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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03037931




Registration number
NCT03037931
Ethics application status
Date submitted
25/01/2017
Date registered
31/01/2017

Titles & IDs
Public title
Randomized Placebo-controlled Trial of FCM as Treatment for Heart Failure With Iron Deficiency / and Sub-Study
Scientific title
A Randomized, Double-Blind, Placebo- Controlled Study to Investigate the Efficacy and Safety of Injectafer® (Ferric Carboxymaltose) as Treatment for Heart Failure With Iron Deficiency /and Sub-Study
Secondary ID [1] 0 0
1VIT15043
Universal Trial Number (UTN)
Trial acronym
HEART-FID
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Iron-deficiency 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Blood 0 0 0 0
Anaemia
Diet and Nutrition 0 0 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ferric Carboxymaltose
Treatment: Drugs - Placebo

Active comparator: Ferric Carboxymaltose - Ferric Carboxymaltose 2 doses intravenously of 15mg/kg to a maximum individual dose of 750mg 7 days apart and a maximum combined dose of 1500mg - repeated every 6 months as indicated by the results of iron indices.

Placebo comparator: Placebo - Normal saline 15ml - 2 doses 7 days apart repeated every 6 months.


Treatment: Drugs: Ferric Carboxymaltose
Intravenous Iron

Treatment: Drugs: Placebo
Normal Saline Solution
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Deaths
Timepoint [1] 0 0
1 year
Primary outcome [2] 0 0
Number of Hospitalizations for Heart Failure
Timepoint [2] 0 0
1 year
Primary outcome [3] 0 0
Change in 6MWT (Six Minute Walk Test) Distance
Timepoint [3] 0 0
6 months

Eligibility
Key inclusion criteria
1. Adult (=18 years of age) able to provide signed, written informed consent.
2. Stable heart failure (NYHA II-IV) on maximally-tolerated background therapy (as determined by the site Principle Investigator) for at least 2 weeks prior to randomization.
3. Able and willing to perform a six-minute walk test (6MWT) at the time of randomization.
4. Reduced left ventricular ejection fraction. Assessment must be performed at least 12 weeks after major cardiac surgical intervention including coronary artery bypass graft (CABG), valvular repair/replacement, or cardiac resynchronization therapy (CRT) device implantation.

