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

April 11, 2017 updated by: National University Hospital, Singapore

Pilot RAndomized Controlled Trial of FerrIC CarboxymaltosE in ASIAns With Heart Failure (the PRACTICE-ASIA-HF) Study

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.

Study Overview

Status

Completed

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Singapore, Singapore, 308433
        • Tan Tock Seng Hospital
      • Singapore, Singapore, 119074
        • National University Heart Centre, Singapore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ferric Carboxymaltose
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.
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.
Other Names:
  • FerInject
Active Comparator: Placebo
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in 6MWT distance over time
Time Frame: 12 weeks
Assess the change in the patient's 6MWT distance over time, from baseline, at 4 weeks, and at 12 weeks.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in QoL as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) and the Visual Analogue Scale (VAS).
Time Frame: 12 weeks
Assess the change in the patient's QoL as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) and the Visual Analogue Scale (VAS) over time, from baseline, at 4 weeks, and at 12 weeks.
12 weeks
Change in NYHA Functional Class
Time Frame: 12 weeks
Assess the change in the patient's NYHA Functional Class over time, from baseline, at 4 weeks, and at 12 weeks.
12 weeks
Rate of HF Hospitalisation
Time Frame: 12 weeks
Assess the change in the patient's Rate of HF Hospitalisation over time, from baseline, at 4 weeks, and at 12 weeks.
12 weeks
Summary of any adverse events reported during the study
Time Frame: 12 weeks
Assess any and all adverse events reported during the study, from baseline to 12 weeks.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Carolyn SP Lam, MBBS, MRCP (UK), National University Heart Centre, Singapore
  • Principal Investigator: Poh Shuan Daniel Yeo, MBBS, MRCP(UK), Tan Tock Seng Hospital
  • Principal Investigator: Tee Joo Yeo, MBBS, MRCP (UK), National University Heart Centre, Singapore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2013

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

August 11, 2013

First Submitted That Met QC Criteria

August 11, 2013

First Posted (Estimate)

August 14, 2013

Study Record Updates

Last Update Posted (Actual)

April 12, 2017

Last Update Submitted That Met QC Criteria

April 11, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 2013/00265
  • IMU/BFA/2012/12 (Other Grant/Funding Number: NUHS IMU Bridging Fund Award 2012)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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