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

Cytokinetics

Status and phase

Terminated

Phase 2

Conditions

Heart Failure

Treatments

Drug: CK-1827452

Study type

Interventional

Funder types

Industry

Identifiers

NCT00748579

CY 1124

Details and patient eligibility

About

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.

Enrollment

2 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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