NCT03380520已完成4 期
Effect of Intravenous FerRic carbOxymaltose oN Reverse Remodeling Following Cardiac Resynchronization Therapy
Hasselt University1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2017年10月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Change in left ventricular ejection fraction from baseline
研究概览
简要总结
To assess impact on left ventricular reverse remodeling defined as a change in left ventricular ejection fraction in heart failure patients with reduced ejection fraction (and previous implantation of cardiac resynchronization therapy) undergoing treatment with ferric carboxymaltose vs. placebo
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic heart failure and implantation of cardiac resynchronization therapy more than 6 months ago and presence of iron deficiency (ferritin < 100 μg/l, irrespective of TSAT or ferritine between 100 - 300 μg/l with TSAT < 20%) and presence of incomplete reverse remodeling (LVEF < 40%).
- •Age ≥18 years
- •Obtained informed consent
- •Stable pharmacological therapy of heart failure during the last 4 weeks (with the exception of diuretics)
排除标准
- •Hemochromatosis, iron overload, defined as TSAT > 45%
- •Hemoglobin > 15 g/dl at inclusion
- •Known hypersensitivity to injectafer®.
- •Known active infection, CRP>20 mg/L, clinically significant bleeding, active malignancy.
- •Chronic liver disease and/or screening alanine transaminase (ALT) or aspartate transaminase (AST) above three times the upper limit of the normal range.
- •Immunosuppressive therapy or renal dialysis (current or planned within the next 6 months).
- •History of erythropoietin, i. v. or oral iron therapy, and blood transfusion in previous 12 weeks and/or such therapy planned within the next 6 months.
- •Unstable angina pectoris as judged by the investigator, clinically significant uncorrected valvular disease or left ventricular outflow obstruction, obstructive cardiomyopathy, poorly controlled fast atrial fibrillation or flutter, poorly controlled symptomatic brady- or tachyarrhythmias.
- •Acute myocardial infarction or acute coronary syndrome, transient ischemic attack or stroke within the last 3 months.
- •Coronary-artery bypass graft, percutaneous intervention (e.g. cardiac, cerebrovascular, aortic; diagnostic catheters are allowed) or major surgery, including thoracic and cardiac surgery, within the last 3 months.
- •Inability to fully comprehend and/or perform study procedures in the investigator's opinion.
- •Vitamin B12 and/or serum folate deficiency according to the laboratory (re-screening is possible after substitution therapy).
- •Pregnancy or lactation.
- •Participation in another clinical trial within previous 30 days and/or anticipated participation in another trial during this study.
- •Planned cardiac hospitalization during study follow-up
研究组 & 干预措施
Ferric carboxymaltose
Experimental
Ferric carboxymaltose according to SmPC
干预措施: Ferric Carboxymaltose (Drug)
Placebo
Placebo Comparator
Normal saline (0.9%)
干预措施: Placebo (Drug)
结局指标
主要结局
Change in left ventricular ejection fraction from baseline
时间窗: 3 months
delta_LVEF measured by 3D-echocardiography
次要结局
- Change in left ventricular end diastolic volume from baseline(3 months)
- Force frequency relationship(3 months)
- Change in left ventricular end systolic volume from baseline(3 months)
- Heart failure hospitalization and all-cause mortality(Up to six months)
- Incidence of Treatment-associated Serious and non-serious adverse events.(During intravenous study drug administration and 1-hour in hospital follow-up)
研究者
Wilfried Mullens, MD PhD
Md PhD
Hasselt University
研究点 (1)
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