COR-1, an anti-ß1 receptor antibody cyclopeptide in heart failure: a phase II, multicentre, randomised, double-blind and placebo-controlled study with parallel groups - COR-1 in heart failure

Corimmun GmbH0 个研究点开始时间: 2011年5月30日最近更新: 2013年9月16日

适应症

试验速览

暂无简介。

•- Diagnosed heart failure due to dilated cardiomyopathy
•- presence of anti-ß1-adrenoreceptor autoantibodies in patients` blood samples
•- LVEF < 45%, as determined by biplane echocardiography
•- New York Heart Association (NYHA) class II – III
•- disease duration: symptomatic heart failure for >1 year and <8 years
•- Treatment with ACE inhibitors or angiotensin II receptor blockers (ARB), beta-blockers and aldosterone antagonists (the latter at the discretion of the attending physician) according to 2012 European Society of Cardiology guidelines for at least 6 months (with the exception of lack of tolerability of any of these drugs) and at stable doses for at least 2 months prior to screening (Note: standard therapy” can include, but does not have to include, any of the following: ACE inhibitor, angiotensin II receptor blockers (ARB) or beta-blocker.)
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 40
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•- Ischemic heart disease characterised by = 50% coronary artery stenosis and/or history of myocardial infarction as determined by coronary angiography
•- Third or higher degree valvular defect
•- Clinically relevant disorder of the immune system (as determined by anamnesis)
•- History of severe allergies, increased risk for anaphylactic shock (as determined by anamnesis e.g. bronchial asthma)
•- Any disease requiring immunosuppressive drugs, except = 5 mg/day prednisone equivalent dose

发起方