Status:
COMPLETED
A Study of CK-1827452 Infusion in Stable Heart Failure
Lead Sponsor:
Cytokinetics
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study will assess the safety, tolerability, and pharmacodynamics of CK-1827452 infusion in patients with stable heart failure.
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Patient is male, or female of non-childbearing potential (two years post-menopausal or surgically sterilized)
- Female patients must have a negative urine pregnancy test prior to entry into the study
- Patient is 18 years old or greater
- Patient has given signed informed consent
- Patient is considered to be in suitable health in the opinion of the investigator, as determined by:
- 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
- An electrocardiogram (ECG) with no abnormalities in the opinion of the investigator that would impair assessment of stopping criteria
- Patient has pre-study clinical laboratory findings that are within normal range, or if outside of the normal range, should not preclude participation in the study in the opinion of the investigator (see Exclusion Criteria, below, for exceptions)
- Patient has a documented diagnosis of heart failure with an ejection fraction of less than 40%
- Patient has been on a stable dose of a beta blocker and an ACE (angiotensin-converting enzyme) inhibitor or an ARB (angiotensin II receptor blocker) for at least 4 weeks. If prescribed, diuretics must have been administered according to a consistent regimen for at least 4 weeks
- Patient is currently in sinus rhythm
- Patient has interpretable echocardiographic images on a screening echocardiogram
- Exclusion Criteria
- Patient has been hospitalized for heart failure, myocardial infarction, coronary revascularization, or another cardiac indication within the last 6 weeks
- Patient has a current history of alcohol use which in the opinion of the investigator would preclude participation in the study
- Patient has a current history of drug abuse
- Patient has donated blood or blood products within 30 days prior to screening
- Patient has Canadian Cardiovascular Society (CCS) Class III or IV angina
- Patient has significant obstructive valvular disease or significant congenital heart disease
- Patient has had a valve replacement
- Patient is pacemaker dependent
- Patient is on chronic anti-arrhythmic therapy, with the exception of amiodarone
- Patient is currently taking, or has taken in the last 7 days, a CYP3A4 inhibitor or inducer medication
- Patient has a history of hypertrophic obstructive cardiomyopathy
- Patient weighs \> 120 kg
- Patient has a supine resting systolic blood pressure \< 95 mmHg after 3 minutes rest
- Patient has a supine resting heart rate ≥ 100 beats per minute after 3 minutes rest
- Patient has an Modification of Diet in Renal Disease (MDRD) estimate of Glomerular Filtration Rate (GFR) ≤ 35 ml/min/1.73 m2
- Patient has a potassium \< 3.5 mEq/L or \> 5.5 mEq/L
- Patient has a sodium ≤ 133 mEq/L
- Patient has a urea \> 15 mmole/L
- Patient has a troponin I or T at screening that is detectable at the investigative site's clinical laboratory
- Patient has a hemoglobin \< 11 gm/dL in males or \< 10 gm/dL in females
- Patient has an alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALKP) or total bilirubin (TBILI) \> 3 times the upper limit of normal
- Patient is, in the opinion of the investigator, not suitable to participate in the study
- Patient has participated in any clinical study with an investigational drug within three months prior to the first day of dosing with the exception of coronary stent studies Patient has ever received CK-1827452
Exclusion
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00624442
Start Date
April 1 2007
End Date
February 1 2009
Last Update
May 14 2021
Active Locations (17)
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1
University of California, San Diego Medical Center
San Diego, California, United States, 92103
2
Christiana Care Health Services, Inc.
Newark, Delaware, United States, 19713
3
Diagnostic Services Clinic
Tbilisi, Georgia
4
Russian Cardiological Research and Production Complex
Moscow, Russia, 121552