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

Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00748579
• Other study ID #: CY 1124
• Status: Terminated
• Phase: Phase 2
• Start date: September 2008
• Est. completion date: July 2009

Study information

• Verified date: January 2020
• Source: Cytokinetics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: July 2009
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Drug:
• CK-1827452
I.V. infusion for 0.5 hour at 54mg/hr followed by 1 hour at 21mg/hr
• CK-1827452
I.V. infusion for = 1 hour at 72mg/hr followed by 1 hour at 36mg/hr

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario
United States	Johns Hopkins Medical Institutions	Baltimore	Maryland
United States	UUHSC / Division of Cardiology	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Cytokinetics

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Effects of CK-1827452 on Ventricular Performance	Measure the effect of CK-1824752 on ventricular performance	1 day
Secondary	Effects of CK-1827452 on Myocardial Oxygen Consumption	Measure the effect of CK-1824752 on myocardial oxygen consumption	1 day
Secondary	Effects of CK-1827452 on Pressure-volume Relationships	Measure the effect of CK-1824752 on pressure-volume relationships	1 day
Secondary	Effects of CK-1827452 on Systolic Ejection Time	Measure the effect of CK-1824752 on systolic ejection time	1 day
Secondary	Effects of CK-1827452 on Invasively Measured Hemodynamics, Including Filling Pressure and Cardiac Output	Measure the effect of CK-1824752 on invasively measured hemodynamics, including filling pressure and cardiac output	1 day