Randomised controlled trial to compare the effects of granulocyte-colony stimulating factor (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 (UK)0 个研究点目标入组 300 人开始时间: 2005年11月23日最近更新: 2015年1月13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 a heart failure clinic for optimisation of their heart failure medication or who are on optimal heart failure treatment under supervision from their physician.

•1. Recent acute coronary sydrome as judged by a rise of troponin above normal values in the last 6 months
•2. The presence of cardiogenic shock
•3. The presence of acute left and/or right-sided pump failure as judged by the presence of pulmonary oedema and/or new peripheral oedema
•4. Known severe pre-existent left ventricular dysfunction (ejection fraction <10% prior to randomisation)
•5. Congenital cardiac disease
•6. Cardiomyopathy secondary to a reversible cause e.g. thyroid disease, alcohol abuse, hypophosphataemia, hypocalcaemia, cocaine abuse, selenium toxicity and chronic uncontrolled tachycardia
•7. Cardiomyopathy in association with a neuromuscular disorder e.g. Duchenne's progressive muscular dystrophy
•8. Contra-indication for bone marrow aspiration
•9. Known active infection
•10. Known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)
•11. Lifestyle with high risk for infection with HIV, HBV, or HCV
•12. Chronic inflammatory disease
•13. Serious known concomitant disease with a life expectancy of less than one year
•14. Follow-up impossible (no fixed abode etc.)
•15. Previous participation in this study
•16. Female subjects of childbearing potential
•17. Paced rhythm >80% of the time
•18. Serum creatinine >200 mg/dl

发起方

Barts and the London NHS Trust (UK)