A Study of CK-1827452 Infusion in Stable Heart Failure

Completed · Phase 2 · Has a placebo group

Conditions studied: Heart Failure

In brief

This study will assess the safety, tolerability, and pharmacodynamics of CK-1827452 infusion in patients with stable heart failure.

Key facts

Study ID: NCT00624442
Run by: Cytokinetics
People needed: 45
Starts: 2007-04-01
Expected to finish: 2009-02-01
Last updated by the study team: 2021-05-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

University of California, San Diego Medical Center — San Diego, California, United States
Christiana Care Health Services, Inc. — Newark, Delaware, United States
Diagnostic Services Clinic — Tbilisi, Georgia
Russian Cardiological Research and Production Complex — Moscow, Russia
Dzhanelidze Research Institute for Emergency Medical Care — Saint Petersburg, Russia
Almazov Federal Heart, Blood and Endocrinology Center — Saint Petersburg, Russia
St. Petersburg State Medical University — Saint Petersburg, Russia
Castle Hill Hospital, University of Hull — Hull, England, United Kingdom
King's College Hospital — London, England, United Kingdom
St. George's Hospital — London, England, United Kingdom
St. Mary's Hospital & Imperial College — London, England, United Kingdom
Manchester Heart Centre, Manchester Royal Infirmary — Manchester, England, United Kingdom
ICON Development Solutions — Manchester, England, United Kingdom
Wythenshawe Hospital — Manchester, England, United Kingdom
Northwick Park Hospital — Middlesex, England, United Kingdom
Ninewells Hospital and Medical School — Dundee, Scotland, United Kingdom
BHF Cardiovascular Centre — Glasgow, Scotland, United Kingdom

Full record on ClinicalTrials.gov

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