Trial Outcomes & Findings for Myocardial Hemodynamic Effects of Levosimendan (NCT NCT00585104)

NCT ID: NCT00585104

Last Updated: 2013-05-21

Results Overview

Left ventricular end-diastolic pressure (LVEDP) recorded from CD Leycom ConductNT software analysis.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

From baseline to 30-minutes after levosimendan started.

Results posted on

2013-05-21

Participant Flow

Participant milestones

Participant milestones
Measure	Levosimendan, Compare Heart Function and Metabolism All patients received Levosimendan (12mcg/kg IV bolus over 10 minutes, Abbott Laboratories, Abbott Park, IL). All study measurements occur at baseline and 30-minutes after the initiation of levosimendan.
Overall Study STARTED	10
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Myocardial Hemodynamic Effects of Levosimendan

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Levosimendan, Compare Heart Function and Metabolism n=10 Participants All patients received Levosimendan (12mcg/kg IV bolus over 10 minutes, Abbott Laboratories, Abbott Park, IL). All study measurements occur at baseline and 30-minutes after the initiation of levosimendan.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	59 years STANDARD_DEVIATION 13.6 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants
Left Ventricular End Diastolic Pressure (LVEDP)	18 mmHg STANDARD_DEVIATION 7 • n=5 Participants

PRIMARY outcome

Timeframe: From baseline to 30-minutes after levosimendan started.

Population: Ten patients were enrolled. Complete data was available in 6 patients. The primary endpoint was change in left ventricular end diastolic pressure (LVEDP) from baseline to 30-minutes after starting levosimendan. An Intent to Treat (ITT) analysis was performed.

Left ventricular end-diastolic pressure (LVEDP) recorded from CD Leycom ConductNT software analysis.

Outcome measures

Outcome measures
Measure	Levosimendan, Compare Heart Function and Metabolism n=6 Participants All patients received Levosimendan (12mcg/kg IV bolus over 10 minutes, Abbott Laboratories, Abbott Park, IL). All study measurements occur at baseline and 30-minutes after the initiation of levosimendan.
Change in Left Ventricular End-diastolic Pressure (LVEDP) Using Pressure-volume Catheter.	5.67 mmHg Standard Deviation 4.32

Adverse Events

Levosimendan, Compare Heart Function and Metabolism

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Andrew D. Michaels, MD

University of Utah Health Sciences Center

Phone: (801) 585-5971

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place