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Ganglionic Blocker
Trimethaphan for High Blood Pressure
Phase 1
Waitlist Available
Led By Italo Biaggioni, M.D.
Research Sponsored by Vanderbilt University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Neurogenic orthostatic hypotension defined as a ≥30-mmHg decrease in systolic blood pressure within 3 minutes of standing associated with impaired autonomic reflexes determined by autonomic testing in the absence of other identifiable causes
Male and female subjects, age 40-80 years, with possible or probable Multiple System Atrophy, as defined by Consensus Criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial is to study how the autonomic nervous system affects blood flow in the veins of the abdomen in people with high blood pressure.
Who is the study for?
This trial is for adults aged 40-80 with Multiple System Atrophy and specific blood pressure conditions: high blood pressure when lying down (≥150 mmHg) and a significant drop upon standing. Participants must be able to consent and have no recent major surgeries, severe reflux, implanted medical devices in the abdomen, or systemic illnesses like diabetes that affect nerves.Check my eligibility
What is being tested?
The study is testing Trimethaphan against a placebo to understand how the autonomic nervous system's control of abdominal veins affects blood pressure. It aims to involve about 16 eligible participants who will receive either the drug or placebo to see if there's an impact on their hypertension.See study design
What are the potential side effects?
While not explicitly listed, potential side effects of Trimethaphan may include headache, nausea, diarrhea, low blood pressure when standing up too quickly (orthostatic hypotension), and possible allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I experience a significant drop in blood pressure when standing, due to nerve issues.
Select...
I am between 40 and 80 years old and may have Multiple System Atrophy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The percentage of increase of the y intercept of the P-V relationship
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TrimethaphanExperimental Treatment1 Intervention
The investigator will measure cardiac output by studying the air the participant breathes in and out. The participant will also wear a facemask to apply a low air pressure to the airway.
After this, the trimethaphan infusion will begin with a small dose and the investigators increase at 1-2 minute intervals for up to five doses. The measurements will be collected again.
Next, a standard blood pressure cuffs will be wrapped around the participant's abdomen. the cuff will inflate to apply pressure for 5 - 15 minutes.
Group II: PlaceboPlacebo Group1 Intervention
The investigator will measure cardiac output by studying the air the participant breathes in and out. The participant will also wear a facemask to apply a low air pressure to the airway.
After this, the placebo (saline) infusion will begin with a small dose and the investigators increase at 1-2 minute intervals for up to five doses. The measurements will be collected again.
Next, a standard blood pressure cuffs will be wrapped around the participant's abdomen. the cuff will inflate to apply pressure for 5 - 15 minutes.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trimethaphan
FDA approved
Find a Location
Who is running the clinical trial?
Vanderbilt UniversityLead Sponsor
705 Previous Clinical Trials
6,143,421 Total Patients Enrolled
2 Trials studying Orthostatic Hypotension
397 Patients Enrolled for Orthostatic Hypotension
Italo Biaggioni, M.D.Principal InvestigatorVanderbilt University
6 Previous Clinical Trials
209 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe acid reflux.I have had recent fractures in my ribs or spine.I have no devices in my abdomen that would affect pressure application.I experience a significant drop in blood pressure when standing, due to nerve issues.I am between 40 and 80 years old and may have Multiple System Atrophy.I have a condition like diabetes that affects my nerves.I haven't had a major heart, brain event, or any condition that would stop me from completing the study in the last 6 months.I have a painful hernia in my abdomen or groin.I have not had surgery for aortic aneurysms or in my chest, abdomen, or pelvis in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Trimethaphan
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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