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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

Must not have

Severe gastroesophageal reflux

Recent fractures or fissures of ribs, thoracic or lumbar spine

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

All Individual Drugs Already Approved

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.

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.

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 below

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I experience a significant drop in blood pressure when standing, due to nerve issues.

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I am between 40 and 80 years old and may have Multiple System Atrophy.

Exclusion Criteria

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

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I have severe acid reflux.

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I have had recent fractures in my ribs or spine.

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I have no devices in my abdomen that would affect pressure application.

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I have a painful hernia in my abdomen or groin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

The percentage of increase of the y intercept of the P-V relationship

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.

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

0 / 6Eligibility criteria met