Nitric Oxide and the Autonomic Nervous System

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Italo Biaggioni, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00178919
First received: September 12, 2005
Last updated: May 24, 2013
Last verified: May 2013
Results First Received: April 10, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor)
Conditions: Hypertension
Pure Autonomic Failure
Interventions: Drug: L-NMMA
Drug: Trimethaphan

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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
  Hide Baseline Characteristics

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.
No text entered.

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  
Number of Participants  
[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
  Show All Outcome Measures

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


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
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
No text entered.  


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


No publications provided by Vanderbilt University

Publications automatically indexed to this study:

Responsible Party: Italo Biaggioni, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00178919     History of Changes
Other Study ID Numbers: 010876, NIH 1RO1HL71172
Study First Received: September 12, 2005
Results First Received: April 10, 2009
Last Updated: May 24, 2013
Health Authority: United States: Food and Drug Administration