Heart Failure Clinical Trial
A Study of CK-1827452 Infusion in Stable Heart Failure
Summary
This study will assess the safety, tolerability, and pharmacodynamics of CK-1827452 infusion in patients with stable heart failure.
Eligibility Criteria
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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 16 Locations for this study
San Diego California, 92103, United States
Newark Delaware, 19713, United States
Tbilisi , , Georgia
Moscow , 12155, Russian Federation
St. Petersburg , 19224, Russian Federation
St. Petersburg , 19415, Russian Federation
St. Petersburg , 19708, Russian Federation
Hull England, HU16 , United Kingdom
London England, SE5 9, United Kingdom
London England, SW17 , United Kingdom
London England, W2 1L, United Kingdom
Manchester England, M13 9, United Kingdom
Manchester England, M15 6, United Kingdom
Manchester England, M23 9, United Kingdom
Middlesex England, HA1 3, United Kingdom
Dundee Scotland, DD1 9, United Kingdom
Glasgow Scotland, G12 8, United Kingdom
How clear is this clinincal trial information?

Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.