EUCTR2016-004194-40-ES进行中（未招募）1 期
Changes in Myocardial Iron Content Following Administration of Intravenous Iron
Instituto de Investigación Sanitaria INCLIVA0 个研究点目标入组 50 人开始时间: 2016年12月12日最近更新:
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
- 入组人数
- 50
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. Patients with ambulatory chronic HF
- •2. Older than 18 years.
- •3. Patients in NYHA class II-III on optimal background therapy (as determined by the investigator) for at least 4 weeks with no dose changes of HF drugs during the last 2 weeks (with the exception of diuretics).
- •4. Elevated natriuretic peptides levels (NT-proBNP >400 pg/ml) at the screening visit
- •5. LVEF <50% documented in the last 12 months.
- •6. Iron deficiency defined as: serum ferritin level <100 µg/L or ferritin level 100-299 µg/L when TSAT is less than 20%, and hemoglobin <15 g/dL (all at screening).
- •7. Participant is willing and able to give informed consent for participation in the study.
- •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 5
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 45
排除标准
- •The participant may not enter the study if ANY of the following conditions is present:
- •1. Known sensitivity to any of the products to be administered per protocol.
- •2. History of acquired iron overload.
- •3 Severe valve disease, or being scheduled for cardiac surgery within the next 30 days
- •4 Acute myocardial infarction or acute coronary syndrome, transient ischemic attack, or stroke within the last 3 months prior to randomization.
- •5. Coronary artery bypass graft, percutaneous intervention (e.g. cardiac, cerebrovascular, and aortic; diagnostic catheters are llowed), or major surgery, including thoracic and cardiac surgery, within the last 3 months prior to randomization.
- •6. Ischemic heart disease scheduled for revascularization procedures within the next 30 days.
- •7. HF scheduled for cardiac resynchronization therapy within the next 30 days.
- •8. Patients with active bleeding in the last 30 days.
- •9. Known active infection or active malignancy.
- •10. Subject at an immediate need of transfusion or hemoglobin =15 g/dL.
- •11. Anemia due to reasons other than iron deficiency
- •12. Immunosuppressive therapy or renal dialysis
- •13. History of erythropoietin, intravenous iron therapy, and blood transfusion in the previous 12 weeks.
- •14. Oral iron therapy at doses >100 mg/day in previous 1 week prior to randomization.
- •15. Subjects with an immediate need for transfusion.
- •16. Pregnant or breastfeeding women.
- •17. Subject of childbearing potential who 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.
- •18. Subject currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study, or subject is receiving other investigational agent(s).
- •19. Any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures.
研究者
相似试验
尚未招募
不适用
Identify blood iron level and its any association with heart problemCTRI/2021/09/036725Dr varsha yadav
已完成
不适用
Iron Status In Decompensated Heart Failure (IRON STATS-DHF)Heart failureISRCTN80063369Portsmouth Hospitals NHS Trust (UK)150
尚未招募
不适用
Iron status and outcome in cardiac surgeryabnormal iron status, cardiac surgeryNL-OMON27402Amphia Hospital400
已完成
3 期
The Effect of Iron Supplementation on the Factors Affecting the Aerobic Capacity of Women AthletesThe Effect of Iron Supplementation on the Factors Affecting the Aerobic Capacity of Women Athletes.IRCT20230816059165N1The University of Shiraz20
已完成
4 期
Changes in Myocardial Iron After Iron AdministrationIron-deficiencyHeart FailureNCT03398681Fundación para la Investigación del Hospital Clínico de Valencia53