Phase II Study of the Effect of CK-1827452 Injection on Myocardial Efficiency - Tabular View

Tracking Information
First Received Date ^ICMJE	April 21, 2008
Last Updated Date	July 30, 2009
Start Date ^ICMJE	September 2008
Primary Completion Date	November 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 4, 2008)	To evaluate the effect of CK-1827452 on myocardial efficiency, defined as the ratio of ventricular performance to myocardial oxygen consumption. [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00748579 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 4, 2008)	To evaluate the effects of CK-1827452 on ventricular performance, myocardial oxygen consumption, pressure-volume relationships, systolic ejection time and invasively measured hemodynamics, including filling pressures and cardiac output. [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Phase II Study of the Effect of CK-1827452 Injection on Myocardial Efficiency
Official Title ^ICMJE	A Phase II Open-Label Study to Investigate the Effects of CK-1827452 Injection on Ventricular Performance, Myocardial Oxygen Consumption, and Myocardial Efficiency in Patients With Heart Failure and Left Ventricular Systolic Dysfunction
Brief 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.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics/Dynamics Study
Condition ^ICMJE	Heart Failure
Intervention ^ICMJE	Drug: CK-1827452
Study Arms / Comparison Groups	Experimental: 0.5 hour loading dose followed by 1.0 hour maintenance dose of CK-1827452 Experimental: ≤ 1.0 hour loading dose followed by 1.0 hour maintenance dose of CK-1827452
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Estimated Enrollment ^ICMJE	18
Completion Date
Primary Completion Date	November 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Canada

Administrative Information
NCT ID ^ICMJE	NCT00748579
Responsible Party	Andrew Wolff, M.D., F.A.C.C., Chief Medical Officer, Cytokinetics, Inc.
Study ID Numbers ^ICMJE	CY 1124
Study Sponsor ^ICMJE	Cytokinetics
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Cytokinetics
Verification Date	July 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP