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Endothelin Receptor Function and Acute Stress (End-Stress)

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ClinicalTrials.gov Identifier: NCT02116335
Recruitment Status : Recruiting
First Posted : April 16, 2014
Last Update Posted : October 8, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Ryan Harris, Augusta University

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Bosentan Drug: Placebo Not Applicable

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
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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 : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Bosentan

Arms and Interventions
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Arm Intervention/treatment
Experimental: Bosentan
Sub-Chronic (3 days) Bosentan 250mg/day.
 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
 Drug: Placebo
Stress response and vascular function will be assessed 3 days following twice per day placebo
Other Name: lactose capsule


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Ryan Harris, Ph.D. 706-721-5998 ryharris@gru.edu
Contact: Jacob Looney, B.A. 706-721-5483 jlooney@gru.edu

Locations
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United States, Georgia
Georgia Regents University Recruiting
Augusta, Georgia, United States, 30912
Sponsors and Collaborators
Augusta University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Ryan Harris, Ph.D. Augusta University
More Information
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Additional Information:

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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: October 8, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Ryan Harris, Augusta University:
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
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Bosentan
 Antihypertensive Agents
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action