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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 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.

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

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Vanderbilt UniversityLead Sponsor

703 Previous Clinical Trials

6,143,345 Total Patients Enrolled

9 Trials studying Multiple System Atrophy

353 Patients Enrolled for Multiple System Atrophy

Italo Biaggioni, M.D.Principal InvestigatorVanderbilt University

6 Previous Clinical Trials

209 Total Patients Enrolled

1 Trials studying Multiple System Atrophy

Media Library

Trimethaphan (Ganglionic Blocker) Clinical Trial Eligibility Overview. Trial Name: NCT02726711 — Phase 1

Multiple System Atrophy Research Study Groups: Trimethaphan, Placebo

Multiple System Atrophy Clinical Trial 2023: Trimethaphan Highlights & Side Effects. Trial Name: NCT02726711 — Phase 1

Trimethaphan (Ganglionic Blocker) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02726711 — Phase 1

Frequently Asked Questions

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

To what extent does Trimethaphan pose a threat to patients?

"Due to a lack of data regarding efficacy and safety, Trimethaphan has been assigned an initial score of 1 on our Power team's scale."

Answered by AI

Who qualifies for taking part in this medical experiment?

"This investigation is recruiting two volunteers with orthostatic hypotension whose age range falls between 40-80 years. Specifically, potential participants must be male or female and have either probable or possible Multiple System Atrophy as defined by the Consensus Criteria. Also, they must present Neurogenic Orthostatic Hypotension (≥30mmHg decrease of systolic blood pressure after standing up) confirmed through autonomic testing in addition to supine hypertension (systolic BP ≥150 mmHg on two occasions). Lastly, individuals should provide written informed consent prior to enrolling in this trial."

Answered by AI

Are individuals over the age of 50 being considered as participants in this scientific experiment?

"As per the study's parameters, interested participants must not be younger than 40 years old and can't exceed 80."

Answered by AI

Has Trimethaphan been explored in any prior experiments?

"Presently, two clinical trials are running in order to examine the efficacy of Trimethaphan. Although a majority of these studies take place in Nashville, Tennessee, there are also sites located elsewehere that have implemented this research protocol."

Answered by AI

What is the recruitment size for this experiment?

"This research is no longer actively searching for participants, as the trial was last updated on August 21st 2022. However, 1035 studies are currently recruiting individuals with orthostatic hypotension and 2 trials need patients to try Trimethaphan."

Answered by AI

Does this research effort currently have any open slots?

"This clinical trial has reached its enrollment capacity, as the last update was posted on August 21st 2022. For individuals seeking to participate in similar research, there are currently 1035 studies recruiting participants with orthostatic hypotension and two trials for Trimethaphan that remain open."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Reduction in Splanchnic Capacitance Contributes to Sympathetically Dependent Hypertension in Autonomic

Italo Biaggioni 2016. "Reduction in Splanchnic Capacitance Contributes to Sympathetically Dependent Hypertension in Autonomic". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02726711.

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