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Adrenergic Receptor Modulators for Vascular Function (STARS Trial)
Phase 4
Recruiting
Led By Craig Steinback, PhD
Research Sponsored by University of Alberta
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 10 minutes per condition + 2 minutes per agonist dose = 60 minutes
Awards & highlights
STARS Trial Summary
This trial studies how sex hormones and the sympathetic nervous system impact blood pressure in males and females. Medications and tests will be used to measure activity in the forearm.
Who is the study for?
Healthy males and females aged 18-40, with no history of major diseases, can join this study. Females must be pre-menopausal and not pregnant or breastfeeding. Participants should avoid caffeine, alcohol, strenuous exercise, and certain medications for at least 12 hours before the visit.Check my eligibility
What is being tested?
The trial tests how the 'fight or flight' response differs between sexes by using small doses of blood pressure medications in one arm and measuring changes in blood flow. It involves a single visit lasting about 3 hours to assess these responses through various methods including a blood test.See study design
What are the potential side effects?
Possible side effects from the medications used may include temporary local reactions like redness or swelling where injected, increased heart rate, headache, dizziness or nausea due to changes in blood pressure.
STARS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 minutes per condition + 2 minutes per agonist dose = 60 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 minutes per condition + 2 minutes per agonist dose = 60 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Arterial blood pressure
Circulating sex hormone concentrations
Circulating sympathetic neurotransmitter concentrations
+4 moreSecondary outcome measures
Arterial-venous blood gas concentrations
STARS Trial Design
3Treatment groups
Experimental Treatment
Group I: β-Adrenergic BlockadeExperimental Treatment2 Interventions
β-adrenoreceptors will be blocked locally in the forearm using propranolol. Normal saline will be co-infused at the calculated rate of phentolamine in the α+β-blockade condition to control for volumetric effects.
Group II: α+β-Adrenergic BlockadeExperimental Treatment4 Interventions
α-adrenoreceptors will be blocked locally in the forearm using phentolamine. Propranolol will be co-infused to maintain β-blockade.
Group III: Control ConditionExperimental Treatment3 Interventions
Normal saline will be infused through the brachial artery catheter at the same calculated rate as propranolol + phentolamine in the α+β-blockade condition to control for volumetric effects.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Propranolol Hydrochloride
2021
Completed Phase 3
~130
Phenylephrine Hydrochloride
2019
N/A
~50
Phentolamine Mesylate
2022
N/A
~20
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Who is running the clinical trial?
University of AlbertaLead Sponsor
889 Previous Clinical Trials
385,147 Total Patients Enrolled
3 Trials studying Vasoconstriction
50 Patients Enrolled for Vasoconstriction
Craig Steinback, PhDPrincipal InvestigatorUniversity of Alberta
3 Previous Clinical Trials
83 Total Patients Enrolled
2 Trials studying Vasoconstriction
33 Patients Enrolled for Vasoconstriction
Sean van Diepen, MD, MScPrincipal InvestigatorUniversity of Alberta
3 Previous Clinical Trials
50 Total Patients Enrolled
3 Trials studying Vasoconstriction
50 Patients Enrolled for Vasoconstriction
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't used a beta-agonist inhaler like Ventolin in the last 24 hours.I am a woman who gave birth or have been breastfeeding within the last year.I have no history of heart, lung, nerve, or metabolic diseases.I am not on MAO inhibitors or tricyclic antidepressants.I am not pregnant, as confirmed by a test.I have gone through menopause.I have a health condition that could affect my blood pressure.I have a bleeding or clotting disorder, or I am on blood thinners.I am a woman and have not gone through menopause.I am not allergic to sulfites or any components in the study drugs.I am between 18 and 40 years old.I am classified as obese based on my BMI.I haven't had caffeine, alcohol, done heavy exercise, or taken irregular meds in the last 12 hours.I have smoked regularly in the past 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: β-Adrenergic Blockade
- Group 2: α+β-Adrenergic Blockade
- Group 3: Control Condition
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the Control Condition received authorization from the Food & Drug Administration?
"There is a substantial body of evidence backing the safety profile of Control Condition, leading to it receiving an overall score of 3."
Answered by AI
Does this research involve individuals aged 30 and above?
"The minimum age of entry for this trial is 18 years old, while the maximum allowable age is 40."
Answered by AI
What are the criteria for participants to join this clinical experiment?
"Candidates with vasoconstriction falling within the age range of 18 and 40 years old can be accepted to this clinical trial. A total of 30 patients are being admitted as part of this study."
Answered by AI
Is this experiment in progress and open to new participants?
"The clinical trial database hosted on clinicialtrials.gov states that this medical study, which was initially posted in the 1st of September 2023, is no longer seeking participants. However, there are 15 other trials actively searching for volunteers at this time."
Answered by AI
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