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

NCT00748579 | Terminated Phase 2 Results DMC

• 1 other identifier: CY 1124
• Study Type: interventional
• Target: 2
• Locations: 2 countries
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• Effect of CK-1827452 on Myocardial Efficiency, Defined as the Ratio of Ventricular Performance to Myocardial Oxygen Consumption.

  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.

  1 day

Secondary Outcomes (5)

• Effects of CK-1827452 on Ventricular Performance

  1 day

• Effects of CK-1827452 on Myocardial Oxygen Consumption

  1 day

• Effects of CK-1827452 on Pressure-volume Relationships

  1 day

• Effects of CK-1827452 on Systolic Ejection Time

  1 day

• Effects of CK-1827452 on Invasively Measured Hemodynamics, Including Filling Pressure and Cardiac Output

  1 day

Study Arms (2)

Cohort 1

EXPERIMENTAL

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

Drug: CK-1827452

Cohort 2

EXPERIMENTAL

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

Drug: CK-1827452

Interventions

CK-1827452 DRUG

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

Cohort 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cytokinetics: lead

Study Sites (3)

Johns Hopkins Medical Institutions

Baltimore, Maryland, 21205, United States

Location

UUHSC / Division of Cardiology

Salt Lake City, Utah, 84132, United States

Location

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

MeSH Terms

Conditions

Heart Failure

Interventions

omecamtiv mecarbil

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Limitations and Caveats

Inadequate enrollment led to early termination of study and insufficient number of patients for analysis.

Results Point of Contact

• Title: Medical Director
• Organization: Cytokinetics, Inc.

(650) 624-3011

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2008
• First Posted: September 8, 2008
• Study Start: September 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: July 1, 2009
• Last Updated: January 21, 2020
• Results First Posted: August 23, 2010

Record last verified: 2020-01

Locations

US (2); CA (1)