A Study of CK-1827452 Infusion in Stable Heart Failure

A Phase 2 study testing CK-1827452 in people with Heart Failure, run by Cytokinetics at 17 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Heart Failure
What is being tested?: CK-1827452
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 45 participants
Where: 17 sitesin 4 countries
Study dates: Apr 2007to Feb 2009
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 12Show fewer

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

Who cannot join

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

Show all 23Show fewer

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

Trial locations and contacts

17 sites in 4 countries.

Country

City, postcode or hospital

17 sites in 4 countries

United Kingdom10 sites

Ninewells Hospital and Medical School
Dundee, Scotland, DD1 9SY
BHF Cardiovascular Centre
Glasgow, Scotland, G12 8TA
Castle Hill Hospital, University of Hull
Hull, England, HU16 5JQ
King's College Hospital
London, England, SE5 9RS
St. George's Hospital
London, England, SW17 ORE
St. Mary's Hospital & Imperial College
London, England, W2 1LA
Manchester Heart Centre, Manchester Royal Infirmary
Manchester, England, M13 9WL
ICON Development Solutions
Manchester, England, M15 6SH
Wythenshawe Hospital
Manchester, England, M23 9LT
Northwick Park Hospital
Middlesex, England, HA1 3UJ

Other trials in United Kingdom

Russia4 sites

Russian Cardiological Research and Production Complex
Moscow, 121552
Dzhanelidze Research Institute for Emergency Medical Care
Saint Petersburg, 192242
Almazov Federal Heart, Blood and Endocrinology Center
Saint Petersburg, 194156
St. Petersburg State Medical University
Saint Petersburg, 197089

Other trials in Russia

United States2 sites

Christiana Care Health Services, Inc.
Newark, Delaware, 19713
University of California, San Diego Medical Center
San Diego, California, 92103

Other trials in United States

Georgia1 site

Diagnostic Services Clinic
Tbilisi

Other trials in Georgia

About this study

Official title: A Phase II, Multi Center, Double-Blind, Randomized, Placebo Controlled, Dose-Escalation, Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of CK-1827452 in Patients With Stable Heart Failure

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

Conditions: Heart Failure
Being tested: CK-1827452, Placebo
Medical subject headings: Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CK-1827452Drug
IV infusion for 1 hour at 0.125 mg/kg/h followed by 1 hour at 0.0625 mg/kg/h
CK-1827452Drug
IV infusion for 1 hour at 0.25 mg/kg/h followed by 1 hour at 0.125 mg/kg/h
CK-1827452Drug
IV infusion for 1 hour at 0.5 mg/kg/h followed by 1 hour at 0.25 mg/kg/h
CK-1827452Drug
IV infusion for 1 hour at 0.75 mg/kg/h followed by 1 hour at 0.375 mg/kg/h
CK-1827452Drug
IV infusion for 1 hour at 1.0 mg/kg/h followed by 1 hour at 0.5 mg/kg/h
CK-1827452Drug
IV infusion for 1 hour at 0.25 mg/kg/h followed by 1 hour at 0.125 mg/kg/h followed by 22 hours at 0.025 mg/kg/h
CK-1827452Drug
IV infusion for 1 hour at 0.5 mg/kg/h followed by 1 hour at 0.25 mg/kg/h followed by 22 hours at 0.05 mg/kg/h
CK-1827452Drug
IV infusion for 1 hour at 1.0 mg/kg/h followed by 1 hour at 0.5 mg/kg/h followed by 22 hours at 0.1 mg/kg/h
PlaceboDrug
IV infusion for 2 hours
PlaceboDrug
IV infusion for 24 hours
CK-1827452Drug
IV infusion for 1 hour at 1.0 mg/kg/h followed 1 hour at 0.5 mg/kg/h followed by 70 hours at 0.1 mg/kg/h
PlaceboDrug
IV infusion for 72 hours
CK-1827452Drug
IV infusion for 1 hour at 0.75 mg/kg/h followed 1 hour at 0.5 mg/kg/h followed by 70 hours at 0.1 mg/kg/h
CK-1827452Drug
IV infusion for 1 hour at 0.25 mg/kg/h followed by 23 hours at 0.025 mg/kg/h
CK-1827452Drug
IV infusion for 1 hour at 0.5 mg/kg/h followed by 23 hours at 0.05 mg/kg/h
CK-1827452Drug
IV infusion for 1 hour at 1.0 mg/kg/h followed by 23 hours at 0.1 mg/kg/h

