Pilot Study to Assess the Effect of Low Dose Epoetin Beta Administered for Six Month in Patients With Ischemic Heart Failure Subjected to Percutaneous Coronary Intervention (PCI)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Change in global left ventricular ejection fraction between initial examination at study entry and the 6 months follow up examination employing cardiac MRI
研究概览
简要总结
The study is testing the hypothesis, that the application of low dose erythropoetin beta (35 I.E./kg BW/week) for 6 months following successful coronary revascularization by PCI improves left ventricular remodeling as assessed by cardiac MRI.
详细描述
Several effects known to be exerted by erythropoetin (EPO) directly in the heart independent of hemoglobin levels could be of value immediately after revascularization procedures in ischemic cardiac remodeling: the generation of new capillaries is enhanced by the mobilization of endothelial progenitor cells from the bone marrow. EPO is neuron- and cardio-protective after ischemia/reperfusion. Administration of EPO enhances neuronal progenitors to differentiate into functional neurons; this observation may also be valid for the cardiac compartment. The concept of organ-specific effects of EPO independent of hemoglobin levels is supported by the analysis of EPO analogues lacking hematopoietic activity. In humans, currently this concept can only be tested by the use of EPO-doses that do not affect hemoglobin levels. The concept is valid as clinical trials have been performed showing that doses as low as 5000 I.U. EPO once weekly increase the levels of endothelial progenitor cells in blood. On the other hand, recent clinical trials have also shown neutral or even deleterious effects of high dose EPO treatment raising hemoglobin levels to above 12mg/dl in pre-dialysis patients concerning cardiovascular endpoints. Therefore, the chronic, hemoglobin-neutral administration of low doses of EPO might be a successful approach concerning ischemic cardiomyopathy.
Study outline:
This investigator initiated, double-blind, placebo-controlled study is testing the hypothesis, that low doses of erythropoietin beta (35 I.U./kg body weight) started within 14 days after a successful percutaneous coronary intervention enhance left ventricular remodeling as determined by comparison of two cardiac MRI´s over a course of 6 months. Secondary endpoints include changes in diastolic dysfunction as measured by echocardiography, VO2 measured by spiroergometry and serum brain natriuretic peptide levels.
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
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •successful coronary intervention < 14 days
- •regional contraction deficit of the left ventricle as detected either by echocardiography or cardiacMRI
- •globally reduced ejection fraction (cardiac MRI or echocardiography: < 60%)
- •willing and able to cooperate
- •voluntary participation
排除标准
- •contraindication for cardiac MRI (i.e. pacemaker, ICD current or within the next 6 months, other metal implants)
- •cardiogenic shock at time of inclusion
- •uncontrolled hypertension (systolic blood pressure > 180mmHg)
- •hemoglobin > 16mg/dl
- •thrombocytosis
- •malignant tumor
- •missing informed consent
- •renal failure (creatinine > 300 mg/dl)
- •liver failure
- •other prognosis limiting, severe diseases (i.e. dementia)
- •indication for open label erythropoietin treatment
- •allergy towards solvents of the EPO preparation
- •woman of childbearing potential
- •other clinical study within the preceding 30days
- •known alcohol or drug abuse
- •neurologic or psychiatry disorders
- •previous organ transplantation
研究组 & 干预措施
1
35 I.E. erythropoetin beta given by subcutaneous injection once per week for 6 months. The drug is self-administered.
干预措施: erythropoetin beta (Drug)
2
Placebo to erythropoetin beta.
干预措施: placebo (Drug)
结局指标
主要结局
Change in global left ventricular ejection fraction between initial examination at study entry and the 6 months follow up examination employing cardiac MRI
时间窗: 6 months
次要结局
- The application of 35 I.E./kg body weight erythropoetin beta s.c. once per week for 6 months is well tolerated and safe in patients after PCI.(6 months)
- 35 I.E. kg/KG erythropoetin beta s.c. once per week for 6 months improves left ventricular regional wall motion as assessed by cardiac MRI.(6 months)
- 35 I.E. kg/KG erythropoetin beta s.c. once per week for 6 months reduces serum levels of brain natriuretic peptide as a measure of heart failure.(6 months)
- 35 I.E. kg/KG erythropoetin beta s.c. once per week for 6 months improves peak VO2 as measured by spiroergometry(6 months)
- 35 I.E. kg/KG erythropoetin beta s.c. once per week for 6 months improves measures or cardiac diastolic dysfunction as assessed by echocardiography(6 months)
- 35 I.E. kg/KG erythropoetin beta s.c. once per week for 6 months improves cardiac tissue texture aqs assessed by contrast-enhanced cardiac MRI(6 months)