Patients with heart failure with preserved ejection fraction ( HFpEF) and iron deficency anemia.
Conditions
Interventions
Trade Name: Ferinject 50 mg/ml
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: FERRIC CARBOXYMALTOSE
CAS Number: 9007-72-1
Concentration unit: mg/ml milligram(s)/millilitre
C
Sponsors
José Luis Morales Rull, Institut de Recerca Biomédica Lleida IRB Hospital Arnau de Vilanova Servicio de Medicina Interna
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects with stable chronic HF (NYHA II/IV 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 an angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker and a beta blocker unless contraindicated or not tolerated and diuretic if indicated. 2. Left ventricular ejection fraction >45% (value within 3 months of planned date of randomization). 3. BNP >100 pg/mL and/or N-terminal-pro-BNP >400 pg/mL at the screening visit. 4. Subject must be capable of completing the 6MWT. 5. Screening serum ferritin =65 years) yes F.1.3.1 Number of subjects for this age range 60 ;Inclusion criteria: 1. Subjects with stable chronic HF (NYHA II/IV 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 an angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker and a beta blocker unless contraindicated or not tolerated and diuretic if indicated. 2. Left ventricular ejection fraction >45% (value within 3 months of planned date of randomization). 3. BNP >100 pg/mL and/or N-terminal-pro-BNP >400 pg/mL at the screening visit. 4. Subject must be capable of completing the 6MWT. 5. Screening serum ferritin =65 years) yes F.1.3.1 Number of subjects for this age range 60 ;Inclusion criteria: 1. Subjects with stable chronic HF (NYHA II/IV 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 an angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker and a beta blocker unless contraindicated or not tolerated and diuretic if indicated. 2. Left ventricular ejection fraction >45% (value within 3 months of planned date of randomization). 3. BNP >100 pg/mL and/or N-terminal-pro-BNP >400 pg/mL at the screening visit. 4. Subject must be capable of completing the 6MWT. 5. Screening serum ferritin =65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
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, i.v. iron therapy, and/or blood transfusion in previous 6 weeks prior to randomization. 4. Oral iron therapy at doses >100 mg/day in previous 1 week prior to randomization. Note: ongoing use of multivitamins containing iron /= 15 g/dL. 8. Known active bacterial infection. 9. Chronic liver disease (including active hepatitis) and/or screening alanine transaminase or aspartate transaminase above three times the upper limit of the normal range. 10. Subjects with known hepatitis B surface antigen positivity and/or hepatitis C virus ribonucleic acid positivity. 11. Vitamin B12 and/or serum folate deficiency. If deficiency-corrected subject may be rescreened for inclusion. 12. Subjects with known seropositivity to human immunodeficiency virus. 13. Clinical evidence of current malignancy with exception of basal cell or squamous cell carcinoma of the skin, and cervical intraepithelial neoplasia. 14. Currently receiving systemic chemotherapy and/or radiotherapy. 15. Renal dialysis (previous, current, or planned within the next 6 months). 16. 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. 17. Acute myocardial infarction or acute coronary syndrome, transient ischaemic attack, or stroke within the last 3 months prior to randomization. 18. Coronary artery bypass graft, percutaneous intervention (e.g. cardiac, cerebrovascular, and aortic; diagnostic catheters are allowed), or major surgery, including thoracic and cardiac surgery, within the last 3 months prior to randomization. 19. 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). 20. Subject of childbearing potential who is pregnant (e.g. positive human chorionic gonadotropin test) or is breastfeeding. 21. Subject is not willing to use adequate contraceptive precautions during the study and for up to 5 days after the last scheduled dose of study medication. 22. Subject previously randomized 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. 23. Subject will not be available for all protocol-specified assessments. 24. 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. 25. Lactose intolerance. 26. Pregnant woman. ;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, i.v. iron therapy, and/or blood transfusion in previous 6 weeks prior to randomization. 4. Oral iron therapy at doses >100 mg/day in previous 1 week prior to randomization. Note: ongoing use of multivitamins containing iron /= 15 g/dL. 8. Known active bacterial infection. 9. Chronic liver disease (including active hepatitis) and/or screening alanine transaminase or aspartate transaminase above three times the upper limit of the normal range. 10. Subjects with known hepatitis B surface antigen positivity and/or hepatitis C virus ribonucleic acid positivity. 11. Vitamin B12 and/or serum folate deficiency. If deficiency-corrected subject may be rescreened for inclusion. 12. Subjects with known seropositivity to human immunodeficiency virus. 13. Clinical evidence of current malignancy with exception of basal cell or squamous cell carcinoma of the skin, and cervical intraepithelial neoplasia. 14. Currently receiving systemic chemotherapy and/or radiotherapy. 15. Renal dialysis (previous, current, or planned within the next 6 months). 16. 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. 17. Acute myocardial infarction or acute coronary syndrome, transient ischaemic attack, or stroke within the last 3 months prior to randomization. 18. Coronary artery bypass graft, percutaneous intervention (e.g. cardiac, cerebrovascular, and aortic; diagnostic catheters are allowed), or major surgery, including thoracic and cardiac surgery, within the last 3 months prior to randomization. 19. 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). 20. Subject of childbearing potential who is pregnant (e.g. positive human chorionic gonadotropin test) or is breastfeeding. 