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 current trial design and the constraints on enrolling eligible and consenting patients. )

First Received: April 21, 2008 Last Updated: July 30, 2009 History of Changes

Sponsor:	Cytokinetics
Information provided by:	Cytokinetics
ClinicalTrials.gov Identifier:	NCT00748579

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 II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics/Dynamics Study
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:

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Further study details as provided by Cytokinetics:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	18
Study Start Date:	September 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Cohort 1: Experimental 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
Cohort 2: Experimental ≤ 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

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:	Cytokinetics, Inc. ( Andrew Wolff, M.D., F.A.C.C., Chief Medical Officer )
Study ID Numbers:	CY 1124
Study First Received:	April 21, 2008
Last Updated:	July 30, 2009
ClinicalTrials.gov Identifier:	NCT00748579 History of Changes
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 November 22, 2009