Study groups in NCT00624442
Study group	Role	What they receive
Cohort 1	Experimental	4 treatment periods with a 2 hour infusion. The 4 treatment periods consist of 3 escalating dose levels of CK-1827452 and 1 placebo treatment randomized into the dose escalation sequence. Treatment periods occur at least 7 days apart. Receives: Drug: CK-1827452; Drug: Placebo
Cohort 2	Experimental	4 treatment periods with a 2 hour infusion. The 4 treatment periods consist of 3 escalating dose levels of CK-1827452 and 1 placebo treatment randomized into the dose escalation sequence. Treatment periods occur at least 7 days apart. Receives: Drug: CK-1827452; Drug: Placebo
Cohort 3	Experimental	4 treatment periods with a 24 hour infusion. The 4 treatment periods consist of 3 escalating dose levels of CK-1827452 and 1 placebo treatment randomized into the dose escalation sequence. Treatment periods occur at least 7 days apart. Receives: Drug: Placebo; Drug: CK-1827452
Cohort 4	Experimental	4 treatment periods with a 24 hour infusion. The 4 treatment periods consist of 3 escalating dose levels of CK-1827452 and 1 placebo treatment randomized into the dose escalation sequence. Treatment periods occur at least 7 days apart. Receives: Drug: CK-1827452; Drug: Placebo
Cohort 5	Experimental	2 treatment periods with a 72 hour infusion. The 2 treatment periods are randomly assigned and consist of 1 dose level of CK-1827452 (with dose de-escalation possible depending on tolerability) and 1 placebo treatment. Treatment period 2 occurs at least 7 days after the conclusion of period 1. Receives: Drug: CK-1827452; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline of Systolic Ejection Time at Various CK-1827452 Plasma Concentrations
Pooled analysis of the echocardiographic measure systolic ejection time from echocardiograms taken at all timepoints. The systolic ejection time is the period during which the aortic valve is open and blood is flowing across the valve. Echocardiograms from cohorts 1,2,3,4 and 5 (564 echocardiograms) were binned into either placebo group or 1 of 6 groups based on plasma concentration of CK-1827452.
Measured: 4 days
Change From Baseline of Fractional Shortening at Various CK-1827452 Plasma Concentrations
Pooled analysis of the echocardiographic measure fractional shortening from echocardiograms taken at all timepoints. Fractional shortening is the percentage of change from baseline in the left ventricular cavity dimension with systole. Echocardiograms from cohorts 1,2,3,4 and 5 (564 echocardiograms) were binned into either placebo group or 1 of 6 groups based on plasma concentration of CK-1827452.
Measured: 4 days

Secondary outcomes (2)

CK-1827452 Maximum Observed Plasma Concentration (Cmax)
Determined by evaluation of plasma concentrations from blood samples collected prior to dosing and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 and 48 hours after initiation of study drug infusion
Measured: 2 days
CK-1827452 Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Plasma Concentration (AUClast)
Determined by evaluation of plasma concentrations from blood samples collected prior to dosing and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24 and 48 hours after initiation of study drug infusion
Measured: 2 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2007Feb 2009

First posted27 Feb 2008 (estimated)
Study startApr 2007
Primary completionFeb 2009
Study completionFeb 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Heart FailureStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00624442
Sponsor's protocol ID: CY 1121
Status last verified: Apr 2021
First submitted: 21 Dec 2007
Last updated: 14 May 2021
Results posted: Yes, on ClinicalTrials.gov

