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

NCT ID: NCT00748579

Last Updated: 2020-01-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2009-07-31

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.

Conditions

Heart Failure

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1

0.5 hour loading dose followed by 1.0 hour maintenance dose of CK-1827452

Group Type: EXPERIMENTAL

CK-1827452

Intervention Type: DRUG

I.V. infusion for 0.5 hour at 54mg/hr followed by 1 hour at 21mg/hr

Cohort 2

≤ 1.0 hour loading dose followed by 1.0 hour maintenance dose of CK-1827452

Group Type: EXPERIMENTAL

CK-1827452

Intervention Type: DRUG

I.V. infusion for ≤ 1 hour at 72mg/hr followed by 1 hour at 36mg/hr

Interventions

CK-1827452

I.V. infusion for 0.5 hour at 54mg/hr followed by 1 hour at 21mg/hr

Intervention Type: DRUG

CK-1827452

I.V. infusion for ≤ 1 hour at 72mg/hr followed by 1 hour at 36mg/hr

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cytokinetics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Johns Hopkins Medical Institutions

Baltimore, Maryland, United States

UUHSC / Division of Cardiology

Salt Lake City, Utah, United States

Mount Sinai Hospital

Toronto, Ontario, Canada

Countries

United States; Canada

Other Identifiers

CY 1124

Identifier Type: -

Identifier Source: org_study_id