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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00748579
Recruitment Status : Terminated (Decision to discontinue due to challenges of trial design and constraints on enrolling eligible and consenting patients.)
First Posted : September 8, 2008
Results First Posted : August 23, 2010
Last Update Posted : January 21, 2020
Sponsor:
Information provided by (Responsible Party):
Cytokinetics

Tracking Information
First Submitted Date  ICMJE April 21, 2008
First Posted Date  ICMJE September 8, 2008
Results First Submitted Date  ICMJE July 30, 2010
Results First Posted Date  ICMJE August 23, 2010
Last Update Posted Date January 21, 2020
Study Start Date  ICMJE September 2008
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 24, 2010)
Effect of CK-1827452 on Myocardial Efficiency, Defined as the Ratio of Ventricular Performance to Myocardial Oxygen Consumption. [ Time Frame: 1 day ]
Measure the effect CK-1827452 on hemodynamics and energetic measures of ventricular performance, myocardial oxygen consumption, and myocardial efficiency (the ratio of ventricular performance to myocardial oxygen consumption), in patients with clinical heart failure.
Original 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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2020)
  • Effects of CK-1827452 on Ventricular Performance [ Time Frame: 1 day ]
    Measure the effect of CK-1824752 on ventricular performance
  • Effects of CK-1827452 on Myocardial Oxygen Consumption [ Time Frame: 1 day ]
    Measure the effect of CK-1824752 on myocardial oxygen consumption
  • Effects of CK-1827452 on Pressure-volume Relationships [ Time Frame: 1 day ]
    Measure the effect of CK-1824752 on pressure-volume relationships
  • Effects of CK-1827452 on Systolic Ejection Time [ Time Frame: 1 day ]
    Measure the effect of CK-1824752 on systolic ejection time
  • Effects of CK-1827452 on Invasively Measured Hemodynamics, Including Filling Pressure and Cardiac Output [ Time Frame: 1 day ]
    Measure the effect of CK-1824752 on invasively measured hemodynamics, including filling pressure and cardiac output
Original 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Heart Failure
Intervention  ICMJE
  • Drug: CK-1827452
    I.V. infusion for 0.5 hour at 54mg/hr followed by 1 hour at 21mg/hr
  • Drug: CK-1827452
    I.V. infusion for ≤ 1 hour at 72mg/hr followed by 1 hour at 36mg/hr
Study Arms  ICMJE
  • Experimental: Cohort 1
    0.5 hour loading dose followed by 1.0 hour maintenance dose of CK-1827452
    Intervention: Drug: CK-1827452
  • Experimental: Cohort 2
    ≤ 1.0 hour loading dose followed by 1.0 hour maintenance dose of CK-1827452
    Intervention: Drug: CK-1827452
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 30, 2010)
2
Original Estimated Enrollment  ICMJE
 (submitted: September 4, 2008)
18
Actual Study Completion Date  ICMJE July 2009
Actual 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00748579
Other Study ID Numbers  ICMJE CY 1124
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cytokinetics
Study Sponsor  ICMJE Cytokinetics
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Cytokinetics
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP