Endothelin Receptor Function and Acute Stress

NCT ID: NCT02116335

Last Updated: 2025-01-28

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2026-01-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Bosentan

Sub-Chronic (3 days) Bosentan 250mg/day.

Group Type: EXPERIMENTAL

Bosentan

Intervention Type: DRUG

Stress response and vascular function will be assessed 3 days following 125 mg twice per day of Bosentan

Placebo

Stress response and endothelial function will be determined following a three day treatment of placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Stress response and vascular function will be assessed 3 days following twice per day placebo

Interventions

Bosentan

Stress response and vascular function will be assessed 3 days following 125 mg twice per day of Bosentan

Intervention Type: DRUG

Placebo

Stress response and vascular function will be assessed 3 days following twice per day placebo

Intervention Type: DRUG

Other Intervention Names

Tracleer; lactose capsule

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Augusta University

OTHER

Sponsor Role: lead

Responsible Party

Ryan Harris

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ryan Harris, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Augusta University

Locations

Georgia Regents University

Augusta, Georgia, United States

Countries

United States

Related Links

http://www.livep.net

Laboratory of Integrative Vascular and Exercise Physiology

Other Identifiers

5P01HL069999

Identifier Type: NIH

Identifier Source: secondary_id

View Link

End-Stress

Identifier Type: -

Identifier Source: org_study_id