a. Left ventricular ejection fraction = 40% obtained during the screening visit OR either of the following i. Historical value of ejection fraction = 40% within 24 months of screening visit ii. Historical value of ejection fraction = 30% within 36 months of screening visit
5. Hemoglobin >9.0 g/dL and < 13.5 g/dL (females) or <15.0 g/dL (males) within 28 days of randomization.
6. Serum ferritin <100 ng/mL or 100 to 300 ng/mL with TSAT <20%.Patients with screening ferritin <15 ng/mL must have documentation of an appropriate evaluation, as determined by the Principle Investigator, within 3 months of screening and prior to randomization.
7. Either documented hospitalization for heart failure within 12 months of enrollment or elavated N-terminal-pro-brain natriuretic peptide (NT-proBNP) within 90 days of randomization. a. For patients in normal sinus rhythm: N-terminal-pro-brain natriuretic peptide (NT- proBNP) > 600 pg/mL (or BNP >200 pg/mL) . b . For patients in atrial fibrillation: NT-proBNP >1000 pg/mL (or BNP >400 pg/mL) .
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Known hypersensitivity reaction to any component of FCM.
2. History of acquired iron overload, or the recent receipt (within 3 months) of erythropoietin stimulating agent, IV iron therapy, or blood transfusion.
3. Acute myocardial infarction, acute coronary syndrome, transient ischemic attack, or stroke within 30 days of enrollment.
4. Uncorrected severe aortic stenosis, severe valvular regurgitation (except mitral regurgitation due to left ventricular dilatation without planned intervention), or left ventricular outflow obstruction requiring intervention.
5. Current atrial fibrillation or atrial flutter with a mean ventricular response rate >100 per minute (at rest).
6. Current or planned mechanical circulatory support or heart transplantation.
7. Hemodialysis or peritoneal dialysis (current or planned within the next 6 months).
8. Documented liver disease, or active hepatitis (i.e. alanine transaminase or aspartate transaminase >3 times the upper limit of normal range).
9. Current or recent (within 3 years) malignancy with exception of basal cell carcinoma or squamous cell carcinoma of the skin, or cervical intraepithelial neoplasia.
10. Active gastrointestinal bleeding.
11. Female participant of child-bearing potential who is pregnant, lactating, or not willing to use adequate contraceptive precautions during the study and for up to 5 days after the last scheduled dose of study medication.
12. Inability to return for follow up visits within the necessary windows
13. Concurrently in a study with investigational product.
14. No participants with Current Coronavirus Disease-19 (COVID-19) Infection into the study.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/03/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
2/02/2023
Sample size
Target
Accrual to date
Final
3065
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,SydneyTAS
Recruitment hospital [1] 0 0
SWSLHD-Liverpool Hospital - Liverpool
Recruitment hospital [2] 0 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [3] 0 0
Cairns Hospital - Cairns
Recruitment hospital [4] 0 0
The Prince Charles Hospital - Chermside
Recruitment hospital [5] 0 0
Core Research Group - Milton
Recruitment hospital [6] 0 0
Gold Coast University Hospital - Southport
Recruitment hospital [7] 0 0
The Queen Elizabeth Hospital - Adelaide
Recruitment hospital [8] 0 0
SA Heart - Ashford
Recruitment hospital [9] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [10] 0 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [11] 0 0
Heart Lung Clinic - Darlinghurst
Recruitment hospital [12] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [13] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [14] 0 0
Macquarie University - Clinical Trials Unit - Macquarie Park
Recruitment hospital [15] 0 0
John Hunter Hospital - New Lambton Heights
Recruitment hospital [16] 0 0
Epworth HealthCare Clinical Trials - Richmond
Recruitment postcode(s) [1] 0 0
1871 - Liverpool
Recruitment postcode(s) [2] 0 0
4575 - Birtinya
Recruitment postcode(s) [3] 0 0
4870 - Cairns
Recruitment postcode(s) [4] 0 0
4032 - Chermside
Recruitment postcode(s) [5] 0 0
4064 - Milton
Recruitment postcode(s) [6] 0 0
4215 - Southport
Recruitment postcode(s) [7] 0 0
5011 - Adelaide
Recruitment postcode(s) [8] 0 0
5035 - Ashford
Recruitment postcode(s) [9] 0 0
5042 - Bedford Park
Recruitment postcode(s) [10] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [11] 0 0
- Darlinghurst
Recruitment postcode(s) [12] 0 0
7000 - Hobart
Recruitment postcode(s) [13] 0 0
5000 - Adelaide
Recruitment postcode(s) [14] 0 0
2109 - Macquarie Park
Recruitment postcode(s) [15] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [16] 0 0
3121 - Richmond
Recruitment outside Australia
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United States of America
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Alabama
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Alaska
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Georgia
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Idaho
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Illinois
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Indiana
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Louisiana
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Maine
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Olawa
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Torun
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Warszawa
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Wolomin
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Wroclaw
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Lódz
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Russian Federation
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Chelyabinsk
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Kemerovo
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Russian Federation
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Moscow
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Pushkin
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Ryazan
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Saint Petersburg
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Russian Federation
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Saint-Petersburg
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Saratov
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Russian Federation
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St. Petersburg
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Ukraine
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Ivano-Frankivs'k
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Ukraine
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Kharkiv
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Ukraine
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Kryvyi Rih
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Ukraine
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Kyiv,
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Ukraine
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Kyiv
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Ukraine
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Lviv
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Ukraine
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Vinnytsia
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Ukraine
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Zaporizhzhia
Country [118] 0 0
Ukraine
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Zhytomyr

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
American Regent, Inc.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Duke Clinical Research Institute
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Adrian F Hernandez, MD
Address 0 0
Duke Clinical Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03037931