Trial Outcomes & Findings for Nitric Oxide and the Autonomic Nervous System (NCT NCT00178919)

Results Overview

L-NMMA (nitric oxide synthase inhibitor) was infused intravenously at different doses for 15 minutes each, after blocking the autonomic nervous system with trimethaphan. The change in systolic blood pressure at the end of the highest tolerated dose is the main outcome. Trimethaphan infused intravenously was used to produce transient blockade of the autonomic nervous system to allow for a full response to nitric oxide inhibition (in the absence of the baroreflex.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

112 participants

Primary outcome timeframe

At the end of the highest tolerated dose of IV infusion of L-NMMA

Results posted on

2013-06-04

Participant Flow

Participant milestones

Participant milestones
Measure	Autonomic Failure Patients The NO synthase inhibitor L-NMMA was infused intravenously at different doses (125, 250 and 500 mcg/kg/min) until a systolic blood pressure of 150 mm Hg was reached.	Hypertensives and Controls The NO synthase inhibitor L-NMMA was infused intravenously at different doses (250, 500 mcg/kg/min) for 15 minutes each dose after acute transient pharmacological blockade of the autonomic nervous system with trimethaphan (4 mg/min) or with the autonomic nervous system intact.
Overall Study STARTED	19	93
Overall Study COMPLETED	19	68
Overall Study NOT COMPLETED	0	25

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Nitric Oxide and the Autonomic Nervous System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Autonomic Failure Patients n=19 Participants To compare the effects of NO inhibition during intact and transient pharmacological blockade of the autonomic nervous system.	Hypertensives and Controls n=93 Participants To compare the effects of NO inhibition during intact and transient pharmacological blockade of the autonomic nervous system	Total n=112 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants	93 Participants n=7 Participants	106 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	0 Participants n=7 Participants	6 Participants n=5 Participants
Age Continuous	62 years STANDARD_DEVIATION 10.4 • n=5 Participants	37 years STANDARD_DEVIATION 11.8 • n=7 Participants	41 years STANDARD_DEVIATION 14.8 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	51 Participants n=7 Participants	60 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	42 Participants n=7 Participants	52 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants	93 participants n=7 Participants	112 participants n=5 Participants

PRIMARY outcome

Timeframe: At the end of the highest tolerated dose of IV infusion of L-NMMA

L-NMMA (nitric oxide synthase inhibitor) was infused intravenously at different doses for 15 minutes each, after blocking the autonomic nervous system with trimethaphan. The change in systolic blood pressure at the end of the highest tolerated dose is the main outcome. Trimethaphan infused intravenously was used to produce transient blockade of the autonomic nervous system to allow for a full response to nitric oxide inhibition (in the absence of the baroreflex.

Outcome measures

Outcome measures
Measure	Autonomic Failure Patients n=19 Participants To compare the effects of NO inhibition during intact and transient pharmacological blockade of the autonomic nervous system.	Hypertensives and Controls n=68 Participants To compare the effects of NO inhibition during intact and transient pharmacological blockade of the autonomic nervous system
Change in Systolic Blood Pressure	43 mm Hg Standard Error 6.2	21 mm Hg Standard Error 8.4

PRIMARY outcome

Timeframe: End of 15 minutes of infusion of L-NMMA at the highest tolerated dose

Systolic blood pressure at the highest tolerated dose of IV infusion of L-NMMA during autonomic nervous system blockade with trimethaphan. Trimethaphan, infused intravenously was used to produce transient blockade of the autonomic nervous system to allow for a full response to nitric oxide inhibition (in the absence of the baroreflex.

Outcome measures

Outcome measures
Measure	Autonomic Failure Patients n=19 Participants To compare the effects of NO inhibition during intact and transient pharmacological blockade of the autonomic nervous system.	Hypertensives and Controls n=68 Participants To compare the effects of NO inhibition during intact and transient pharmacological blockade of the autonomic nervous system
Systolic Blood Pressure in Response to Systemic Nitric Oxide Inhibition	152 mm Hg Standard Deviation 6.8	136 mm Hg Standard Deviation 13.8

Adverse Events

Autonomic Failure Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Hypertensives and Controls

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

Italo Biaggioni

Vanderbilt University

Phone: 615-343-6499

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place