Trial · NCT00624442
A Study of CK-1827452 Infusion in Stable Heart Failure
NCT00624442, Phase 2, Completed, Cytokinetics; results first posted 2010-08-16
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. A Study of CK-1827452 Infusion in Stable Heart Failure. Trials, record NCT00624442. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00624442
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of CK-1827452 Infusion in Stable Heart Failure
- NCT number
- NCT00624442
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 45 participants, actual
- Lead sponsor
- Cytokinetics
- Conditions
- Heart Failure
- Interventions
- CK-1827452, CK-1827452, CK-1827452, CK-1827452, CK-1827452, CK-1827452, CK-1827452, CK-1827452, Placebo, Placebo, CK-1827452, Placebo, CK-1827452, CK-1827452, CK-1827452, CK-1827452
- First posted
- 2008-02-27
- Last updated
- 2021-05-14
- Results first posted
- 2010-08-16
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline of Systolic Ejection Time at Various CK-1827452 Plasma Concentrations | 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. |
| Primary | Change From Baseline of Fractional Shortening at Various CK-1827452 Plasma Concentrations | 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. |
| Secondary | CK-1827452 Maximum Observed Plasma Concentration (Cmax) | 2 days | 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 |
| Secondary | CK-1827452 Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Plasma Concentration (AUClast) | 2 days | 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 |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline of Systolic Ejection Time at Various CK-1827452 Plasma Concentrations | 4 days | 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. | msec | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline of Fractional Shortening at Various CK-1827452 Plasma Concentrations | 4 days | 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. | Percentage of change | LEAST_SQUARES_MEAN |
| SECONDARY | CK-1827452 Maximum Observed Plasma Concentration (Cmax) | 2 days | nanogram/milliliter | MEAN | |
| SECONDARY | CK-1827452 Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Plasma Concentration (AUClast) | 2 days | hour x nanogram/milliliter | MEAN |
Source ClinicalTrials.gov
Results by group50
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline of Systolic Ejection Time at Various CK-1827452 Plasma Concentrations | >0-100 ng/mL | # of Echocardiographic Observations (no units) | 84 | Standard Error 0 | msec |
| Change From Baseline of Systolic Ejection Time at Various CK-1827452 Plasma Concentrations | >100-200 ng/mL | # of Echocardiographic Observations (no units) | 62 | Standard Error 0 | msec |
| Change From Baseline of Systolic Ejection Time at Various CK-1827452 Plasma Concentrations | >200-300 ng/mL | # of Echocardiographic Observations (no units) | 42 | Standard Error 0 | msec |
| Change From Baseline of Systolic Ejection Time at Various CK-1827452 Plasma Concentrations | >300-400 ng/mL | # of Echocardiographic Observations (no units) | 24 | Standard Error 0 | msec |
| Change From Baseline of Systolic Ejection Time at Various CK-1827452 Plasma Concentrations | >400-500 ng/mL | # of Echocardiographic Observations (no units) | 20 | Standard Error 0 | msec |
| Change From Baseline of Systolic Ejection Time at Various CK-1827452 Plasma Concentrations | >500 ng/mL | # of Echocardiographic Observations (no units) | 46 | Standard Error 0 | msec |
| Change From Baseline of Systolic Ejection Time at Various CK-1827452 Plasma Concentrations | >0-100 ng/mL | Ejection Fraction msec Change from Baseline | 1 | Standard Error 4 | msec |
| Change From Baseline of Systolic Ejection Time at Various CK-1827452 Plasma Concentrations | >100-200 ng/mL | Ejection Fraction msec Change from Baseline | 18 | Standard Error 4 | msec |
| Change From Baseline of Systolic Ejection Time at Various CK-1827452 Plasma Concentrations | >200-300 ng/mL | Ejection Fraction msec Change from Baseline | 47 | Standard Error 5 | msec |
| Change From Baseline of Systolic Ejection Time at Various CK-1827452 Plasma Concentrations | >300-400 ng/mL | Ejection Fraction msec Change from Baseline | 58 | Standard Error 6 | msec |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1 | 8 | |
| Overall Study | STARTED | Cohort 2 | 9 | |
| Overall Study | STARTED | Cohort 3 | 10 | |
| Overall Study | STARTED | Cohort 4 | 8 | |
| Overall Study | STARTED | Cohort 5 | 10 | |
| Overall Study | COMPLETED | Cohort 1 | 8 | |
| Overall Study | COMPLETED | Cohort 2 | 8 | |
| Overall Study | COMPLETED | Cohort 3 | 8 | |
| Overall Study | COMPLETED | Cohort 4 | 8 | |
| Overall Study | COMPLETED | Cohort 5 | 8 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events180
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Orthostatic hypotension | Vascular disorders | Placebo | 2 | 41 | 2 |
| other | Orthostatic hypotension | Vascular disorders | Cohorts 1 and/or 2, Loading Dose of 0.125 mg/kg/hr | 0 | 8 | 0 |
| other | Orthostatic hypotension | Vascular disorders | Cohorts 1 and/or 2, Loading Dose of 0.25 mg/kg/hr | 0 | 9 | 0 |
| other | Orthostatic hypotension | Vascular disorders | Cohorts 1 and/or 2, Loading Dose of 0.5 mg/kg/hr | 0 | 16 | 0 |
| other | Orthostatic hypotension | Vascular disorders | Cohorts 1 and/or 2, Loading Dose of 1.0 mg/kg/hr | 1 | 6 | 1 |
| other | Orthostatic hypotension | Vascular disorders | Cohorts 1 and/or 2, Loading Dose of 0.75 mg/kg/hr | 0 | 8 | 0 |
| other | Orthostatic hypotension | Vascular disorders | Cohort 2, Loading Dose of 2.2 mg/kg/hr | 0 | 1 | 0 |
| other | Orthostatic hypotension | Vascular disorders | Cohorts 3 and 4, Loading Dose of 0.25 mg/kg/hr | 1 | 18 | 1 |
| other | Orthostatic hypotension | Vascular disorders | Cohorts 3 and 4, Loading Dose of 0.5 mg/kg/hr | 1 | 18 | 1 |
| other | Orthostatic hypotension | Vascular disorders | Cohorts 3 and 4, Loading Dose of 1.0 mg/kg/hr | 0 | 16 | 0 |
1 to 10 of 180Source ClinicalTrials.gov
See all 180 adverse eventsAdverse event totals36
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Cohorts 1 and/or 2, Loading Dose of 0.125 mg/kg/hr | ||
| Total, all-cause mortality | Cohorts 1 and/or 2, Loading Dose of 0.25 mg/kg/hr | ||
| Total, all-cause mortality | Cohorts 1 and/or 2, Loading Dose of 0.5 mg/kg/hr | ||
| Total, all-cause mortality | Cohorts 1 and/or 2, Loading Dose of 1.0 mg/kg/hr | ||
| Total, all-cause mortality | Cohorts 1 and/or 2, Loading Dose of 0.75 mg/kg/hr | ||
| Total, all-cause mortality | Cohort 2, Loading Dose of 2.2 mg/kg/hr | ||
| Total, all-cause mortality | Cohorts 3 and 4, Loading Dose of 0.25 mg/kg/hr | ||
| Total, all-cause mortality | Cohorts 3 and 4, Loading Dose of 0.5 mg/kg/hr | ||
| Total, all-cause mortality | Cohorts 3 and 4, Loading Dose of 1.0 mg/kg/hr |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00624442
GET https://conductscience.org/api/trials/v1/NCT00624442/results?page=2