At a glance
ClinicalIndex Comparison Record- ✓Age 18 to 85 years
- ✓Adult subjects
- ✓Drug-free status
- ✓Long-term hypertension (for substudy 3) or autonomic failure (for aims 4-5) or diabetes mellitus (for aim 5)
- ✕Current use of medications other than antihypertensives (for hypertensive subjects), autonomic medications (for autonomic failure patients), or insulin/diabetes treatments (for diabetic subjects)
- ✕Pulmonary, renal, hematopoietic, hepatic, and/or cardiac disease
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Cardiovascular Regulation: Autonomic/Metabolic Mechanisms PO1 HL56693, Project 4: Cardiovascular Regulation: Autonomic/Metabolic Mechanisms
In Brief
A clinical study evaluating L-NMMA and Trimethaphan for Hypertension and Pure Autonomic Failure. Completed, enrolled 112 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
IV infusion of 125, 250 and 500 mcg/Kg/min for 15 minutes each dose. The main outcome is the maximal increase in blood pressure produced at the end of the infusions or a maximal systolic blood pressure of 160 mm Hg. It could be achieved after the first dose or the third.
IV infusion for the duration of the study at 4-6 mg/min depending on autonomic blockade. This is only to produce transient pharmacological blockade of the autonomic nervous system in order to allow the full expression of the inhibition of nitric oxide synthase. There is no direct outcome associated with this intervention.