Endothelin Receptor Function and Acute Stress

Hypertension Clinical Trial

— End-Stress  

Official title:

Endothelin Receptor Function and Acute Stress (End-Stress)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02116335
• Other study ID #: End-Stress
• Secondary ID: 5P01HL069999
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 2015
• Est. completion date: January 2026

Study information

• Verified date: January 2024
• Source: Augusta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 320
• Est. completion date: January 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Bosentan
Stress response and vascular function will be assessed 3 days following 125 mg twice per day of Bosentan
• Placebo
Stress response and vascular function will be assessed 3 days following twice per day placebo

Locations

Country	Name	City	State
United States	Georgia Regents University	Augusta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Augusta University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flow-Mediated Dilation (FMD)	Brachial artery FMD induced by reactive hyperemia will be used to assess vascular endothelial function.	Baseline and 3 days
Secondary	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.	Baseline and 3 days
Secondary	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.	Baseline and 3 days
Secondary	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.	Baseline and 3 days
Secondary	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.	Baseline and 3 days
Secondary	Resting Energy Expenditure	REE will be assessed before and following treatment	Baseline and 3 days

External Links

•   Laboratory of Integrative Vascular and Exercise Physiology