Trial Outcomes & Findings for Phase II Study of the Effect of CK-1827452 Injection on Myocardial Efficiency (NCT NCT00748579)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

1 day

Results posted on

2020-01-21

Participant Flow

The recruitment period was from September 2008 to July 2009.

Participant milestones

Participant milestones
Measure	Mid Dose CK-1827452 (Cohort 1) 0.5 hour loading infusion followed by 1.0 hour maintenance infusion of CK-1827452	High Dose CK-1827452 (Cohort 2) ≤ 1.0 hour loading infusion followed by 1.0 hour maintenance infusion of CK-1827452
Overall Study STARTED	2	0
Overall Study COMPLETED	2	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mid Dose CK-1827452 (Cohort 1) n=2 Participants 0.5 hour loading infusion followed by 1.0 hour maintenance infusion of CK-1827452	High Dose CK-1827452 (Cohort 2) ≤ 1.0 hour loading infusion followed by 1.0 hour maintenance infusion of CK-1827452	Total n=2 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	—	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=93 Participants	—	1 Participants n=27 Participants
Age, Categorical >=65 years	1 Participants n=93 Participants	—	1 Participants n=27 Participants
Age, Continuous	69 years STANDARD_DEVIATION 13 • n=93 Participants	—	69 years STANDARD_DEVIATION 13 • n=27 Participants
Sex: Female, Male Female	2 Participants n=93 Participants	—	2 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	—	0 Participants n=27 Participants
Region of Enrollment United States	2 participants n=93 Participants	—	2 participants n=27 Participants

PRIMARY outcome

Timeframe: 1 day

Population: Study was terminated due to poor enrollment; 2 participants completed the study. Data quantity was insufficient to analyze or draw conclusions.

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.