Pilot Study of COR-1 in Heart Failure

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate the effect of COR-1 in combination with standard therapy in patients with heart failure. The safety and tolerability of COR-1 will also be assessed.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Corimmun GmbH

Criteria

Inclusion Criteria:

• Diagnosed heart failure due to dilated cardiomyopathy with left ventricular ejection fraction < 45%

• Presence of anti-beta1-receptor autoantibodies

• New York Heart Association (NYHA) class II to III heart failure

• Symptomatic heart failure for >1 year and < 8 years

• Treatment with adequate doses of angiotensin converting enzyme inhibitors or angiotensin II receptor blockers, beta-blockers, and optional aldosterone antagonists according to guidelines for at least six months (with the exception of lack of tolerability of any of these drugs) and at stable doses for 2 months prior to screening

Exclusion Criteria:

• Ischemic heart disease characterized by >= 50% coronary artery stenosis and/or history of myocardial infarction

• Third or higher degree valvular defect

• Any disease requiring immunosuppressive drugs (except for <= 5 mg/day prednisone-equivalent dose) or any clinically relevant disorder of the immune system

• History of severe allergies and increased risk for anaphylactic shock (e.g., bronchial asthma)

• History of, or currently active illness, considered to be clinically significant by the Investigator or any other illness that the Investigator considers should exclude the patient from the study or that could interfere with the interpretation of the study results