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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

Must not have

Subjects with morbid obesity (BMI > 40 kg/m2)

Current smokers or history of heavy smoking (>2 packs/day)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after 10 minutes of autonomic blockade

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

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.

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.

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

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I have normal blood pressure or controlled high blood pressure.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My BMI is over 40.

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I am a current smoker or have a history of heavy smoking.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ after 10 minutes of autonomic blockade

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Splanchnic venous capacitance

Secondary study objectives

Stroke volume

Systolic Blood Pressure

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 3Eligibility criteria met