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临床试验/EUCTR2016-003604-31-ES
EUCTR2016-003604-31-ES进行中（未招募）1 期

Effects of intravenous iron therapy with ferric carboxymaltose compared with oral irontherapy in heart failure with preserved ejection fraction and iron deficiency. ( PREFER-HF) - PREFER-HF

José Luis Morales Rull, Institut de Recerca Biomédica Lleida IRB Hospital Arnau de Vilanova Servicio de Medicina Interna0 个研究点开始时间: 2016年11月17日最近更新:
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适应症
相关药物

试验速览

阶段
1 期
状态
进行中（未招募）
发起方
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • •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 <100 ng/mL or 100–300 ng/mL with transferrin saturation <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:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 12
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 60
  • •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 <100 ng/mL or 100–300 ng/mL with transferrin saturation <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:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 12
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 60
  • •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 <100 ng/mL or 100–300 ng/mL with transferrin saturation <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:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 12
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 60

排除标准

  • •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 <75 mg/day is permitted.
  • •5. Body weight =/<35 kg.
  • •6. Exercise training programme(s) in the 3 months prior to screening or planned in the next 6 months.
  • •7. Subject at an immediate need of transfusion or haemoglobin >/= 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.
  • •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 <75 mg/day is permitted.
  • •5. Body weight =/<35 kg.
  • •6. Exercise training programme(s) in the 3 months prior to screening or planned in the next 6 months.
  • •7. Subject at an immediate need of transfusion or haemoglobin >/= 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.
  • 另有 31 项未显示

研究者

发起方
José Luis Morales Rull, Institut de Recerca Biomédica Lleida IRB Hospital Arnau de Vilanova Servicio de Medicina Interna

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