Pilot Study of COR-1 in Heart Failure

Corimmun

Status and phase: Completed; Phase 2

Conditions: Cardiomyopathy, Dilated

Treatments: Drug: COR-1; Drug: 0.9 % sodium chloride; Drug: Standard therapy for heart failure

Study type: Interventional

Funder types: Industry

Identifiers

NCT01391507

CR100913

2010-022579-68 (EudraCT Number)

COR-1/02

Details and patient eligibility

About

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.

Full description

In patients with dilated cardiomyopathy (heart is weakened and enlarged), the presence of anti-beta1-receptor autoantibodies has been shown to predict more depressed left ventricular function, increased prevalence of serious ventricular arrhythmias, sudden cardiac death, and cardiovascular mortality. In animal models, COR-1 cyclopeptide has been shown to bind to, and therefore decrease, the anti-beta1-receptor autoantibody titre. This study will investigate the safety and effectiveness of COR-1 treatment in patients with dilated cardiomyopathy. This study will be a randomized (the study treatment is assigned by chance), double-blind, (neither investigator nor patient knows the treatment that the volunteer receives), multicenter (study is conducted in more than one center) placebo-controlled (one of the treatments is inactive), parallel group study (patients in different treatment groups receive medication at the same time) in men and women who have heart failure due to dilated cardiomyopathy. Eligible patients should also have a left ventricular ejection fraction of less than or equal to 45% (measurement of the percentage of blood leaving the heart each time it contracts) and should be positive for anti-beta1-receptor autoantibodies. The study will consist of 3 phases: a screening phase, a double-blind treatment period, and a follow-up phase. Patients will be randomly assigned to 1 of 4 treatment groups: 20 mg COR-1, 80 mg COR-1, 160 mg COR-1, or placebo (inactive medication). Each patient will receive 1 intravenous dose (medication is injected into a vein) every 4 weeks for a total of 6 months. Patients will come to the study center each time they receive study medication and will remain at the center for 2 to 3 hours following the injection. Blood samples will be drawn at time points during the screening, treatment, and follow-up periods. Patients will return to the study center for follow-up visits at 3 months following completion of the 6-month treatment period. Patients will participate in the study for approximately 9 months. Patient safety will be monitored. The study drug (COR-1) is being investigated for the treatment of heart failure.

Enrollment: 36 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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36 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: 0.9 % sodium chloride

Drug: Standard therapy for heart failure

20 mg COR-1

Experimental group

Treatment:

Drug: Standard therapy for heart failure

Drug: COR-1

80 mg COR-1

Experimental group

Treatment:

Drug: Standard therapy for heart failure

Drug: COR-1

160 mg COR-1

Experimental group

Treatment:

Drug: Standard therapy for heart failure

Drug: COR-1