HypertensionEnd-StressNCT02116335
Endothelin Receptor Function and Acute Stress
A study testing Bosentan in people with Hypertension, run by Augusta University at 1 site in United States.
Trial summary
Our bodies respond differently to stress. Animal studies by the investigators have found that endothelin-1 plays a role in regulating blood pressure in response to stress. This study is an extension of the investigators previous animal work to evaluate the role of endothelin-1 during stress in humans. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Bosentan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 320 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and premenopausal women (Ages 18-50 years old)
- Self-reported Black and White adults
- Lean adults (BMl <25 kg/m^)
- Obese adults (BMl > 30 kg/m^)
Who cannot join
- Having a BMI less than 16 kg/m2 (severely and very severely underweight) or that is greater than 40 kg/m2 (Class III obesity)
- Having evidence of cardiovascular, pulmonary, renal, hepatic, cerebral, or metabolic disease
- Having evidence of pregnancy
- Using medications that affect vascular tone (i.e., nitrates, etc.)
- Postmenopausal women
- Uncontrolled hypertension
Show all 11Show fewer
- Individuals who are on a restricted salt diet
- Having a history of chronic pain
- Having a history of rheumatoid arthritis
- Using medications that are contraindicated with bosentan (i.e. glyburide, cyclosporine)
- Liver dysfunction (which may be identified with the blood sample we take)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endothelin Receptor Function and Acute Stress (End-Stress)
Our bodies respond differently to stress. Animal studies by the investigators have found that endothelin-1 plays a role in regulating blood pressure in response to stress. This study is an extension of the investigators previous animal work to evaluate the role of endothelin-1 during stress in humans.
Read the detailed description
Using a salt sensitive animal model of prehypertension, the Dahl S rat,the investigators have previously published that acute stress elicits a pressor response that is accompanied by an increase in 8 isoprostane and endothelin-1. However, the pressor response is suppressed by endothelin A/B receptor antagonism. Moreover, the investigators have identified that the increase in 8-isoprostane occurs downstream of endothelin receptor activation. These data indicate that endothelin receptor activation is a main player In the pressor response to acute stress in pre-hypertensive animals; however, this phenomenon has yet to be elucidated in humans.
- Conditions
- Hypertension
- Being tested
- Bosentan, Placebo
- Keywords
- arterial stiffness, flow-mediated dilation, endothelial function, pulse wave velocity, inflammation, oxidative stress, Nitric Oxide, Cold Pressor Test, physio flow, Bosentan, Endothelin Receptor, Endothelin-1, BMI, stress, blood pressure
- Medical subject headings
- Hypertension, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BosentanDrug
Also called Tracleer
Stress response and vascular function will be assessed 3 days following 125 mg twice per day of Bosentan
PlaceboDrug
Also called lactose capsule
Stress response and vascular function will be assessed 3 days following twice per day placebo
| Study group | Role | What they receive |
|---|---|---|
| Bosentan | Experimental | Sub-Chronic (3 days) Bosentan 250mg/day. Receives: Drug: Bosentan |
| Placebo | Placebo comparator | Stress response and endothelial function will be determined following a three day treatment of placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow-Mediated Dilation (FMD)
Brachial artery FMD induced by reactive hyperemia will be used to assess vascular endothelial function.
Measured: Baseline and 3 days
Secondary outcomes (5)
Arterial Stiffness Evaluation (PWV)
A tonometer will be gently applied on the carotid artery and then the femoral artery and the radial artery to record how fast blood flows between each of the points.
Measured: Baseline and 3 days
Physio Flow
Six surface electrodes will be placed on the body. 2 on the neck, 2 on the chest, and 2 on the back in order to measure parameters of the heart during exercise.
Measured: Baseline and 3 days
Femoral blood flow
Though ultrasound assessment; resistance of the blood flow, blood flow, blood velocity, and arterial diameter will all be measured in the femoral artery during the physically induced stress test which involves submerging the subjects hand in ice water for 3 minutes.
