Pilot Study of COR-1 in Heart Failure
Condition: Cardiomyopathy, Dilated
MeSH terms: Heart Failure; Cardiomyopathies; Cardiomyopathy, Dilated
Study type: Interventional
Phase: Phase 2

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.
    

Detailed 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.
    

Intervention name(s): 0.9 % sodium chloride; COR-1; Standard therapy for heart failure
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Monthly intravenous injection for 6 months; Monthly intravenous injection for 6 months; All patients will continue to receive standard therapy for heart failure (ie, in accordance with guidelines) throughout the study.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Anti-beta1-receptor autoantibodies; COR-1; Heart failure