N/A
N=112
Nitric Oxide and the Autonomic Nervous System
Hypertension · Pure Autonomic Failure
Bottom Line
View on ClinicalTrials.gov: NCT00178919 ↗Enrolled (actual)
112
Serious AEs
0.0%
Results posted
May 2010
Primary outcome: Primary: Change in Systolic Blood Pressure — 43; 21 mm Hg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- L-NMMA (Drug); Trimethaphan (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University
- Primary completion
- Aug 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Systolic Blood Pressure |
43; 21 | — |
| PRIMARY Systolic Blood Pressure in Response to Systemic Nitric Oxide Inhibition |
152; 136 | — |
Summary
The amount of blood flowing to the different parts of the body is regulated by the autonomic (automatic) nerves and by local factors produced by the blood vessels. Nitric oxide (NO) is one of the most important of these metabolic factors. If the production of NO is slowed or stopped the amount of blood to the different parts of the body is decreased. There is increasing knowledge that NO mechanisms are impaired in a number of medical conditions. NO function is reduced in patients with risk factors for atherosclerosis (hardening of the arteries) such as hypercholesterolemia (patients with high cholesterol), or diabetes mellitus, and is also impaired in smokers. This NO "deficiency" is believed to contribute to the greater cardiovascular risk that marks these patient populations. This study is designed to examine if endothelial nitric oxide is an important control mechanism of blood pressure under normal conditions, and if impairment of nitric oxide contributes to hypertension.
Eligibility Criteria
Inclusion Criteria
- Adult subjects.
- 18 to 85 years.
- Non-smokers or long term smokers for specific aim 6.
- Drug-free.
- Long term hypertension in specific substudy 3, patients with autonomic failure in specific aims 4 and 5, diabetes mellitus in specific aim 5.
Exclusion Criteria
- Being on any medication other than antihypertensives (for hypertensives), autonomic medications (for autonomic failure [AF] patients), insulin or other treatment for diabetes (for diabetic patients).
- Having pulmonary, renal, hematopoietic, hepatic and/or cardiac disease.
Data sourced from ClinicalTrials.gov (NCT00178919). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.