Endothelin Receptor Function and Acute Stress (End-Stress)
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ClinicalTrials.gov Identifier: NCT02116335 |
Recruitment Status :
Active, not recruiting
First Posted : April 16, 2014
Last Update Posted : November 17, 2021
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Condition or disease | Intervention/treatment | Phase |
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Hypertension | Drug: Bosentan Drug: Placebo | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 320 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Endothelin Receptor Function and Acute Stress (End-Stress) |
Study Start Date : | June 2015 |
Estimated Primary Completion Date : | December 2021 |
Estimated Study Completion Date : | July 2022 |

Arm | Intervention/treatment |
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Experimental: Bosentan
Sub-Chronic (3 days) Bosentan 250mg/day.
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Drug: Bosentan
Stress response and vascular function will be assessed 3 days following 125 mg twice per day of Bosentan
Other Name: Tracleer |
Placebo Comparator: Placebo
Stress response and endothelial function will be determined following a three day treatment of placebo
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Drug: Placebo
Stress response and vascular function will be assessed 3 days following twice per day placebo
Other Name: lactose capsule |
- 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.
- Arterial Stiffness Evaluation (PWV) [ Time Frame: Baseline and 3 days ]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.
- Physio Flow [ Time Frame: Baseline and 3 days ]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.
- Femoral blood flow [ Time Frame: Baseline and 3 days ]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.
- Blood Pressure [ Time Frame: Baseline and 3 days ]Blood pressure will measured in response to the physically induced stress test which involves submerging the subjects hand in ice water for 3 minutes.
- Resting Energy Expenditure [ Time Frame: Baseline and 3 days ]REE will be assessed before and following treatment

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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^)
Exclusion Criteria:
- 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
- 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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02116335
United States, Georgia | |
Georgia Regents University | |
Augusta, Georgia, United States, 30912 |
Principal Investigator: | Ryan Harris, Ph.D. | Augusta University |
Responsible Party: | Ryan Harris, Assistant Professor, Augusta University |
ClinicalTrials.gov Identifier: | NCT02116335 |
Other Study ID Numbers: |
End-Stress 5P01HL069999 ( U.S. NIH Grant/Contract ) |
First Posted: | April 16, 2014 Key Record Dates |
Last Update Posted: | November 17, 2021 |
Last Verified: | November 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
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 |
Hypertension Vascular Diseases Cardiovascular Diseases Bosentan |
Antihypertensive Agents Endothelin Receptor Antagonists Molecular Mechanisms of Pharmacological Action |