Measured: Baseline and 3 days
Blood Pressure
Blood pressure will measured in response to the physically induced stress test which involves submerging the subjects hand in ice water for 3 minutes.
Measured: Baseline and 3 days
Resting Energy Expenditure
REE will be assessed before and following treatment
Measured: Baseline and 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2014 (estimated)
- Study startJun 2015
- Primary completionDec 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Ryan Harris, Augusta University
- Investigators
- Ryan Harris, Ph.D., Principal investigator, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02116335
- Sponsor's protocol ID
- End-Stress
- Other IDs
- 5P01HL069999
- Acronym
- End-Stress
- Status last verified
- Jan 2025
- First submitted
- 14 Apr 2014
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endothelin Receptor Function and Acute Stress (End-Stress)
- ClinicalTrials.gov ID
- NCT02116335
- Acronym / sponsor ID
- End-Stress / End-Stress
- Conditions
- Hypertension
- Keywords
- arterial stiffness, flow-mediated dilation, endothelial function, pulse wave velocity, inflammation, oxidative stress, Nitric Oxide, Cold Pressor Test
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jun 2015
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 16 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our bodies respond differently to stress. Animal studies by the investigators have found that endothelin-1 plays a role in regulating blood pressure in response to stress. This study is an extension of the investigators previous animal work to evaluate the role of endothelin-1 during stress in humans.
Detailed description
Using a salt sensitive animal model of prehypertension, the Dahl S rat,the investigators have previously published that acute stress elicits a pressor response that is accompanied by an increase in 8 isoprostane and endothelin-1. However, the pressor response is suppressed by endothelin A/B receptor antagonism. Moreover, the investigators have identified that the increase in 8-isoprostane occurs downstream of endothelin receptor activation. These data indicate that endothelin receptor activation is a main player In the pressor response to acute stress in pre-hypertensive animals; however, this phenomenon has yet to be elucidated in humans.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bosentan | Experimental | Drug: BosentanSub-Chronic (3 days) Bosentan 250mg/day. |
| Placebo | Placebo comparator | Drug: PlaceboStress response and endothelial function will be determined following a three day treatment of placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Men and premenopausal women (Ages 18-50 years old)
- Self-reported Black and White adults
- Lean adults (BMl <25 kg/m^)
- Obese adults (BMl > 30 kg/m^)
Key exclusion criteria (11 listed)
- Having a BMI less than 16 kg/m2 (severely and very severely underweight) or that is greater than 40 kg/m2 (Class III obesity)
- Having evidence of cardiovascular, pulmonary, renal, hepatic, cerebral, or metabolic disease
- Having evidence of pregnancy
- Using medications that affect vascular tone (i.e., nitrates, etc.)
- Postmenopausal women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BosentanAlso: TracleerStress response and vascular function will be assessed 3 days following 125 mg twice per day of Bosentan | Drug | Bosentan |
| PlaceboAlso: lactose capsuleStress response and vascular function will be assessed 3 days following twice per day placebo | Drug | Placebo |
Primary outcome
Flow-Mediated Dilation (FMD)
Time frame: Baseline and 3 days
Brachial artery FMD induced by reactive hyperemia will be used to assess vascular endothelial function.
5 secondary outcomes
Arterial Stiffness Evaluation (PWV)
Time frame: Baseline and 3 days
Physio Flow
Time frame: Baseline and 3 days
Femoral blood flow
Time frame: Baseline and 3 days
Blood Pressure
Time frame: Baseline and 3 days
Resting Energy Expenditure
Time frame: Baseline and 3 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Laboratory of Integrative Vascular and Exercise PhysiologyLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan Harris, Ph.D. principal investigator
Augusta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bosentan in people with Hypertension, run by Augusta University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flow-Mediated Dilation (FMD) (time frame: Baseline and 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.