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Phase II Study of the Effect of CK-1827452 Injection on Myocardial Efficiency

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ClinicalTrials.gov Identifier: NCT00748579
Recruitment Status : Terminated (Decision to discontinue due to challenges of trial design and constraints on enrolling eligible and consenting patients.)
First Posted : September 8, 2008
Results First Posted : August 23, 2010
Last Update Posted : October 9, 2019
Sponsor:
Information provided by (Responsible Party):
Cytokinetics

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Heart Failure
Intervention Drug: CK-1827452
Enrollment 2
Recruitment Details The recruitment period was from September 2008 to July 2009.
Pre-assignment Details  
Arm/Group Title Mid Dose CK-1827452 (Cohort 1) High Dose CK-1827452 (Cohort 2)
Hide Arm/Group Description 0.5 hour loading infusion followed by 1.0 hour maintenance infusion of CK-1827452 ≤ 1.0 hour loading infusion followed by 1.0 hour maintenance infusion of CK-1827452
Period Title: Overall Study
Started 2 0
Completed 2 0
Not Completed 0 0
Arm/Group Title Mid Dose CK-1827452 (Cohort 1) High Dose CK-1827452 (Cohort 2) Total
Hide Arm/Group Description 0.5 hour loading infusion followed by 1.0 hour maintenance infusion of CK-1827452 ≤ 1.0 hour loading infusion followed by 1.0 hour maintenance infusion of CK-1827452 Total of all reporting groups
Overall Number of Baseline Participants 2 0 2
Hide Baseline Analysis Population Description
Study was terminated due to challenges of trial design and constraints on enrolling eligible and consenting patients
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 0 participants 2 participants
<=18 years
0
   0.0%
0
   0.0%
Between 18 and 65 years
1
  50.0%
1
  50.0%
>=65 years
1
  50.0%
1
  50.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2 participants 0 participants 2 participants
69  (13) 69  (13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 0 participants 2 participants
Female
2
 100.0%
2
 100.0%
Male
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants 0 participants 2 participants
2 2
1.Primary Outcome
Title Effect of CK-1827452 on Myocardial Efficiency, Defined as the Ratio of Ventricular Performance to Myocardial Oxygen Consumption.
Hide Description 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.
Time Frame 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
Study was terminated due to poor enrollment; 2 participants completed the study. Data quantity was insufficient to analyze or draw conclusions.
Arm/Group Title Mid Dose CK-1827452 (Cohort 1) High Dose CK-1827452 (Cohort 2)
Hide Arm/Group Description:
0.5 hour loading infusion followed by 1.0 hour maintenance infusion of CK-1827452
≤ 1.0 hour loading infusion followed by 1.0 hour maintenance infusion of CK-1827452
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Effects of CK-1827452 on Ventricular Performance, Myocardial Oxygen Consumption, Pressure-volume Relationships, Systolic Ejection Time and Invasively Measured Hemodynamics, Including Filling Pressures and Cardiac Output.
Hide Description Measure the effect of CK-1824752 on ventricular performance, myocardial oxygen consumption, pressure-volume relationships, systolic ejection time and invasively measured hemodynamics, including filling pressures and cardiac output
Time Frame 1 day
Hide Outcome Measure Data
Hide Analysis Population Description
No data displayed because Outcome Measure has zero total participants analyzed.
Arm/Group Title Mid Dose CK-1827452 (Cohort 1) High Dose CK-1827452 (Cohort 2)
Hide Arm/Group Description:
0.5 hour loading infusion followed by 1.0 hour maintenance infusion of CK-1827452
≤ 1.0 hour loading infusion followed by 1.0 hour maintenance infusion of CK-1827452
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 30 days
Adverse Event Reporting Description Two participants experienced 3 adverse events. There were no serious adverse events in this study.
 
Arm/Group Title Mid Dose CK-1827452 (Cohort 1) High Dose CK-1827452 (Cohort 2)
Hide Arm/Group Description 0.5 hour loading infusion followed by 1.0 hour maintenance infusion of CK-1827452 ≤ 1.0 hour loading infusion followed by 1.0 hour maintenance infusion of CK-1827452
All-Cause Mortality
Mid Dose CK-1827452 (Cohort 1) High Dose CK-1827452 (Cohort 2)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Mid Dose CK-1827452 (Cohort 1) High Dose CK-1827452 (Cohort 2)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/2 (0.00%)      0/0    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Mid Dose CK-1827452 (Cohort 1) High Dose CK-1827452 (Cohort 2)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/2 (100.00%)      0/0    
Cardiac disorders     
Supraventricular Tachycardia  1 [1]  1/2 (50.00%)  1 0/0  0
Investigations     
Troponin Increased  1 [2]  2/2 (100.00%)  2 0/0  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
[1]
The 1 supraventricular tachycardia was mild in intensity and resolved.
[2]
The 2 troponin increases were mild in intensity and resolved.
Inadequate enrollment led to early termination of study and insufficient number of patients for analysis.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Sponsor's intention was to publish the results of the trial in collaboration with the Investigators.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Cytokinetics, Inc.
Phone: (650) 624-3011
Layout table for additonal information
Responsible Party: Cytokinetics
ClinicalTrials.gov Identifier: NCT00748579     History of Changes
Other Study ID Numbers: CY 1124
First Submitted: April 21, 2008
First Posted: September 8, 2008
Results First Submitted: July 30, 2010
Results First Posted: August 23, 2010
Last Update Posted: October 9, 2019