21. Subject is not willing to use adequate contraceptive precautions during the study and for up to 5 days after the last scheduled dose of study medication. 22. Subject previously randomized 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. 23. Subject will not be available for all protocol-specified assessments. 24. 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. 25. Lactose intolerance. 26. Pregnant woman. ;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, i.v. iron therapy, and/or blood transfusion in previous 6 weeks prior to randomization. 4. Oral iron therapy at doses >100 mg/day in previous 1 week prior to randomization. Note: ongoing use of multivitamins containing iron /= 15 g/dL. 8. Known active bacterial infection. 9. Chronic liver disease (including active hepatitis) and/or screening alanine transaminase or aspartate transaminase above three times the upper limit of the normal range. 10. Subjects with known hepatitis B surface antigen positivity and/or hepatitis C virus ribonucleic acid positivity. 11. Vitamin B12 and/or serum folate deficiency. If deficiency-corrected subject may be rescreened for inclusion. 12. Subjects with known seropositivity to human immunodeficiency virus. 13. Clinical evidence of current malignancy with exception of basal cell or squamous cell carcinoma of the skin, and cervical intraepithelial neoplasia. 14. Currently receiving systemic chemotherapy and/or radiotherapy. 15. Renal dialysis (previous, current, or planned within the next 6 months). 16. 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. 17. Acute myocardial infarction or acute coronary syndrome, transient ischaemic attack, or stroke within the last 3 months prior to randomization. 18. Coronary artery bypass graft, percutaneous intervention (e.g. cardiac, cerebrovascular, and aortic; diagnostic catheters are allowed), or major surgery, including thoracic and cardiac surgery, within the last 3 months prior to randomization. 19. 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). 20. Subject of childbearing potential who is pregnant (e.g. positive human chorionic gonadotropin test) or is breastfeeding. 21. Subject is not willing to use adequate contraceptive precautions during the study and for up to 5 days after the last scheduled dose of study medication. 22. Subject previously randomized 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. 23. Subject will not be available for all protocol-specified assessments. 24. 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. 25. Lactose intolerance. 26. Pregnant woman.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assess whether intravenous treatment with iron carboxymaltose or oral treatment (ferroglicina iron sulfate or liposome) in patients with HF Preserved LVEF and iron deficiency anemia, can improve functional capacity measured by the 6-minute walk (6MWT) test compared to placebo at 30 weeks after the start of treatment.;Secondary Objective: To determine whether IV ferric carboxymaltose improve NYHA class and quality of life (Living with Heart Failure Minessota questionnaire), and reduce mortality and hospitalizations, in patients with HFpEF in comparison with oral iron.;Primary end point(s): Change in 6MWT distance from baseline to Week 24 visit after the start of investigational drug.;Timepoint(s) of evaluation of this end point: 24 weeks;Main Objective: Assess whether intravenous treatment with iron carboxymaltose or oral treatment (ferroglicina iron sulfate or liposome) in patients with HF Preserved LVEF and iron deficiency anemia, can improve functional capacity measured by the 6-minute walk (6MWT) test compared to placebo at 30 weeks after the start of treatment.;Secondary Objective: To determine whether IV ferric carboxymaltose improve NYHA class and quality of life (Living with Heart Failure Minessota questionnaire), and reduce mortality and hospitalizations, in patients with HFpEF in comparison with oral iron.;Primary end point(s): Change in 6MWT distance from baseline to Week 24 visit after the start of investigational drug.;Timepoint(s) of evaluation of this end point: 24 weeks;Main Objective: Assess whether intravenous treatment with iron carboxymaltose or oral treatment (ferroglicina iron sulfate or liposome) in patients with HF Preserved LVEF and iron deficiency anemia, can improve functional capacity measured by the 6-minute walk (6MWT) test compared to placebo at 30 weeks after the start of treatment.;Secondary Objective: To determine whether IV ferric carboxymaltose improve NYHA class and quality of life (Living with Heart Failure Miness | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Change in NYHA class at Weeks 6, 12, 24 and 30 - Change Kansas City Cardiomyopathy questionnaire (KCCQ to to Weeks 6, 12, 24 and 30 - Rate of any, HF-related or other cardiovascular hospitalizations. - Time to the first hospitalization for any reason, for worsening of CHF, other cardiovascular-related events, or for any cardiovascular reason.;Timepoint(s) of evaluation of this end point: Weeks 6, 12, 24 and 30;Secondary end point(s): - Change in NYHA class at Weeks 6, 12, 24 and 30 - Change Kansas City Cardiomyopathy questionnaire (KCCQ to to Weeks 6, 12, 24 and 30 - Rate of any, HF-related or other cardiovascular hospitalizations. - Time to the first hospitalization for any reason, for worsening of CHF, other cardiovascular-related events, or for any cardiovascular reason.;Timepoint(s) of evaluation of this end point: Weeks 6, 12, 24 and 30;Secondary end point(s): - Change in NYHA class at Weeks 6, 12, 24 and 30 - Change Kansas City Cardiomyopathy questionnaire (KCCQ to to Weeks 6, 12, 24 and 30 - Rate of any, HF-related or other cardiovascular hospitalizations. - Time to the first hospitalization for any reason, for worsening of CHF, other cardiovascular-related events, or for any cardiovascular reason.;Timepoint(s) of evaluation of this end point: Weeks 6, 12, 24 and 30 | — |
Countries
Spain
Contacts
Public ContactServicio Científico Técnico Farma;Servicio Científico Técnico Farma;Servicio Científico Técnico Farma ;;
Institut de Recerca Biomèdica de Lleida (IRB);Institut de Recerca Biomèdica de Lleida (IRB);Institut de Recerca Biomèdica de Lleida (IRB)
Outcome results
None listed