Trial Outcomes & Findings for The Acute Effects of the Angiotensin-converting Enzyme Inhibitor Enalaprilat on Flow Distribution (NCT NCT00741156)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

12 participants

Primary outcome timeframe

Baseline and after enalaprilat

Results posted on

2015-12-18

Participant milestones
Measure	Enalaprilat Enalaprilat : Enalaprilat will be administered intravenously i.v. 0.01 mg/kg i.v. over 1 minute
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Withdrawal data not reported

The Acute Effects of the Angiotensin-converting Enzyme Inhibitor Enalaprilat on Flow Distribution

Baseline characteristics by cohort
Measure	Enalaprilat n=12 Participants Enalaprilat : Enalaprilat will be administered intravenously i.v. 0.01 mg/kg i.v. over 1 minute
Age, Categorical <=18 years	12 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age, Continuous	2.3 years STANDARD_DEVIATION 1 • n=93 Participants
Sex: Female, Male Female	NA Participants n=93 Participants
Sex: Female, Male Male	NA Participants n=93 Participants
Region of Enrollment Canada	12 participants n=93 Participants

Timeframe: Baseline and after enalaprilat

Outcome measures
Measure	Systemic Blood Flow Baseline n=12 Participants Systemic blood flow in baseline condition	Systemic Blood Flow After Enalaprilat n=12 Participants Systemic blood flow 20 minutes after enalaprilat	Pulmonary Blood Flow Baseline n=12 Participants Pulmonary blood flow baseline condition	Pulmonary Blood Flow After Enaliprilat n=12 Participants Pulmonary blood flow 20 minutes after enalaprilat	Cerebral Blood Flow Baseline n=12 Participants Cerebral blood flow at baseline	Cerebral Blood Flow After Enalaprilat n=12 Participants Cerebral blood flow 20 minutes after enalaprilat
Systemic, Pulmonary and Cerebral Blood Flow at Baseline and After Enalaprilat	1.4 l/min/m2 Interval 0.9 to 1.8	1.8 l/min/m2 Interval 1.0 to 2.2	1.9 l/min/m2 Interval 1.8 to 2.9	1.9 l/min/m2 Interval 1.6 to 2.5	1.9 l/min/m2 Interval 1.6 to 2.9	1.8 l/min/m2 Interval 1.6 to 2.5

Timeframe: Baseline and after enalaprilat

Systemic, pulmonary and cerebral resistance is compared at baseline and after enalaprilat

Outcome measures
Measure	Systemic Blood Flow Baseline n=12 Participants Systemic blood flow in baseline condition	Systemic Blood Flow After Enalaprilat n=12 Participants Systemic blood flow 20 minutes after enalaprilat	Pulmonary Blood Flow Baseline n=12 Participants Pulmonary blood flow baseline condition	Pulmonary Blood Flow After Enaliprilat n=12 Participants Pulmonary blood flow 20 minutes after enalaprilat	Cerebral Blood Flow Baseline n=12 Participants Cerebral blood flow at baseline	Cerebral Blood Flow After Enalaprilat n=12 Participants Cerebral blood flow 20 minutes after enalaprilat
Systemic, Pulmonary and Cerebral Resistance at Baseline and After Enalaprilat	40.94 Wood units per metre squared Interval 26.63 to 67.83	20.26 Wood units per metre squared Interval 16.5 to 28.16	2.87 Wood units per metre squared Interval 1.03 to 4.47	2.54 Wood units per metre squared Interval 0.49 to 4.76	24.07 Wood units per metre squared Interval 15.79 to 38.1	17.32 Wood units per metre squared Interval 13.57 to 21.79

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

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