COR-1 in heart failure

• Conditions: Heart Failure, Dilated Cardiomyopathy; MedDRA version: 14.1Level: LLTClassification code 10056419Term: Dilated cardiomyopathySystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2010-022579-68-DE
• Lead Sponsor: Corimmun GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-30
• Last Update Posted: 16 September 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- 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

Exclusion Criteria

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified