Autonomic Blockade for High Blood Pressure
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to explore how the body's nervous system might affect high blood pressure. Researchers are testing whether trimethaphan, a type of autonomic blockade, can help by blocking nerve signals that cause blood vessels to tighten. Participants will receive either trimethaphan or a comparison treatment with nitroglycerin to observe how these drugs influence blood pressure. Individuals with high blood pressure (systolic BP ≥140 mm Hg or diastolic BP ≥ 90 mm Hg) or normal blood pressure, who do not have chronic diseases like diabetes or heart disease, might be suitable for this study. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this treatment.
Will I have to stop taking my current medications?
The trial requires that participants do not take any medications that affect autonomic functions, so you may need to stop certain medications if they influence these functions.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have shown that nitroglycerin helps with heart-related issues like chest pain and high blood pressure by relaxing blood vessels, which can lower blood pressure. However, it may cause side effects such as headaches or low blood pressure if not monitored carefully. While generally well-tolerated, individuals with certain head injuries should avoid it due to its effects on blood flow.
Research shows that trimethaphan is used to quickly lower blood pressure in emergencies. It is effective but requires careful use in individuals with certain health conditions, like heart or liver disease. Some may experience a drop in blood pressure or dizziness. Trimethaphan has been studied for its ability to lower blood pressure without increasing blood flow to the brain, which can be beneficial in specific medical situations.
Overall, both treatments manage blood pressure, but like any medication, they can have side effects that require careful monitoring.12345Why are researchers excited about this trial's treatments?
Unlike the standard treatments for high blood pressure, like ACE inhibitors or beta-blockers, trimethaphan works by inducing autonomic blockade. This means it directly interrupts nerve signals that contribute to elevated blood pressure, offering a different mechanism of action compared to typical medications. Researchers are excited about trimethaphan because it is administered via continuous intravenous infusion, allowing for precise control over its effects. Additionally, its rapid action could offer quicker results in reducing blood pressure, which is particularly promising for managing acute situations.
What evidence suggests that this trial's treatments could be effective for high blood pressure?
Research has shown that trimethaphan, one of the treatments in this trial, effectively lowers blood pressure quickly. It blocks specific nerve signals that cause blood vessels to tighten. Studies indicate that it reduces blood pressure rapidly and consistently without causing it to drop too low, making it useful for managing high blood pressure during surgeries or emergencies. Trimethaphan has been used safely without causing serious side effects, such as a sudden increase in blood pressure or irregular heartbeats. Another treatment arm in this trial involves administering nitroglycerin sublingually to assess its effects on blood pressure.26789
Who Is on the Research Team?
Italo Biaggioni, MD
Principal Investigator
Vanderbilt University
Are You a Good Fit for This Trial?
This trial is for men and women aged 18-65 with high blood pressure, not on medication affecting autonomic functions, and without chronic diseases like diabetes or cardiovascular issues. Participants should be non-smokers, not pregnant, have a BMI under 40 kg/m2, and no strong family history of hypertension in lean normotensive subjects.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Baseline measurements of splanchnic capacitance and blood pressure are taken
Treatment
Participants undergo autonomic blockade with trimethaphan and receive nitroglycerin to assess changes in splanchnic capacitance
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Nitroglycerin
- Trimethaphan
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vanderbilt University
Lead Sponsor