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Nitric Oxide and the Autonomic Nervous System

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00178919
First Posted: September 15, 2005
Last Update Posted: June 4, 2013
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.
Information provided by (Responsible Party):
Italo Biaggioni, Vanderbilt University
Results First Submitted: April 10, 2009  
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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Autonomic Failure Patients   Hypertensives and Controls
STARTED   19   93 
COMPLETED   19   68 
NOT COMPLETED   0   25 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Autonomic Failure Patients To compare the effects of NO inhibition during intact and transient pharmacological blockade of the autonomic nervous system.
Hypertensives and Controls To compare the effects of NO inhibition during intact and transient pharmacological blockade of the autonomic nervous system
Total Total of all reporting groups

Baseline Measures
   Autonomic Failure Patients   Hypertensives and Controls   Total 
Overall Participants Analyzed 
[Units: Participants]
 19   93   112 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   13   93   106 
>=65 years   6   0   6 
Age 
[Units: Years]
Mean (Standard Deviation)
 62  (10.4)   37  (11.8)   41  (14.8) 
Gender 
[Units: Participants]
     
Female   9   51   60 
Male   10   42   52 
Region of Enrollment 
[Units: Participants]
     
United States   19   93   112 


  Outcome Measures
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1.  Primary:   Change in Systolic Blood Pressure   [ Time Frame: At the end of the highest tolerated dose of IV infusion of L-NMMA ]

2.  Primary:   Systolic Blood Pressure in Response to Systemic Nitric Oxide Inhibition   [ Time Frame: End of 15 minutes of infusion of L-NMMA at the highest tolerated dose ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Italo Biaggioni
Organization: Vanderbilt University
phone: 615-343-6499
e-mail: italo.biaggioni@vanderbilt.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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