- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01922479
Pilot Study of Ferric Carboxymaltose to Treat Iron Deficiency in Asians With Heart Failure (PRACTICEASIAHF)
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
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Singapore, Singapore, 308433
- Tan Tock Seng Hospital
-
Singapore, Singapore, 119074
- National University Heart Centre, Singapore
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
|
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
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
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
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
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on Heart Failure
-
Manipal UniversityUnknownHeart Failure | Decompensated Heart Failure | Acute Heart Failure | Diastolic Heart Failure | Systolic Heart FailureIndia
-
Tufts Medical CenterMetro West Medical CenterCompletedCongestive Heart Failure | Diastolic Heart Failure | Systolic Heart FailureUnited States
-
Abbott Medical DevicesCompletedHeart Failure | Heart Failure, Diastolic | Heart Failure, Systolic | Heart Failure NYHA Class II | Heart Failure NYHA Class III | Heart Failure With Reduced Ejection Fraction | Heart Failure NYHA Class IV | Heart Failure With Normal Ejection Fraction | Heart Failure; With Decompensation | Heart Failure...United States, Canada
-
VA Eastern Colorado Health Care SystemNational Institute on Aging (NIA)CompletedHeart Failure | Heart Failure, Diastolic | Heart Failure, Systolic | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection Fraction | Heart Failure; With Decompensation | Heart Failure,Congestive | Heart Failure AcuteUnited States
-
Lancaster General HospitalLouise von Hess Medical Research InstituteEnrolling by invitationDiastolic Heart FailureUnited States
-
University Hospital, MontpellierCompletedHeart Failure | Diastolic Heart Failure | Systolic Heart Failure Stage CFrance
-
Wake Forest UniversityNational Institute on Aging (NIA)CompletedHeart Failure, Congestive | Diastolic Heart FailureUnited States
-
Wake Forest UniversityCompletedHeart Failure, Congestive | Heart Failure With Preserved Ejection Fraction
-
US Department of Veterans AffairsCompleted
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR); Duke University; St. Paul's Hospital... and other collaboratorsActive, not recruitingHeart Diseases | Heart Failure | Transplant; Failure, Heart | Heart Transplant Failure and Rejection | Heart Failure,Congestive | Transplant FailureCanada, United States
Clinical Trials on Ferric Carboxymaltose
-
Sichuan Huiyu Pharmaceutical Co., LtdThe First Hospital of Jilin University; Suzhou Guochen Biotek Co., Ltd.; Boji... and other collaboratorsActive, not recruitingBioequivalence Study of Ferric Carboxymaltose Injection in Participants With Iron Deficiency AnaemiaIron Deficiency | AnaemiaChina
-
Hasselt UniversityZiekenhuis Oost-LimburgCompleted
-
The Catholic University of KoreaUnknownKnee Osteoarthritis | Total Knee Arthroplasty | Postoperative Anemia
-
The Catholic University of KoreaUnknownKnee Osteoarthritis | Total Knee Arthroplasty | Postoperative Anemia
-
Charite University, Berlin, GermanyUniversity of GöttingenUnknownHeart Failure | Iron-deficiencyGermany
-
St Joseph University, Beirut, LebanonSaint-Joseph University; Vifor PharmaCompletedAnemia, Iron DeficiencyLebanon
-
Istanbul UniversityRecruitingAnemia | Hip Fractures | Complication,PostoperativeTurkey
-
Vifor PharmaTerminatedIron-Deficiency AnemiaFrance, Greece
-
American Regent, Inc.Completed
-
University of ZurichTerminated