Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000990426
Ethics application status
Approved
Date submitted
26/08/2025
Date registered
8/09/2025
Date last updated
8/09/2025
Date data sharing statement initially provided
8/09/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Iron Infusion Post Cardiac Surgery - A Randomised Controlled Trial (Iron Heart)
Scientific title
The impact of iron infusion after cardiac surgery on quality of life: A Randomised Controlled Trial (Iron Heart)
Secondary ID [1] 315219 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anaemia 338666 0
Condition category
Condition code
Blood 334957 334957 0 0
Anaemia
Cardiovascular 335058 335058 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Trial is evaluating if the administration of parenteral iron supplement in post-operative, anaemic, cardiac surgery patients result in improved self-reported quality of life measures. Participants will be randomised to receive either intravenous ferric carboxymaltose 1000mg or placebo. Participants randomised to the treatment arm will be administered intravenous ferric carboxymaltose 1000mg once on day 4 post-surgery prior to discharge. All participants will be administered a quality-of-life questionnaire (EQ-5D-5L) on day 4 post-surgery prior to the infusion, and week 6 post-surgery. Strategies used to assess or monitor fidelity to the intervention include an audit of hospital notes and pharmacy accountability log by a trial coordinator not involved in the study.
Intervention code [1] 331829 0
Treatment: Drugs
Comparator / control treatment
Participants randomised to the control arm will be administered the intravenous placebo (Normal Saline 0.9% 250ml) on day 4 post-surgery, prior to discharge. Participants will be administered a quality-of-life questionnaire (EQ-5D-5L) on day 4 post-surgery prior to the infusion, and week 6 post-surgery.
Control group
Placebo

Outcomes
Primary outcome [1] 342587 0
The EQ-5D-5L quality of life questionnaire score
Timepoint [1] 342587 0
Primary timepoints: Day 4 post-surgery and Week 6 post-surgery Primary endpoint: Week 6 post-surgery
Secondary outcome [1] 451429 0
Composite secondary outcome: Measures of iron stores (Haemoglobin, Plasma ferritin concentration, Plasma iron concentration, Full Blood Examination (FBE))
Timepoint [1] 451429 0
Day 4, Week 2, Week 4, and Week 6 post-surgery
Secondary outcome [2] 451430 0
Discharge destination post cardiac surgery
Timepoint [2] 451430 0
At time of hospital discharge
Secondary outcome [3] 451431 0
Hospital re-admission
Timepoint [3] 451431 0
Week 6
Secondary outcome [4] 451432 0
Composite secondary outcome: Post-operative cardiac arrhythmia and infection
Timepoint [4] 451432 0
At time of hospital discharge, and at Week 6

Eligibility
Key inclusion criteria
• Age 18+ years
• Cardiac surgery patients with a post-operative day-4 haemoglobin of less than 100 g/L will be eligible for inclusion.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Have a history of haemochromatosis or polycythemia vera
• Have a body weight of less than 50 kg
• Patients with haemodialysis-dependent chronic kidney disease

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The sample size was calculated based on the Minimally Important Difference (MID) of the EQ-5D-5L derived utility scores. A sample size of 64 patients, with 32 patients per arm will ensure detection of this difference with 80% power at a level of significance of 0.05. A ~10% drop out rate will be assumed. To account for those potential withdrawals, a total of 80 participants will be recruited to the trial, 40 participants per trial arm.

Inferential statistical analysis, including but not limited to paired t-tests and non-parametric tests, will be used to compare and determine statistically significant change in primary and secondary outcome measures following placebo / iron infusions. A p-value < 0.05 will be considered the threshold for statistical significance. EQ-5D-5L has a known minimally important difference (MID) of 0.01 – 0.4117. Specifically, statistically significant change will be determined for pre- and post-operative intervention of:
• EQ-5D-5L
• Haemoglobin
• Plasma ferritin concentrations
• Plasma iron concentrations
• FBE

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
12/09/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 28371 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 44592 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 319786 0
Hospital
Name [1] 319786 0
St Vincent's Hospital Melbourne
Country [1] 319786 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital Melbourne
Address
Country
Australia
Secondary sponsor category [1] 322299 0
None
Name [1] 322299 0
Address [1] 322299 0
Country [1] 322299 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318346 0
St Vincent’s Hospital Human Research Ethics Committee
Ethics committee address [1] 318346 0
Ethics committee country [1] 318346 0
Australia
Date submitted for ethics approval [1] 318346 0
06/05/2025
Approval date [1] 318346 0
22/07/2025
Ethics approval number [1] 318346 0

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

Contacts
Principal investigator
Name 143882 0
Dr Joshua De Bono
Address 143882 0
St Vincent's Hospital Melbourne - 41 Victoria Parade Pde, Fitzroy, VIC 3065
Country 143882 0
Australia
Phone 143882 0
+61 3 9231 1618
Fax 143882 0
Email 143882 0
[email protected]
Contact person for public queries
Name 143883 0
Monique Farmer
Address 143883 0
St Vincent's Hospital Melbourne - 41 Victoria Parade Pde, Fitzroy, VIC 3065
Country 143883 0
Australia
Phone 143883 0
+61 3 9231 1618
Fax 143883 0
Email 143883 0
[email protected]
Contact person for scientific queries
Name 143884 0
Monique Farmer
Address 143884 0
St Vincent's Hospital Melbourne - 41 Victoria Parade Pde, Fitzroy, VIC 3065
Country 143884 0
Australia
Phone 143884 0
+61 3 9231 1618
Fax 143884 0
Email 143884 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.