Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 4 of 18 for:    "Pure Autonomic Failure" | "Autonomic Agents"

Nitric Oxide and the Autonomic Nervous System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00178919
Recruitment Status : Completed
First Posted : September 15, 2005
Results First Posted : May 3, 2010
Last Update Posted : June 4, 2013
Sponsor:
Information provided by (Responsible Party):
Italo Biaggioni, Vanderbilt University

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor)
Conditions Hypertension
Pure Autonomic Failure
Interventions Drug: L-NMMA
Drug: Trimethaphan
Enrollment 112
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Autonomic Failure Patients Hypertensives and Controls
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 19 93
Completed 19 68
Not Completed 0 25
Arm/Group Title Autonomic Failure Patients Hypertensives and Controls Total
Hide Arm/Group Description To compare the effects of NO inhibition during intact and transient pharmacological blockade of the autonomic nervous system. To compare the effects of NO inhibition during intact and transient pharmacological blockade of the autonomic nervous system Total of all reporting groups
Overall Number of Baseline Participants 19 93 112
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 93 participants 112 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
13
  68.4%
93
 100.0%
106
  94.6%
>=65 years
6
  31.6%
0
   0.0%
6
   5.4%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 93 participants 112 participants
62  (10.4) 37  (11.8) 41  (14.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 93 participants 112 participants
Female
9
  47.4%
51
  54.8%
60
  53.6%
Male
10
  52.6%
42
  45.2%
52
  46.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 19 participants 93 participants 112 participants
19 93 112
1.Primary Outcome
Title Change in Systolic Blood Pressure
Hide Description 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.
Time Frame At the end of the highest tolerated dose of IV infusion of L-NMMA
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Autonomic Failure Patients Hypertensives and Controls
Hide Arm/Group Description:
To compare the effects of NO inhibition during intact and transient pharmacological blockade of the autonomic nervous system.
To compare the effects of NO inhibition during intact and transient pharmacological blockade of the autonomic nervous system
Overall Number of Participants Analyzed 19 68
Mean (Standard Error)
Unit of Measure: mm Hg
43  (6.2) 21  (8.4)
2.Primary Outcome
Title Systolic Blood Pressure in Response to Systemic Nitric Oxide Inhibition
Hide Description 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.
Time Frame End of 15 minutes of infusion of L-NMMA at the highest tolerated dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Autonomic Failure Patients Hypertensives and Controls
Hide Arm/Group Description:
To compare the effects of NO inhibition during intact and transient pharmacological blockade of the autonomic nervous system.
To compare the effects of NO inhibition during intact and transient pharmacological blockade of the autonomic nervous system
Overall Number of Participants Analyzed 19 68
Mean (Standard Deviation)
Unit of Measure: mm Hg
152  (6.8) 136  (13.8)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Autonomic Failure Patients Hypertensives and Controls
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Autonomic Failure Patients Hypertensives and Controls
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Autonomic Failure Patients Hypertensives and Controls
Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/93 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Autonomic Failure Patients Hypertensives and Controls
Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/93 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Italo Biaggioni
Organization: Vanderbilt University
Phone: 615-343-6499
EMail: italo.biaggioni@vanderbilt.edu
Layout table for additonal information
Responsible Party: Italo Biaggioni, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00178919     History of Changes
Other Study ID Numbers: 010876
NIH 1RO1HL71172
First Submitted: September 12, 2005
First Posted: September 15, 2005
Results First Submitted: April 10, 2009
Results First Posted: May 3, 2010
Last Update Posted: June 4, 2013