Publications

Vu T, Ma P, Xiao JJ, Wang YM, Malik FI, Chow AT. Population pharmacokinetic-pharmacodynamic modeling of omecamtiv mecarbil, a cardiac myosin activator, in healthy volunteers and patients with stable heart failure. J Clin Pharmacol. 2015 Nov;55(11):1236-47. doi: 10.1002/jcph.538. Epub 2015 Jul 14.
PubMed 25951506
Cleland JG, Teerlink JR, Senior R, Nifontov EM, Mc Murray JJ, Lang CC, Tsyrlin VA, Greenberg BH, Mayet J, Francis DP, Shaburishvili T, Monaghan M, Saltzberg M, Neyses L, Wasserman SM, Lee JH, Saikali KG, Clarke CP, Goldman JH, Wolff AA, Malik FI. The effects of the cardiac myosin activator, omecamtiv mecarbil, on cardiac function in systolic heart failure: a double-blind, placebo-controlled, crossover, dose-ranging phase 2 trial. Lancet. 2011 Aug 20;378(9792):676-83. doi: 10.1016/S0140-6736(11)61126-4.
PubMed 21856481

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic

All Heart Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II, Multi Center, Double-Blind, Randomized, Placebo Controlled, Dose-Escalation, Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of CK-1827452 in Patients With Stable Heart Failure
ClinicalTrials.gov ID: NCT00624442
Acronym / sponsor ID: CY 1121
Conditions: Heart Failure
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 45 participants (actual)
Lead sponsor: CytokineticsIndustry (pharma, biotech, devices)
Study start: Apr 2007
Primary completion: Feb 2009 (actual)
Study completion: Feb 2009 (actual)
First posted: 27 Feb 2008 (estimated)
Results: Posted 16 Aug 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
Cohort 1	Experimental	Drug: CK-1827452, Drug: Placebo4 treatment periods with a 2 hour infusion. The 4 treatment periods consist of 3 escalating dose levels of CK-1827452 and 1 placebo treatment randomized into the dose escalation sequence. Treatment periods occur at least 7 days apart.
Cohort 2	Experimental	Drug: CK-1827452, Drug: Placebo4 treatment periods with a 2 hour infusion. The 4 treatment periods consist of 3 escalating dose levels of CK-1827452 and 1 placebo treatment randomized into the dose escalation sequence. Treatment periods occur at least 7 days apart.
Cohort 3	Experimental	Drug: Placebo, Drug: CK-18274524 treatment periods with a 24 hour infusion. The 4 treatment periods consist of 3 escalating dose levels of CK-1827452 and 1 placebo treatment randomized into the dose escalation sequence. Treatment periods occur at least 7 days apart.
Cohort 4	Experimental	Drug: CK-1827452, Drug: Placebo4 treatment periods with a 24 hour infusion. The 4 treatment periods consist of 3 escalating dose levels of CK-1827452 and 1 placebo treatment randomized into the dose escalation sequence. Treatment periods occur at least 7 days apart.
Cohort 5	Experimental	Drug: CK-1827452, Drug: Placebo2 treatment periods with a 72 hour infusion. The 2 treatment periods are randomly assigned and consist of 1 dose level of CK-1827452 (with dose de-escalation possible depending on tolerability) and 1 placebo treatment. Treatment period 2 occurs at least 7 days after the conclusion of period 1.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

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:

Key exclusion criteria (23 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CK-1827452IV infusion for 1 hour at 0.125 mg/kg/h followed by 1 hour at 0.0625 mg/kg/h	Drug	Cohort 1
CK-1827452IV infusion for 1 hour at 0.25 mg/kg/h followed by 1 hour at 0.125 mg/kg/h	Drug	Cohort 1
CK-1827452IV infusion for 1 hour at 0.5 mg/kg/h followed by 1 hour at 0.25 mg/kg/h	Drug	Cohort 1, Cohort 2
CK-1827452IV infusion for 1 hour at 0.75 mg/kg/h followed by 1 hour at 0.375 mg/kg/h	Drug	Cohort 2
CK-1827452IV infusion for 1 hour at 1.0 mg/kg/h followed by 1 hour at 0.5 mg/kg/h	Drug	Cohort 2
CK-1827452IV infusion for 1 hour at 0.25 mg/kg/h followed by 1 hour at 0.125 mg/kg/h followed by 22 hours at 0.025 mg/kg/h	Drug	Cohort 4
CK-1827452IV infusion for 1 hour at 0.5 mg/kg/h followed by 1 hour at 0.25 mg/kg/h followed by 22 hours at 0.05 mg/kg/h	Drug	Cohort 4
CK-1827452IV infusion for 1 hour at 1.0 mg/kg/h followed by 1 hour at 0.5 mg/kg/h followed by 22 hours at 0.1 mg/kg/h	Drug	Cohort 4
PlaceboIV infusion for 2 hours	Drug	Cohort 1, Cohort 2
PlaceboIV infusion for 24 hours	Drug	Cohort 3, Cohort 4
CK-1827452IV infusion for 1 hour at 1.0 mg/kg/h followed 1 hour at 0.5 mg/kg/h followed by 70 hours at 0.1 mg/kg/h	Drug	Cohort 5
PlaceboIV infusion for 72 hours	Drug	Cohort 5
CK-1827452IV infusion for 1 hour at 0.75 mg/kg/h followed 1 hour at 0.5 mg/kg/h followed by 70 hours at 0.1 mg/kg/h	Drug	Cohort 5
CK-1827452IV infusion for 1 hour at 0.25 mg/kg/h followed by 23 hours at 0.025 mg/kg/h	Drug	Cohort 3
CK-1827452IV infusion for 1 hour at 0.5 mg/kg/h followed by 23 hours at 0.05 mg/kg/h	Drug	Cohort 3
CK-1827452IV infusion for 1 hour at 1.0 mg/kg/h followed by 23 hours at 0.1 mg/kg/h	Drug	Cohort 3

