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Autonomic Nervous System Blocker

Autonomic Blockade for High Blood Pressure

Phase 1
Waitlist Available
Led By Italo Biaggioni, MD
Research Sponsored by Vanderbilt University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Normotensive and hypertensive subjects will be enrolled. Hypertension will be defined as a systolic BP ≥140 mm Hg and/or a diastolic BP ≥ 90 mm Hg, taken in the seated position in at least 2 separate occasions. All subjects will be otherwise normal volunteers
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after 10 minutes of autonomic blockade
Awards & highlights

Study Summary

This trial will study whether abdominal veins play a role in human hypertension, by testing subjects' blood pressure with and without autonomic nervous system blockade.

Who is the study for?
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.Check my eligibility
What is being tested?
The study aims to understand the role of abdominal veins (splanchnic capacitance) and sympathetic nervous system activity in hypertension by using Trimethaphan and Nitroglycerin to block autonomic nervous system signals temporarily.See study design
What are the potential side effects?
Potential side effects may include dizziness or lightheadedness due to changes in blood pressure from Trimethaphan or Nitroglycerin. There might also be headaches or flushing as common reactions to these medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have normal blood pressure or controlled high blood pressure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after 10 minutes of autonomic blockade
This trial's timeline: 3 weeks for screening, Varies for treatment, and after 10 minutes of autonomic blockade for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Splanchnic venous capacitance
Secondary outcome measures
Stroke volume
Systolic Blood Pressure

Trial Design

2Treatment groups
Experimental Treatment
Group I: Study day with trimethaphanExperimental Treatment1 Intervention
After baseline measurements, autonomic blockade will be induced by continuous intravenous infusion of trimethaphan starting at 0.5-1.0 mg/min and increasing by 1.0 mg/min every 2 to 6 minutes up to an infusion rate of 5 mg/min.
Group II: Radionuclide Study day with nitroglycerinExperimental Treatment1 Intervention
Sublingual nitroglycerin (0.3-0.6 mg) will be given after baseline measurements. Outcome measurements will be repeated within 10 min after the nitroglycerin has dissolved
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trimethaphan
FDA approved
Nitroglycerin
FDA approved

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Vanderbilt UniversityLead Sponsor
705 Previous Clinical Trials
6,143,411 Total Patients Enrolled
Italo Biaggioni, MDPrincipal Investigator - Vanderbilt University
Vanderbilt University
28 Previous Clinical Trials
1,442 Total Patients Enrolled
~0 spots leftby Jul 2024
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