Multicentre, Prospective, Randomised, 2-arm Study to Assess the Impact of Ferric Carboxymaltose on Exercise Capacity in Chronic Heart Failure Patients with Iron Deficiency
- Conditions
- Hart failure with Iron deficiency1002295810019280
- Registration Number
- NL-OMON41512
- Lead Sponsor
- Vifor Pharma - Vifor (International) Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 27
1. Subjects with stable CHF (NYHA II-III functional class) on optimal
background therapy (as determined by the Investigator) for at least 4 weeks
with no dose changes of heart failure drugs during the last 2 weeks (with
the exception of diuretics). In general, optimal pharmacological treatment
should include a diuretic, a beta-blocker, and/or an angiotensin converting
enzyme inhibitor or angiotensin II receptor blocker unless contraindicated
or not tolerated.
2. Left ventricular ejection fraction (LVEF) <=45% (historical value can be used if performed within 3 months of screening start).
3. Exercise limitation as evidenced by reproducible peak VO2
10-18 mL/kg/min during screening. This will be estimated by 2 tests
(completed within 4 weeks of each other and at least 3 days between each
other) with at least 1 test completed within 4 weeks before baseline visit.
Historical peak VO2 test can be used as Test 1 if performed within 4 weeks
before screening. The 2 tests must have less than 10% difference in values.
If more than 10%, a third test may be performed within 4 weeks and at
least 3 days after Test 2. For the baseline test, the respiratory exchange
ratio (RER) >=1.0.
4. Brain natriuretic peptide (BNP) >100 pg/mL and/or N-terminal-pro-BNP
(NT-proBNP) >400 pg/mL.
5. Screening ferritin <100 ng/mL OR ferritin 100-300 ng/mL with TSAT
<20%.
6. At least 18 years of age.
7. Before any study-specific procedure, the appropriate written informed
consent must be obtained.
1. Subject has known sensitivity to any of the products to be administered
during dosing.
2. History of acquired iron overload.
3. History of erythropoietin stimulating agent, IV iron therapy, and/or blood
transfusion in previous 6 weeks prior to randomisation.
4. Exercise training program(s) in the 3 months prior to screening or planned
in the next 6 months.
5. Subject at an immediate need of transfusion or haemoglobin (Hb)
>15 g/dL.
6. Known active bacterial infection.
7. Chronic liver disease and/or screening alanine transaminase or aspartate
transaminase above 3 times the upper limit of the normal range.
8. Vitamin B12 and/or serum folate deficiency that requires treatment. Once deficiency corrected subject may be rescreened for inclusion.
may be rescreened for inclusion.
9. Known human immunodeficiency virus/acquired immunodeficiency
syndrome or active hepatitis B or C.
10. Clinical evidence of current malignancy with exception of basal cell or
squamous cell carcinoma of the skin, and cervical intraepithelial neoplasia.
11. Currently receiving systemic chemotherapy and/or radiotherapy.
12. Renal dialysis (previous, current or planned within the next 6 months).
13. Unstable angina pectoris as judged by the Investigator; severe valvular or
left ventricular outflow obstruction disease needing intervention; atrial
fibrillation/flutter with a mean ventricular response rate at rest >100 beats
per minute.
14. Acute myocardial infarction or acute coronary syndrome, transient
ischaemic attack or stroke within the last 3 months prior to randomisation.
15. Coronary-artery bypass graft, percutaneous intervention (e.g., cardiac,
cerebrovascular, aortic; diagnostic catheters are allowed) or major surgery,
including thoracic and cardiac surgery, within the last 3 months prior to
randomisation.
16. Subject currently is enrolled in or has not yet completed at least 30 days
since ending other investigational device or drug study (ies), or subject is
receiving other investigational agent(s).
17. Subject of child-bearing potential who is pregnant (e.g., positive human
chorionic gonadotropin test) or is breast feeding.
18. Subject is not using adequate contraceptive precautions during the study
and for up to 5 days after the last dose of the study medication.
19. Subject previously randomised to this study. Note: Subjects may be
rescreened if they fail any of the screening procedures. If rescreened, all
tests must fall inside the maximum specified screening windows for each
criterion.
20. Subject will not be available for all protocol specified assessments.
21. Subject has any kind of disorder that compromises the ability of the subject
to give written informed consent and/or to comply with study procedures.
22. Subject with body weight <35 kg.
23. Subject has previously been randomized in FER-CARS-05.
24. Cardio resynchronization therapy device implantation within 6 months prior to screening.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary Endpoint:<br /><br>• Change in peak VO2 (mL/kg/min) from baseline to Week 24</p><br>
- Secondary Outcome Measures
Name Time Method