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

This study has been terminated.
(Decision to discontinue was due to the challenges of the trial design and the constraints on enrolling eligible and consenting patients.)
Sponsor:
Information provided by:
Cytokinetics
ClinicalTrials.gov Identifier:
NCT00748579
First received: April 21, 2008
Last updated: August 24, 2010
Last verified: August 2010
  Purpose

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.


Condition Intervention Phase
Heart Failure
Drug: CK-1827452
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Cytokinetics:

Primary Outcome Measures:
  • 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 ]
    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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 2
Study Start Date: September 2008
Study Completion Date: July 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
0.5 hour loading dose followed by 1.0 hour maintenance dose of CK-1827452
Drug: CK-1827452
I.V. infusion for 0.5 hour at 54mg/hr followed by 1 hour at 21mg/hr
Experimental: Cohort 2
≤ 1.0 hour loading dose followed by 1.0 hour maintenance dose of CK-1827452
Drug: CK-1827452
I.V. infusion for ≤ 1 hour at 72mg/hr followed by 1 hour at 36mg/hr

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00748579

Locations
United States, Maryland
Johns Hopkins Medical Institutions
Baltimore, Maryland, United States, 21205
United States, Utah
UUHSC / Division of Cardiology
Salt Lake City, Utah, United States, 84132
Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Sponsors and Collaborators
Cytokinetics
  More Information

No publications provided

Responsible Party: Andrew Wolff, M.D., F.A.C.C., Chief Medical Officer, Cytokinetics, Inc.
ClinicalTrials.gov Identifier: NCT00748579     History of Changes
Other Study ID Numbers: CY 1124
Study First Received: April 21, 2008
Results First Received: July 30, 2010
Last Updated: August 24, 2010
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 30, 2014