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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
Lean and obese, male and female subjects of all races between 18 and 65 years of age
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
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
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I am between 18 and 65 years old.
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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

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Vanderbilt UniversityLead Sponsor
702 Previous Clinical Trials
6,142,757 Total Patients Enrolled
Italo Biaggioni, MDPrincipal Investigator - Vanderbilt University
Vanderbilt University
28 Previous Clinical Trials
1,442 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who can participate in this medically-supervised research project?

"This clinical trial seeks to enrol 12 individuals affected by hypertension in the age range of 18-65. Eligible applicants must be comprised of a combination of genders, races and body types. In addition, candidates for this study must have blood pressure readings greater than or equal to 140/90 mm Hg taken from two different occasions while seated as well as demonstrate their ability and willingness to provide informed consent."

Answered by AI

What other scientific experiments have been conducted with Trimethaphan as a primary focus?

"Currently, seven clinical trials are being conducted with Trimethaphan. None of them have entered their final phase yet. Most tests for this treatment take place in New york City, but other US cities such as Miami and San Francisco also offer it."

Answered by AI

Is enrollment still underway for this investigation?

"According to clinicaltrials.gov, the recruitment process for this medical trial is ongoing. The study was initially uploaded on April 1st 2015 and recently updated August 21st 2022."

Answered by AI

Does this research embrace seniors as participants?

"This trial is open to anyone aged 18-65, with 55 clinical trials designated for those younger than the age of consent and an additional 666 studies available for participants over 65 years old."

Answered by AI

What maladies have been known to respond best to Trimethaphan?

"Trimethaphan is commonly used to manage myocardial infarction but can be employed for various other purposes such as treating anal fissure, angina attacks, and pain."

Answered by AI

How many individuals can participate in this experiment?

"Affirmative. Per the information published on clinicaltrials.gov, this medical trial is still recruiting participants and began doing so since April 1st 2015. The latest update was posted on August 21st 2022 and 12 patients are needed from one site only."

Answered by AI

Has Trimethaphan been recognized by the FDA as a viable form of treatment?

"Our team at Power assigned Trimethaphan a safety score of 1, as this is an early Phase 1 trial with limited evidence for both efficacy and security."

Answered by AI
~0 spots leftby Jul 2024