Primary outcome

Change From Baseline of Systolic Ejection Time at Various CK-1827452 Plasma Concentrations
Time frame: 4 days
Pooled analysis of the echocardiographic measure systolic ejection time from echocardiograms taken at all timepoints. The systolic ejection time is the period during which the aortic valve is open and blood is flowing across the valve. Echocardiograms from cohorts 1,2,3,4 and 5 (564 echocardiograms) were binned into either placebo group or 1 of 6 groups based on plasma concentration of CK-1827452.
Change From Baseline of Fractional Shortening at Various CK-1827452 Plasma Concentrations
Time frame: 4 days
Pooled analysis of the echocardiographic measure fractional shortening from echocardiograms taken at all timepoints. Fractional shortening is the percentage of change from baseline in the left ventricular cavity dimension with systole. Echocardiograms from cohorts 1,2,3,4 and 5 (564 echocardiograms) were binned into either placebo group or 1 of 6 groups based on plasma concentration of CK-1827452.

2 secondary outcomes

CK-1827452 Maximum Observed Plasma Concentration (Cmax)
Time frame: 2 days
CK-1827452 Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Plasma Concentration (AUClast)
Time frame: 2 days

Results and safety

Results posted to the registry on 16 Aug 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1	8	8
Cohort 2	9	8
Cohort 3	10	8
Cohort 4	8	8
Cohort 5	10	8

Primary outcome: Change From Baseline of Systolic Ejection Time at Various CK-1827452 Plasma Concentrations

Time frame: 4 days. Least squares mean (Standard Error). Unit: msec

Measure	>0-100 ng/mL n = 32	>100-200 ng/mL n = 30	>200-300 ng/mL n = 27	>300-400 ng/mL n = 22	>400-500 ng/mL n = 17	>500 ng/mL n = 25
# of Echocardiographic Observations (no units)	84 (0)	62 (0)	42 (0)	24 (0)	20 (0)	46 (0)
Ejection Fraction msec Change from Baseline	1 (4)	18 (4)	47 (5)	58 (6)	59 (6)	80 (5)

>0-100 ng/mL: LSM placebo corrected diff from baseline: 1 (95% CI -7 to 8), p = 0.8842, ANCOVA
>100-200 ng/mL: LSM placebo corrected diff from baseline: 18 (95% CI 10 to 27), p <0.0001, ANCOVA
>200-300 ng/mL: LSM placebo corrected diff from baseline: 47 (95% CI 38 to 56), p <0.0001, ANCOVA

Population analysed: Pharmacodynamic Population. 4-way crossover design for cohorts 1-4 and 2-way crossover for cohort 5 requires multiple dosing events per participant. Also, multiple PK/PD assessments occur per dosing event.

