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

NCT01922479 | Completed Phase 4 DMC

• 2 other identifiers: 2013/00265IMU/BFA/2012/12
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Heart Failure; Anemia; Iron Deficiency

Keywords

Heart Failure; Anemia; Iron Deficiency; Ferric Carboxymaltose; Asian

Outcome Measures

Primary Outcomes (1)

• Change in 6MWT distance over time

  Assess the change in the patient's 6MWT distance over time, from baseline, at 4 weeks, and at 12 weeks.

  12 weeks

Secondary Outcomes (4)

• Change in QoL as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) and the Visual Analogue Scale (VAS).

  12 weeks

• Change in NYHA Functional Class

  12 weeks

• Rate of HF Hospitalisation

  12 weeks

• Summary of any adverse events reported during the study

  12 weeks

Study Arms (2)

Ferric Carboxymaltose

EXPERIMENTAL

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.

Drug: Ferric Carboxymaltose

Placebo

ACTIVE COMPARATOR

20mls intravenous Normal Saline (0.9%), given as slow bolus injection over 15 minutes. Allowed to take oral iron supplements in usual clinical doses as prescribed clinically by attending physicians.

Drug: Placebo

Interventions

Ferric Carboxymaltose DRUG

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.

Also known as: FerInject

Ferric Carboxymaltose

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National University Hospital, Singapore: lead
• National University Heart Centre, Singapore: collaborator
• Tan Tock Seng Hospital: collaborator

Study Sites (2)

National University Heart Centre, Singapore

Singapore, Singapore, 119074, Singapore

Location

Tan Tock Seng Hospital

Singapore, Singapore, 308433, Singapore

Location

MeSH Terms

Conditions

Heart Failure; Anemia; Iron Deficiencies

Interventions

ferric carboxymaltose

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Carolyn SP Lam, MBBS, MRCP (UK)

  National University Heart Centre, Singapore

  STUDY CHAIR

• Poh Shuan Daniel Yeo, MBBS, MRCP(UK)

  Tan Tock Seng Hospital

  PRINCIPAL INVESTIGATOR

• Tee Joo Yeo, MBBS, MRCP (UK)

  National University Heart Centre, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2013
• First Posted: August 14, 2013
• Study Start: September 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 12, 2017

Record last verified: 2017-04

Locations

SG (2)