NCT06929806招募中3 期
A Phase III, Randomized, Open-label, Blinded Endpoint, Comparative Trial of Ferric Derisomaltose Versus no Intravenous Iron in Iron-deficient Subjects With Symptomatic Chronic Heart Failure
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,900
- 试验地点
- 1
- 主要终点
- Number of cardiovascular deaths and hospitalizations for worsening heart failure
研究概览
简要总结
The goal of this clinical trial is to learn if the IV Iron treatment ferric derisomaltose helps in the treatment of chronic heart failure in people with iron deficiency. The main question it aims to answer is:
• How many participants are admitted to the hospital or die from a disease in the heart or blood vessels
Researchers will compare treatment with ferric derisomaltose to no treatment with ferric derisomaltose. This will be done to see how well ferric derisomaltose works.
Participants will:
- Be randomized 50/50 to either treatment with Ferric derisomaltose or to no treatment with ferric derisomaltose
- All participants receives standard of care
- Visit site 4-5 times and have 7 video/phone-calls
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •Both women and men can join
- •Heart failure that causes fatigue, shortness of breath, or other symptoms during physical activity
- •Have left ventricle (chamber) ejection fraction (pumping ability) that is 45% or less
- •Have low iron levels in the blood
- •New York Heart Association (NYHA) Heart Failure Classification II, III or IV
排除标准
- •Planned cardiac surgery or revascularization or cardiac device implantation
- •Pregnant or nursing women
- •Treatment with iron Intravenous (through the vein) or intramuscular (injection in the muscle) within the past 6 months
- •Treatment with radiotherapy or chemotherapy
研究组 & 干预措施
Ferric Derisomaltose
Experimental
50 % of the subjects will be treated with Ferric Derisomaltose 100 mg/mL The ferric derisomaltose dose administered is dependent on the subject's weight and hemoglobin (Hb) level. Subjects treated with ferric derisomaltose will be eligible for re-dosing if transferrin saturation (TSAT) remains below <25 %
干预措施: Ferric Derisomaltose (Drug)
结局指标
主要结局
Number of cardiovascular deaths and hospitalizations for worsening heart failure
时间窗: From enrollment to the end of follow-up at 52 weeks
次要结局
- Number of hospitalizations for worsening heart failure(From enrollment and no longer than end of follow-up at 52 weeks)
- Time to cardiovascular death(From enrollment to the end of follow-up at 52 weeks)
- Number of all-cause hospitalizations(From enrollment to the end of follow-up at 52 weeks)
- Time to all-cause death(From enrollment to the end of follow-up at 52 weeks)
- Time to first hospitalization for worsening heart failure or cardiovascular death(From enrollment to the end of follow-up at 52 weeks)
- Number of hospitalizations for cardiovascular, respiratory, or renal disease(From enrollment to the end of follow-up at 52 weeks)
- Time to cardiovascular, respiratory, or renal death(From enrollment to the end of follow-up at 52 weeks)
- Number of hospitalizations for cardiovascular events: stroke, AMI and heart failure(From enrollment to the end of follow-up at 52 weeks)
- Time to cardiovascular death or first hospitalization for cardiovascular event: stroke, AMI and heart failure(From enrollment to the end of follow-up at 52 weeks)
- Time to all-cause death or first hospitalization(From enrollment to the end of follow-up at 52 weeks)
- Days hospitalized or dead for cardiovascular reasons at week 52(From enrollment to the end of follow-up at 52 weeks)
- Days hospitalized or dead for any reason at week 52(From enrollment to the end of follow-up at 52 weeks)
- Change in NYHA from baseline to weeks 12, 26 and 52(From enrollment to weeks 12, 26 and 52)
- All-cause rehospitalizations at 30 and 60 days(From enrollment to 30 and 60 days)
- Rehospitalizations for worsening heart failure at 30 and 60 days(From enrollment to 30 and 60 days)
- Number of cardiovascular deaths and hospitalizations for worsening heart failure including urgent and unscheduled outpatient IV diuretic treatment(From enrollment to the end of follow-up at 52 weeks)
- Number of urgent and unscheduled outpatient IV diuretic treatment(From enrollment to the end of follow-up at 52 weeks)
研究者
研究点 (1)
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