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Endothelin + L-Arginine for Vasoconstriction

Phase 1
Recruiting
Research Sponsored by The University of Texas at Arlington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights

Study Summary

This trial is looking at how well the body maintains blood flow to the skin during and after exposure to local heat, as well as during administration of drugs that narrow blood vessels.

Who is the study for?
This trial is for healthy adults aged 18-35 from the Arlington area, who identify as either African American or Caucasian American. Participants must not be on prescription meds, have a BMI over 30, smoke, or have donated significant blood recently. Women must have regular menstrual cycles and can't be pregnant or breastfeeding.Check my eligibility
What is being tested?
The study tests how different substances (BQ-788, BQ-123, L-Arginine and others) affect vasoconstriction in skin vessels during local heating. It aims to understand racial differences in microvascular function related to cardiovascular disease risks.See study design
What are the potential side effects?
While specific side effects are not listed here, the substances used may cause temporary changes in blood flow or pressure at the site of application. Since they're administered locally for testing vascular responses, systemic side effects are unlikely.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Vasodilatory Response to Endothelin Receptor-A/B Blockers and L-Arginine following local heating as assessed by Intradermal Microdialysis and Laser Doppler Fluxmetry

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: L-ArginineExperimental Treatment3 Interventions
This site will receive 10 mM L-Arginine to supplement the substrate for endothelial nitric oxide synthase. This site will additionally receive 20mM L-NAME and 28mM SNP to inhibit nitric oxide (NO) production and elicit vasodilation, respectively, to assess NO contribution and maximal vasodilation.
Group II: Inhibitor of Endothelin Type B ReceptorExperimental Treatment3 Interventions
This site will receive 300 nM BQ-788, an inhibitor of the endothelin type B receptors. This site will additionally receive 20mM L-NAME and 28mM SNP to inhibit nitric oxide (NO) production and elicit vasodilation, respectively, to assess NO contribution and maximal vasodilation.
Group III: Inhibition of Endothelin Type A ReceptorExperimental Treatment3 Interventions
This site will receive 500 nM aBQ-123, an inhibitor of endothelin type A receptors. This site will additionally receive 20mM L-NAME and 28mM SNP to inhibit nitric oxide (NO) production and elicit vasodilation, respectively, to assess NO contribution and maximal vasodilation.
Group IV: ControlActive Control3 Interventions
This site will serve as the control site and will receive lactated Ringer's (saline solution) (2 µl/min) throughout the entire duration of the protocol. This site will additionally receive 20mM L-NAME and 28mM SNP to inhibit nitric oxide (NO) production and elicit vasodilation, respectively, to assess NO contribution and maximal vasodilation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BQ-123
2010
Completed Phase 2
~170
L-Arginine
2018
Completed Phase 3
~290
NG Nitro L Arginine Methyl Ester
2018
Completed Phase 1
~20
Sodium Nitroprusside
2018
Completed Phase 1
~220

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

The University of Texas at ArlingtonLead Sponsor
43 Previous Clinical Trials
4,888 Total Patients Enrolled

Media Library

Local Heating (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03679780 — Phase 1
Cardiovascular Disease Research Study Groups: Control, Inhibitor of Endothelin Type B Receptor, Inhibition of Endothelin Type A Receptor, L-Arginine
Cardiovascular Disease Clinical Trial 2023: Local Heating Highlights & Side Effects. Trial Name: NCT03679780 — Phase 1
Local Heating (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03679780 — Phase 1

Frequently Asked Questions

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

Is geriatric participation being accepted in this clinical trial?

"Patients must be aged 18-35 to qualify for this trial. Meanwhile, 49 studies are available to participants below the age of majority and 512 trials catered towards seniors above 65 years old exist."

Answered by AI

For whom is enrollment into this clinical study available?

"For admittance in this trial, participants must be between 18-35 years old and display signs of vasoconstriction. The total number of patients accepted is 50."

Answered by AI

What precedent exists for the application of BQ-123 in clinical settings?

"Currently, BQ-123 is the subject of 126 active medical trials. Of these tests, 31 are in Phase 3 and most of them originate from Calgary, Alberta. However, its clinical trials can be found at 445 different sites worldwide."

Answered by AI

Is enrollment still open for this clinical trial?

"Affirmative. Information displayed on clinicaltrials.gov suggests that this research effort, which was first posted in October 2018 and revised in February 2022, is actively recruiting subjects for participation. Approximately 50 individuals are required from a single location."

Answered by AI

What is the total number of participants for this experiment?

"Correct. According to the information on clinicaltrials.gov, this trial is currently enrolling patients with an initial post date of October 1st 2018 and a last update from February 7th 2022. This medical study requires 50 participants across one location."

Answered by AI

Does this research break new ground in its field?

"BQ-123 has been a subject of medical research since 2007, when Baxter Healthcare Corporation first sponsored the initial clinical trial with 4640 participants. After the satisfactory results were published in early 2008, BQ-123 received its Phase 4 drug approval and is presently being studied at 126 sites across 187 cities and 37 countries."

Answered by AI

What conditions is BQ-123 employed to alleviate?

"BQ-123 is typically used in haemodiafiltration, yet it also has therapeutic potential for increasing intra ocular pressure (iop), alleviating nasal discomfort, and improving renal function."

Answered by AI

Has the FDA accepted BQ-123 for general use?

"Our team at Power gave BQ-123 a rating of 1 on the safety scale, as this is an early Phase 1 trial with limited evidence to support its efficacy and security."

Answered by AI

Who else is applying?

What site did they apply to?
Science and Engineering Research and Innovation Building
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
The Effect of Endothelin and L-Arginine on Racial Differences in Vasoconstriction
Matthew Brothers 2018. "The Effect of Endothelin and L-Arginine on Racial Differences in Vasoconstriction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03679780.
~5 spots leftby Dec 2024
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