Primary outcome: Change From Baseline of Fractional Shortening at Various CK-1827452 Plasma Concentrations

Time frame: 4 days. Least squares mean (Standard Error). Unit: Percentage of change

Measure	>0-100 ng/mL n = 31	>100-200 ng/mL n = 28	>200-300 ng/mL n = 25	>300-400 ng/mL n = 21	>400-500 ng/mL n = 14	>500 ng/mL n = 23
# of Echocardiographic Observations (no units)	81 (0)	56 (0)	37 (0)	23 (0)	17 (0)	44 (0)
Fractional Shortening Percent Change from Baseline	1 (1)	1 (1)	3 (1)	3 (1)	2 (1)	5 (1)

>0-100 ng/mL: LSM placebo corrected diff from baseline: 1 (95% CI -1 to 2), p = 0.3665, ANCOVA
>100-200 ng/mL: LSM placebo corrected diff from baseline: 1 (95% CI 0 to 3), p <0.0357, ANCOVA
>200-300 ng/mL: LSM placebo corrected diff from baseline: 3 (95% CI 1 to 5), p = 0.0004, ANCOVA

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 5 weeks. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 41 (0%)	8 of 41 (19.5%)	Not reported
Cohorts 1 and/or 2, Loading Dose of 0.125 mg/kg/hr	0 of 8 (0%)	1 of 8 (12.5%)	Not reported
Cohorts 1 and/or 2, Loading Dose of 0.25 mg/kg/hr	0 of 9 (0%)	0 of 9 (0%)	Not reported
Cohorts 1 and/or 2, Loading Dose of 0.5 mg/kg/hr	0 of 16 (0%)	1 of 16 (6.3%)	Not reported
Cohorts 1 and/or 2, Loading Dose of 1.0 mg/kg/hr	0 of 6 (0%)	4 of 6 (66.7%)	Not reported
Cohorts 1 and/or 2, Loading Dose of 0.75 mg/kg/hr	0 of 8 (0%)	0 of 8 (0%)	Not reported
Cohort 2, Loading Dose of 2.2 mg/kg/hr	1 of 1 (100%)	1 of 1 (100%)	Not reported
Cohorts 3 and 4, Loading Dose of 0.25 mg/kg/hr	1 of 18 (5.6%)	6 of 18 (33.3%)	Not reported
Cohorts 3 and 4, Loading Dose of 0.5 mg/kg/hr	1 of 18 (5.6%)	4 of 18 (22.2%)	Not reported
Cohorts 3 and 4, Loading Dose of 1.0 mg/kg/hr	0 of 16 (0%)	1 of 16 (6.3%)	Not reported
Cohort 5, Loading Dose of 0.75 mg/kg/hr	0 of 2 (0%)	1 of 2 (50%)	Not reported
Cohort 5, Loading Dose of 1.0 mg/kg/hr	0 of 8 (0%)	2 of 8 (25%)	Not reported

Limitations and caveats (from the sponsor): Other Adverse Event table shows treatment emergent adverse events that occurred in two or more patients. Total for Other Adverse Events is the number of patients affected by an adverse event where an adverse event occurred in two or more patients.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25951506Vu T, Ma P, Xiao JJ, Wang YM, Malik FI, Chow AT. Population pharmacokinetic-pharmacodynamic modeling of omecamtiv mecarbil, a cardiac myosin activator, in healthy volunteers and patients with stable heart failure. J Clin Pharmacol. 2015 Nov;55(11):1236-47. doi: 10.1002/jcph.538. Epub 2015 Jul 14.
Derived from this study: PubMed 21856481Cleland JG, Teerlink JR, Senior R, Nifontov EM, Mc Murray JJ, Lang CC, Tsyrlin VA, Greenberg BH, Mayet J, Francis DP, Shaburishvili T, Monaghan M, Saltzberg M, Neyses L, Wasserman SM, Lee JH, Saikali KG, Clarke CP, Goldman JH, Wolff AA, Malik FI. The effects of the cardiac myosin activator, omecamtiv mecarbil, on cardiac function in systolic heart failure: a double-blind, placebo-controlled, crossover, dose-ranging phase 2 trial. Lancet. 2011 Aug 20;378(9792):676-83. doi: 10.1016/S0140-6736(11)61126-4.

Related trials for Heart Failure

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

17 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CK-1827452 in people with Heart Failure, run by Cytokinetics at 17 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United Kingdom, Russia, United States, Georgia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Aug 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline of Systolic Ejection Time at Various CK-1827452 Plasma Concentrations (time frame: 4 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00624442, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2021.