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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2013 by National University Hospital, Singapore
Sponsor:
Collaborators:
National University Heart Centre, Singapore
Tan Tock Seng Hospital
Information provided by (Responsible Party):
National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT01922479
First received: August 11, 2013
Last updated: NA
Last verified: August 2013
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Heart Failure
Anemia
Iron Deficiency
Drug: Ferric Carboxymaltose
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot RAndomized Controlled Trial of FerrIC CarboxymaltosE in ASIAns With Heart Failure (the PRACTICE-ASIA-HF) Study

Resource links provided by NLM:


Further study details as provided by National University Hospital, Singapore:

Primary Outcome Measures:
  • Change in 6MWT distance over time [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Assess the change in the patient's 6MWT distance over time, from baseline, at 4 weeks, and at 12 weeks.


Secondary Outcome Measures:
  • Change in QoL as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) and the Visual Analogue Scale (VAS). [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    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.

  • Change in NYHA Functional Class [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Assess the change in the patient's NYHA Functional Class over time, from baseline, at 4 weeks, and at 12 weeks.

  • Rate of HF Hospitalisation [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Assess the change in the patient's Rate of HF Hospitalisation over time, from baseline, at 4 weeks, and at 12 weeks.

  • Summary of any adverse events reported during the study [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Assess any and all adverse events reported during the study, from baseline to 12 weeks.


Estimated Enrollment: 50
Study Start Date: August 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: 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.
Other Names:
  • Ferric Carboxymaltose
  • 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.
Drug: Placebo
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.

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.

  Eligibility

Ages Eligible for Study:   21 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01922479

Contacts
Contact: Carolyn SP Lam, MBBS, MRCP (UK) +65-67795555 Carolyn_Lam@nuhs.edu.sg
Contact: Poh Shuan Daniel Yeo, MBBS, MRCP (UK) +65-63577831 DanielYeo@hotmail.com

Locations
Singapore
National University Heart Centre, Singapore Not yet recruiting
Singapore, Singapore, 119074
Contact: Carolyn SP Lam, MBBS, MRCP (UK)    +65-67795555      
Contact: Tee Joo Yeo, MBBS, MRCP (UK)    +65-67795555      
Principal Investigator: Carolyn SP Lam, MBBS, MRCP (UK)         
Principal Investigator: Tee Joo Yeo, MBBS, MRCP (UK)         
Tan Tock Seng Hospital Not yet recruiting
Singapore, Singapore, 308433
Contact: Poh Shuan Daniel Yeo, MBBS, MRCP (UK)    +65-67795555      
Principal Investigator: Poh Shuan Daniel Yeo, MBBS, MRCP (UK)         
Sub-Investigator: Seet Yoong Loh, MBBS, MRCP (UK)         
Sponsors and Collaborators
National University Hospital, Singapore
National University Heart Centre, Singapore
Tan Tock Seng Hospital
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
  More Information

No publications provided

Responsible Party: National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT01922479     History of Changes
Other Study ID Numbers: 2013/00265, IMU/BFA/2012/12
Study First Received: August 11, 2013
Last Updated: August 11, 2013
Health Authority: Singapore: Domain Specific Review Boards
Singapore: Health Sciences Authority
Singapore: Singapore Clinical Research Institute

Keywords provided by National University Hospital, Singapore:
Heart Failure
Anemia
Iron Deficiency
Ferric Carboxymaltose
Asian

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Heart Failure
Anemia
Anemia, Hypochromic
Cardiovascular Diseases
Heart Diseases
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Ferric Compounds
Hematinics
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014