Retrograde Application of Bone Marrow Aspirate Concentrate (BMAC) Through Coronary Sinus in Patients With Congestive Heart Failure of Ischemic Etiology
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Left ventricular end-systolic volume (LVESV)
研究概览
简要总结
The aim of our prospective randomised study is to assess the efficacy of the retrograde application of non-selected bone marrow autologous cells concentrate (BMAC) in patients with heart failure with reduced ejection fraction of left ventricle (HFREF) of ischemic aetiology. The evaluated preparation is concentrated BMAC, obtained using Harvest SmartPReP2 technology.
详细描述
Our assumption is that non-selected BMAC administrations will lead to improvements in the left ventricular ejection fraction (LV EF), the left ventricular end-systolic and end-diastolic diameters and volumes (measured with magnetic resonance imaging) compared to standard heart failure therapy.
Furthermore, it will be associated with improved exercise tolerance in the six-minute corridor walk test and an improvement in the life quality of patients without increasing the incidence of severe ventricular arrythmias.
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
- Double (Participant, 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
- •Patients with chronic heart failure and left ventricular ejection fraction ≤ 40% with coronary artery disease and with symptoms of heart failure in the NYHA class ≥ 3 on standard heart failure therapy for 3 months and in a stabilised state for at least 1 month
- •Age ≥18 years
- •Informed, written consent by the patient
- •Ability to comply fully with the study protocol
- •Negative pregnancy test (and effective contraception) in women with childbearing potential
排除标准
- •Previous bone marrow disease (especially myelodysplastic syndrome or non-Hodgkin's lymphoma)
- •Acute myocardial infarction ˂ 1 week
- •Active infection or antibiotics treatment ˂ 1 week
- •Previous malingant ventricular arrhythmias without cardioverter-defibrilator (ICD) implantation
- •Anemia (HTC≤28%), leukocythosis (≥ 14.000/mm3) or thrombocytopenia (≤50.000/mm3)
- •Previous bleeding diathesis
- •Need for hematopoietic growth factor treatment (e.g. erythropoetin, G-CSF)
- •Impossibility of aspiration 240ml of bone marrow
- •Hepathopathy or cirrhosis (bilirubin, ALT or AST ≥ 2,5x upper limit of normal)
- •Terminal renal insufficiency or haemodyalysis
- •Uncontrolled hypertension
- •Need for high dose (> 7.5mg/day) corticotherapy within the next 6 months
- •Inability to stop anticoagulation therapy (>72 hours) before bone marrow aspiration
- •Known malignancies requiring actino or chemotherapy, or previous actinotherapy
- •Patients with a BMI >40
- •Known allergy to contrast agents
- •Other comorbidities with a life expectancy of 6 months
研究组 & 干预措施
Bone marrow autologous cells concentrate (BMAC)
retrograde administration on non-selected BMAC via coronary sinus
干预措施: BMAC (Drug)
Control
standard treatment o heart failure
干预措施: BMAC (Drug)
结局指标
主要结局
Left ventricular end-systolic volume (LVESV)
时间窗: 12 month
Left ventricular end-systolic volume
Left ventricular end-systolic diameter (LVESd)
时间窗: 12 month
Left ventricular end-systolic diameter
Left ventricular end-diastolic volume (LVEDV)
时间窗: 12 month
Left ventricular end-diastolic volume
Left ventricular end-diastolic diameter (LVEDd)
时间窗: 12 month
Left ventricular end-diastolic diameter
ejection fraction of left ventricle (EF LV)
时间窗: 12 month
ejection fraction of left ventricle
次要结局
- corridor walk test(12 month)
- QoL(12 month)