy compared to placebo on
      exercise capacity change as assessed by the 6MWT at the 4th and 12th week after
      administration of IV FCM in subjects with recent acutely decompensated heart failure and iron
      deficiency.

      Secondary Aims To assess the effect of IV FCM compared with placebo on change in QoL
      assessments (KCCQ amp; VAS).To assess the effect of IV FCM compared with placebo on change in
      NYHA Functional Class.To assess the effect of IV FCM compared with placebo on the rate of HF
      Hospitalization.To assess the safety and tolerability of IV FCM compared to placebo.

      Hypothesis We hypothesise that IV Iron repletion therapy using FCM in patients with HF and ID
      will improve outcomes including exercise capacity (measured by 6MWT), quality of life
      (measured by KCCQ amp; VAS), NYHA functional class, and rate of HF hospitalization.
    

Intervention name(s): Ferric Carboxymaltose; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1000mg intravenous Ferric Carboxymaltose, given as undiluted slow bolus injection over 15 minutes. Allowed to take concomitant oral iron supplements in usual clinical doses as prescribed clinically by attending physicians.; 20mls intravenous Normal Saline (0.9%), given as slow bolus injection over 15 minutes. Allowed to take concomitant oral iron supplements in usual clinical doses as prescribed clinically by attending physicians.
Other intervention name(s): FerInject
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Heart Failure; Anemia; Iron Deficiency; Ferric Carboxymaltose; Asian