NL-OMON41512CompletedPhase 3
Multicentre, Prospective, Randomised, 2-arm Study to Assess the Impact of Ferric Carboxymaltose on Exercise Capacity in Chronic Heart Failure Patients with Iron Deficiency - FER-CARS-04 / EFFECT-HF (208/006)
Vifor Pharma - Vifor (International) Inc.0 sites27 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 27
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •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
- •6. At least 18 years of age.
- •7. Before any study-specific procedure, the appropriate written informed
- •consent must be obtained.
Exclusion Criteria
- •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)
- •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
- •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.
Investigators
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