Phase II Study of the Effect of CK-1827452 Injection on Myocardial Efficiency
Condition: Heart Failure
MeSH terms: Heart Failure
Intervention: CK-1827452; CK-1827452
Intervention description: I.V. infusion for 0.5 hour at 54mg/hr followed by 1 hour at 21mg/hr; I.V. infusion for ≤ 1 hour at 72mg/hr followed by 1 hour at 36mg/hr
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose for this study (CY 1124) is to evaluate the effects of CK-1827452, a cardiac
      myosin activator, on myocardial systolic performance, myocardial oxygen consumption, and
      myocardial efficiency in patients with heart failure and to confirm that the unique
      preclinical pharmacological profile of CK- 1827452 is substantially the same in patients with
      heart failure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical indication for left and right heart catheterization

          -  Willing and able to provide informed consent

          -  Male or female 18 years of age or greater

          -  Symptomatic heart failure (≥ NYHA Class II)

          -  Ejection fraction ≤ 35%

          -  Patient is in sinus rhythm

          -  Patient is considered to be in suitable health in the opinion of the investigator, as
             determined by:

             o A pre-study physical examination with no clinical abnormalities which in the opinion
             of the investigator would preclude participation in the study other than physical
             symptoms or signs consistent with stable heart failure

          -  For female patients only: Post-menopausal or sterilized, or if she is of childbearing
             potential, she is not breastfeeding, her pregnancy test is negative, she has no
             intention to become pregnant for up to 90 days following the study, and she is using
             contraceptive drugs or devices

        Exclusion Criteria:

          -  Acute myocarditis

          -  Hypertrophic, restrictive, or constrictive cardiomyopathy

          -  Congenital heart disease

          -  Known left ventricular thrombus

          -  Significant stenotic valvular disease (severe aortic stenosis, mitral stenosis)

          -  Poorly controlled hypertension (SBP > 180 mmHg)

          -  Pacemaker dependent ventricular rhythm

          -  Detectable troponin or CK-MB > ULN at any timepoint within 14 days of enrollment

          -  Acute coronary syndrome or revascularization procedure within 30 days of enrollment

          -  ≥ 50% stenosis of the left main coronary artery

          -  Plan for immediate revascularization procedure (PCI or CABG)

          -  GFR ≤ 35 ml/min/1.73 m2 by Modification of Diet in Renal Disease (MDRD) Equation or
             need for renal replacement therapy

          -  Known hepatic impairment (total bilirubin > 3 mg/dL, or ALT and AST > 2 times the
             upper limit of normal)

          -  Has received an investigational drug or device within 30 days before enrollment

          -  Has had any prior treatment with CK-1827452