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Active, Not Recruiting

NCT Number: NCT02116335

Endothelin Receptor Function and Acute 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Hypertension Cardiovascular Diseases Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Georgia Regents University

Augusta, Georgia, 30912, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Bosentan

Drug

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

Other names: Tracleer

Placebo

Drug

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

Other names: lactose capsule

Primary outcomes

  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 outcomes

  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.

  5. Resting Energy Expenditure

    Time frame: Baseline and 3 days

    REE will be assessed before and following treatment

Sponsors and collaborators

Lead sponsor

Augusta University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Endothelin Receptor Function and Acute Stress (End-Stress)

Acronym: End-Stress

Important dates

Study start
2015
Primary completion
2025
Study completion
2026
First posted
Apr 16, 2014
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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