Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000154606
Ethics application status
Not yet submitted
Date submitted
22/01/2014
Date registered
10/02/2014
Date last updated
10/02/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Iron replacement for congestive heart failure with iron deficiency
Scientific title
In patients with congestive heart failure and iron deficiency, can iron replacement improve symptoms of heart failure?
Secondary ID [1] 283960 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Congestive Heart Failure 290989 0
Iron deficiency 290990 0
Condition category
Condition code
Cardiovascular 291332 291332 0 0
Other cardiovascular diseases
Blood 291333 291333 0 0
Other blood disorders
Diet and Nutrition 291356 291356 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ferric Carboxymaltose
Subjects who are eligible and agreed to participate in study will be given ferric carboxymaltose for iron deficiency. Ferric carboxymaltose is given intravenously. There will be 2 phases of replacement, namely Corrective phase (week 1 to 10) and Maintenance phase (week 10 to week 24), as detailed below.
Corrective phase: The total iron dose required for iron repletion was calculated at baseline, according to Ganzoni’s formula and the mean of the two hemoglobin values obtained during the screening period. Dosing frequency is weekly with maximum dose being 1000mg per week until total iron dose administered.
Maintenance phase: Reassessment on iron status, haemoglobin and iron-repletion dose performed on 4 weekly bases from week 10 onwards until week 24. Maintenance dose is determined by Ganzoni’s formula. Dosing frequency is on as required basis with maximum dose being 1000mg per week.
Adherence is monitored by attendance to day ward for Ferric Carboxymaltose intravenous infusion.
Intervention code [1] 288648 0
Treatment: Drugs
Comparator / control treatment
No treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291318 0
To assess change in patient symptoms through Patient Global Assessment
Timepoint [1] 291318 0
6 months post iron replacement
Primary outcome [2] 291319 0
To assess change in patient symptoms through New York Heart Association functional class
Timepoint [2] 291319 0
6 months post iron replacement
Primary outcome [3] 291320 0
To assess change in patient cardiac function with left ventricular ejection fraction on transthoracic echocardiogram
Timepoint [3] 291320 0
6 months post iron replacement
Secondary outcome [1] 306523 0
To assess change in patient symptoms through Troponin-I using chemiluminescence immunoassay
Timepoint [1] 306523 0
6 months post iron replacement
Secondary outcome [2] 306524 0
To assess change in patient symptoms through N-terminal pro Brain natriuretic peptide using chemiluminescence immunoassay
Timepoint [2] 306524 0
6 months post iron replacement
Secondary outcome [3] 306525 0
To assess change in patient symptoms through 6 minutes walk test
Timepoint [3] 306525 0
6 months post iron replacement
Secondary outcome [4] 306526 0
To assess change in patient cardiac function with Peak VO2 by getting patient to do incremental exercise test on cycle ergometer.
Timepoint [4] 306526 0
6 months post iron replacement

Eligibility
Key inclusion criteria
1. Male or female 18 years of age or above
2. Congestive heart failure of New York Heart Association (NYHA) functional class II or III, defined by left ventricular ejection fraction of 40% or less (for patients with NYHA class II) or 45% or less (for NYHA class III)
3. Iron deficiency, defined by ferritin level <100 microg per liter or between 100 and 299 microg per liter, if the transferrin saturation is <20%
4. Haemoglobin level at the screening less than 135 g per liter
5. Written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Acute Heart Failure
2. Clinically significant Chronic Obstructive Pulmonary Disease, defined as moderate or worse on GOLD grading
3. Clinically significant liver impairment, defined as Child-Pugh class B or C
4. Clinically significant renal impairment, defined as Chronic Kidney Disease stage 5
5. Presence of other condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/03/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 1989 0
Fremantle Hospital and Health Service - Fremantle

Funding & Sponsors
Funding source category [1] 288592 0
Hospital
Name [1] 288592 0
Fremantle Hospital
Country [1] 288592 0
Australia
Primary sponsor type
Hospital
Name
Haematology Department, Fremantle Hospital
Address
PO Box 480, Fremantle, 6959 WA
Country
Australia
Secondary sponsor category [1] 287299 0
None
Name [1] 287299 0
Address [1] 287299 0
Country [1] 287299 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 290455 0
WA HEALTH ETHICS
Ethics committee address [1] 290455 0
Ethics committee country [1] 290455 0
Australia
Date submitted for ethics approval [1] 290455 0
13/01/2014
Approval date [1] 290455 0
Ethics approval number [1] 290455 0
14/6

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45786 0
Prof Michael F Leahy
Address 45786 0
PO Box 480
Fremantle Hospital
Fremantle 6959 WA
Country 45786 0
Australia
Phone 45786 0
+618 94312886
Fax 45786 0
Email 45786 0
[email protected]
Contact person for public queries
Name 45787 0
Hun Chuah
Address 45787 0
PO Box 480
Fremantle Hospital
Fremantle 6959 WA
Country 45787 0
Australia
Phone 45787 0
+618 94312886
Fax 45787 0
Email 45787 0
[email protected]
Contact person for scientific queries
Name 45788 0
Hun Chuah
Address 45788 0
PO Box 480
Fremantle Hospital
Fremantle 6959 WA
Country 45788 0
Australia
Phone 45788 0
+618 94312886
Fax 45788 0
Email 45788 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.