Bosentan for Stress-Related High Blood Pressure

(End-Stress Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Ryan Harris, PhD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Augusta University

Approved in 5 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Ryan Harris, PhD

Principal Investigator

Augusta University

Eligibility Criteria

This trial is for Black and White adults, ages 18-50, who are either lean (BMI < 25) or obese (BMI > 30). It's not for those on low-salt diets, with severe underweight or extreme obesity issues, cardiovascular diseases, pregnant women, uncontrolled high blood pressure patients, or those taking certain medications.

Inclusion Criteria

My body mass index (BMI) is less than 25.

Self-reported Black and White adults

I am considered obese with a BMI over 30.

Exclusion Criteria

You are pregnant.

You are on a diet that limits your salt intake.

I have a heart, lung, kidney, liver, brain, or metabolic condition.

Treatment Details

Interventions

• Bosentan (Endothelin Receptor Antagonist)
• Placebo (Other)

Trial Overview The study tests how a drug called Bosentan affects blood pressure response to stress compared to a placebo. The goal is to understand the role of endothelin-1 based on previous animal studies by the investigators.

Participant Groups

Group I: Bosentan Experimental Treatment 1 Intervention

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

Group II: Placebo Placebo Group 1 Intervention

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

Bosentan is already approved in Canada, Switzerland, Japan for the following indications:

Approved in Canada as Tracleer for:

• Pulmonary arterial hypertension

Approved in Switzerland as Tracleer for:

• Pulmonary arterial hypertension

Approved in Japan as Tracleer for:

• Pulmonary arterial hypertension

Who Is Running the Clinical Trial?

Augusta University

Lead Sponsor

Trials

219

Recruited

85,900+

Dr. David C. Hess

Augusta University

Chief Executive Officer since 2017

MD from Johns Hopkins University, Neurology residency and Vascular Neurology fellowship at Augusta University

Dr. David C. Hess

Augusta University

Chief Medical Officer since 2017

MD from University of Maryland School of Medicine

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Dr. Gary H. Gibbons

National Heart, Lung, and Blood Institute (NHLBI)

Chief Executive Officer since 2012

MD from Harvard Medical School

Dr. James P. Kiley

National Heart, Lung, and Blood Institute (NHLBI)

Chief Medical Officer since 2011

MD from University of California, San Francisco