Randomised Control Trial To Compare The Effects Of G-CSF And Autologous Bone Marrow Progenitor Cells Infusion On Quality Of Life And Left Ventricular Function In Patients With Heart Failure Secondary to Ischaemic Heart Disease

Barts and the London NHS Trust, Department of Cardiology0 个研究点目标入组 300 人开始时间: 2005年6月15日最近更新: 2015年8月4日

适应症

试验速览

暂无简介。

•Patients with a diagnosis of heart failure secondary to ischaemic heart disease attending the 'Heart Failure clinic' for optimisation of their heart failure medication or who are on optimal heart failure treatment under supervision from their physician
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Recent acute coronary syndrome as judged by a rise of Troponin above normal values in the last 6 months
•The presence of cardiogenic shock
•The presence of acute left and/or right-sided pump failure as judged by the presence of pulmonary oedema and/or new peripheral oedema
•Known severe pre-existent left ventricular dysfunction (ejection fraction < 10% prior to randomisation)
•Congenital cardiac disease
•Cardiomyopathy 2o to a reversible cause e.g. thyroid disease, alcohol abuse, hypophosphataemia, hypocalcaemia, cocaine abuse, selenium toxicity & chronic uncontrolled tachycardia
•Cardiomyopathy in association with a neuromuscular disorder e.g. Duchenne's progressive muscular dystrophy
•Contra-indication for bone marrow aspiration
•Known active infection
•Known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)
•Lifestyle with high risk for infection with HIV, HBV or HCV
•Chronic inflammatory disease
•Serious known concomitant disease with a life expectancy of less than one year
•Follow-up impossible (no fixed abode, etc)
•Previous participation in this study
•Female subjects of childbearing potential
•Patients with a ventricular pacemaker who are in a paced rhythm for >80% of the time

发起方

Barts and the London NHS Trust, Department of Cardiology