Clinical trial NCT00748579: Phase II Study of the Effect of CK-1827452 Injection on Myocardial Efficiency
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Heart Failure
Lead sponsor: Cytokinetics
Sponsor class: INDUSTRY
First posted: 2008-09-08
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Effect of CK-1827452 on Myocardial Efficiency, Defined as the Ratio of Ventricular Performance to Myocardial Oxygen Consumption.
timeFrame: 1 day
Secondary outcomes:
measure: Effects of CK-1827452 on Ventricular Performance
timeFrame: 1 day
measure: Effects of CK-1827452 on Myocardial Oxygen Consumption
timeFrame: 1 day
measure: Effects of CK-1827452 on Pressure-volume Relationships
timeFrame: 1 day
measure: Effects of CK-1827452 on Systolic Ejection Time
timeFrame: 1 day
measure: Effects of CK-1827452 on Invasively Measured Hemodynamics, Including Filling Pressure and Cardiac Output
timeFrame: 1 day
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Medical Institutions
state: Maryland
city: Salt Lake City
country: United States
facility: UUHSC / Division of Cardiology
state: Utah
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
References: