Multicentre, prospective, randomised, 2-arm study to assess the impact of ferric carboxymaltose on exercise capacity in chronic heart failure patients with iron deficiency - EFFECT-HF
- Conditions
- MedDRA version: 14.1Level: PTClassification code 10022970Term: Iron deficiencySystem Organ Class: 10027433 - Metabolism and nutrition disordersMedDRA version: 14.1Level: LLTClassification code 10008908Term: Chronic heart failureSystem Organ Class: 10007541 - Cardiac disordersIron deficiency in patients with chronic heart failureTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2011-000603-40-IT
- Lead Sponsor
- VIFOR (INTERNATIONAL) INC.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 174
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 =45% (value within 3 months of planned date of randomisation). 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.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 64
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 96
1. Subject has known sensitivity to any of the products to be administered during dosing. 1. History of acquired iron overload. 2. History of erythropoietin stimulating agent, IV iron therapy, and/or blood transfusion in previous 6 weeks prior to randomisation. 3. Exercise training program(s) in the 3 months prior to screening or planned in the next 6 months. 4. Subject at an immediate need of transfusion or haemoglobin (Hb) >15 g/dL. 5. Known active bacterial infection. 6. Chronic liver disease and/or screening alanine transaminase or aspartate transaminase above 3 times the upper limit of the normal range. 7. Vitamin B12 and/or serum folate deficiency. If deficiency corrected subject may be rescreened for inclusion. 8. Known human immunodeficiency virus/acquired immunodeficiency syndrome or active hepatitis B or C. 9. Clinical evidence of current malignancy with exception of basal cell or squamous cell carcinoma of the skin, and cervical intraepithelial neoplasia. 10. Currently receiving systemic chemotherapy and/or radiotherapy. 11. Renal dialysis (previous, current or planned within the next 6 months). 12. 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. 13. Acute myocardial infarction or acute coronary syndrome, transient ischaemic attack or stroke within the last 3 months prior to randomisation. 14. 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. 15. 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). 16. Subject of child-bearing potential who is pregnant (e.g., positive human chorionic gonadotropin test) or is breast feeding. 17. Subject is not using adequate contraceptive precautions during the study and for up to 5 days after the last dose of the study medication. 18. 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. 19. Subject will not be available for all protocol specified assessments. 20. 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of intravenous (IV) FCM compared to usual care on exercise capacity.;Secondary Objective: • To evaluate the efficacy of IV FCM compared to usual care on biomarkers for iron deficiency (ID), cardiac biomarkers, New York Heart Association (NYHA) functional class, patient global assessment (PGA), quality of life (QoL), renal function, cardiac function as assessed by echocardiography (ECHO) and iron requirements in iron-deficient CHF subjects. • To evaluate the safety of IV FCM over the treatment period.;Primary end point(s): • Change in peak VO2 (mL/kg/min) from baseline to Week 24;Timepoint(s) of evaluation of this end point: Week 24
- Secondary Outcome Measures
Name Time Method