Bosentan for Stress-Related High Blood Pressure

(End-Stress Trial)

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Augusta University

Must not be taking: Nitrates, Glyburide, Cyclosporine, others

Disqualifiers: Cardiovascular, Pulmonary, Renal, others

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 3 days

320 Participants Needed

What You Need to Know Before You Apply

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.

Will I have to stop taking my current medications?

The trial requires that you stop taking medications that affect blood vessel function, like nitrates, and those that should not be used with bosentan, such as glyburide and cyclosporine.

Is bosentan generally safe for humans?

Bosentan has been used safely in humans for conditions like pulmonary arterial hypertension, but it can cause liver issues, so regular liver function tests are needed. It may also pose risks during pregnancy, so precautions are necessary. ^{1 2 3 4 5}

What makes the drug Bosentan unique for treating stress-related high blood pressure?

Bosentan is unique because it is an oral medication that blocks endothelin receptors, which are involved in blood vessel constriction, and it is primarily used for pulmonary arterial hypertension, offering a different mechanism compared to typical blood pressure medications. Its twice-daily oral administration is convenient and avoids the discomfort of injections. ^{2 3 6 7 8}

What data supports the effectiveness of the drug Bosentan for stress-related high blood pressure?

Bosentan is effective in treating pulmonary arterial hypertension (a type of high blood pressure affecting the lungs) by improving exercise capacity and symptoms, which suggests it might help with other types of high blood pressure as well. ^{2 3 6 8 9}

Who Is on the Research Team?

Ryan Harris, PhD

Principal Investigator

Augusta University

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either placebo or Bosentan for 3 days to evaluate stress response and endothelial function

3 days

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Bosentan
• Placebo

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.

How Is the Trial Designed?

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 European Union, United States, Canada, Switzerland, Japan for the following indications:

Approved in European Union as Tracleer for:

• Pulmonary arterial hypertension

Approved in United States as Tracleer for:

• Pulmonary arterial hypertension

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+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

Bosentan is the first oral dual endothelin receptor antagonist approved for treating pulmonary arterial hypertension, significantly improving exercise capacity and symptoms in patients.

Large-scale studies have confirmed bosentan's long-term safety and tolerability, making it a crucial treatment option for pulmonary arterial hypertension and potentially other endothelin-related diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bosentan: a dual endothelin receptor antagonist. Rubin, LJ., Roux, S.[2019]

Citations

1. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[First clinical experience with endothelin receptor antagonist bosentan used in patients with pulmonary hypertension: results of a one-year study]. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Bosentan for pulmonary arterial hypertension. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Bosentan. [2018]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Bosentan: a review of its use in pulmonary arterial hypertension and systemic sclerosis. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Bosentan: a dual endothelin receptor antagonist. [2019]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Risk management strategies in the postmarketing period : safety experience with the US and European bosentan surveillance programmes. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Bosentan therapy for pulmonary arterial hypertension. [2009]

8. England pubmed.ncbi.nlm.nih.gov

Treatment of pulmonary arterial hypertension with bosentan: from pathophysiology to clinical evidence. [2019]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Bosentan: in pediatric patients with pulmonary arterial hypertension. [2021]