Treatment With IV Iron in Hospitalized Patients With Severe Heart Failure But Without Iron Deficiency
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Quality of life improvement
研究概览
简要总结
Patients with congestive heart failure, grade 3-4, in addition to the standard care, will be randomized 1:1. The study group will receive 2 doses of IV iron (Iron carboxymaltose). The control group will receive standard of care alone. The study will test for the effects of the additional IV iron on the symptoms, clinical picture and quality of life of the treated patients.
详细描述
Patients with congestive heart failure, grade 3-4, in addition to the standard care, will be randomized 1:1. The study group will receive 2 doses of IV iron (Iron carboxymaltose). The control group will receive standard of care alone. The study will test for the effects of the additional IV iron on the symptoms, clinical picture and quality of life of the treated patients. The parameters that will be measured will include clinical, lab, echo, and quality of life questionnaires.
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
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Heart failure grade 3-4
- •Heart echo EF< 40% (ejection fraction)
- •Hb > 10 mg/dL
- •Iron> 50 mic/dL
- •Iron/ transferrin rate > 20%
排除标准
- •Infection
- •Acute ischemia
- •Patients that didn't receive the standard of care during 3 days before investigational product administration
- •Hemochromatosis
- •Known allergy to one of the products of the investigational product.
- •Macrocytic anemia
- •Iron excess
- •Pregnant women
- •Mentally disabled patients which can't give their concent properly.
研究组 & 干预措施
Iron Carboxymaltose
standard of care + double dose of IV iron ferinject
the medicine will be given twice within one week.
干预措施: Standard of care (Other)
Iron Carboxymaltose
standard of care + double dose of IV iron ferinject
the medicine will be given twice within one week.
干预措施: Iron Carboxymaltose (Drug)
control
standard of care
干预措施: Standard of care (Other)
结局指标
主要结局
Quality of life improvement
时间窗: 1 month after second administration
KCCQ (The Kansas City Cardiomyopathy Questionnaire)
Functioning improvement
时间窗: 1 month after second administration
NYHA assesment (New York Heart Association (NYHA) Functional Classification)
次要结局
未报告次要终点