Heart FailurePhase 2NCT00748579
Phase II Study of the Effect of CK-1827452 Injection on Myocardial Efficiency
A Phase 2 study testing CK-1827452 in people with Heart Failure, run by Cytokinetics at 3 sites in 2 countries.
Trial 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… 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?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Sep 2008to Jul 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
- 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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Johns Hopkins Medical Institutions
Baltimore, Maryland, 21205
UUHSC / Division of Cardiology
Salt Lake City, Utah, 84132
About this study
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
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.
- Conditions
- Heart Failure
- Being tested
- CK-1827452
- 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
I.V. infusion for 0.5 hour at 54mg/hr followed by 1 hour at 21mg/hr
CK-1827452Drug
I.V. infusion for ≤ 1 hour at 72mg/hr followed by 1 hour at 36mg/hr
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 0.5 hour loading dose followed by 1.0 hour maintenance dose of CK-1827452 Receives: Drug: CK-1827452 |
| Cohort 2 | Experimental | ≤ 1.0 hour loading dose followed by 1.0 hour maintenance dose of CK-1827452 Receives: Drug: CK-1827452 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of CK-1827452 on Myocardial Efficiency, Defined as the Ratio of Ventricular Performance to Myocardial Oxygen Consumption.
Measure the effect CK-1827452 on hemodynamics and energetic measures of ventricular performance, myocardial oxygen consumption, and myocardial efficiency (the ratio of ventricular performance to myocardial oxygen consumption), in patients with clinical heart failure.
Measured: 1 day
Secondary outcomes (5)
Effects of CK-1827452 on Ventricular Performance
Measure the effect of CK-1824752 on ventricular performance
Measured: 1 day
Effects of CK-1827452 on Myocardial Oxygen Consumption
Measure the effect of CK-1824752 on myocardial oxygen consumption
Measured: 1 day
Effects of CK-1827452 on Pressure-volume Relationships
Measure the effect of CK-1824752 on pressure-volume relationships
Measured: 1 day
Effects of CK-1827452 on Systolic Ejection Time
Measure the effect of CK-1824752 on systolic ejection time
Measured: 1 day
Effects of CK-1827452 on Invasively Measured Hemodynamics, Including Filling Pressure and Cardiac Output
Measure the effect of CK-1824752 on invasively measured hemodynamics, including filling pressure and cardiac output
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionNov 2008
- Study completionJul 2009
Why it stopped: Decision to discontinue due to challenges of trial design and constraints on enrolling eligible and consenting patients.
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.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cytokinetics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00748579
- Sponsor's protocol ID
- CY 1124
- Status last verified
- Jan 2020
- First submitted
- 21 Apr 2008
- Last updated
- 21 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00748579
- Acronym / sponsor ID
- CY 1124
- Conditions
- Heart Failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Decision to discontinue due to challenges of trial design and constraints on enrolling eligible and consenting patients.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- CytokineticsIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 8 Sep 2008 (estimated)
- Results
- Posted 23 Aug 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: CK-18274520.5 hour loading dose followed by 1.0 hour maintenance dose of CK-1827452 |
| Cohort 2 | Experimental | Drug: CK-1827452≤ 1.0 hour loading dose followed by 1.0 hour maintenance dose of CK-1827452 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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%
Key exclusion criteria (15 listed)
- Acute myocarditis
- Hypertrophic, restrictive, or constrictive cardiomyopathy
- Congenital heart disease
- Known left ventricular thrombus
- Significant stenotic valvular disease (severe aortic stenosis, mitral stenosis)
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-1827452I.V. infusion for 0.5 hour at 54mg/hr followed by 1 hour at 21mg/hr | Drug | Cohort 1 |
| CK-1827452I.V. infusion for ≤ 1 hour at 72mg/hr followed by 1 hour at 36mg/hr | Drug | Cohort 2 |
Primary outcome
Effect of CK-1827452 on Myocardial Efficiency, Defined as the Ratio of Ventricular Performance to Myocardial Oxygen Consumption.
Time frame: 1 day
Measure the effect CK-1827452 on hemodynamics and energetic measures of ventricular performance, myocardial oxygen consumption, and myocardial efficiency (the ratio of ventricular performance to myocardial oxygen consumption), in patients with clinical heart failure.
5 secondary outcomes
Effects of CK-1827452 on Ventricular Performance
Time frame: 1 day
Effects of CK-1827452 on Myocardial Oxygen Consumption
Time frame: 1 day
Effects of CK-1827452 on Pressure-volume Relationships
Time frame: 1 day
Effects of CK-1827452 on Systolic Ejection Time
Time frame: 1 day
Effects of CK-1827452 on Invasively Measured Hemodynamics, Including Filling Pressure and Cardiac Output
Time frame: 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
3 sites in 2 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 3 sites in 2 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 9 inclusion and 15 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: stopped early, as of the sponsor's last update on 21 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Canada. 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 23 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?
Effect of CK-1827452 on Myocardial Efficiency, Defined as the Ratio of Ventricular Performance to Myocardial Oxygen Consumption. (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jan 2020.