NCT02116335

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
320

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Jun 2015

Longer than P75 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 16, 2014

Completed
1.1 years until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
10.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

January 28, 2025

Status Verified

January 1, 2025

Enrollment Period

10.5 years

First QC Date

April 14, 2014

Last Update Submit

January 27, 2025

Conditions

Hypertension

Keywords

arterial stiffnessflow-mediated dilationendothelial functionpulse wave velocityinflammationoxidative stressNitric OxideCold Pressor Testphysio flowBosentanEndothelin ReceptorEndothelin-1BMIstressblood pressure

Outcome Measures

Primary Outcomes (1)

  • Flow-Mediated Dilation (FMD)

    Brachial artery FMD induced by reactive hyperemia will be used to assess vascular endothelial function.

    Baseline and 3 days

Secondary Outcomes (5)

  • Arterial Stiffness Evaluation (PWV)

    Baseline and 3 days

  • Physio Flow

    Baseline and 3 days

  • Femoral blood flow

    Baseline and 3 days

  • Blood Pressure

    Baseline and 3 days

  • Resting Energy Expenditure

    Baseline and 3 days

Study Arms (2)

Bosentan

EXPERIMENTAL

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

Drug: Bosentan

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

BosentanDRUG

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

Also known as: Tracleer
Bosentan
PlaceboDRUG

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

Also known as: lactose capsule
Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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\^)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Georgia Regents University

Augusta, Georgia, 30912, United States

Location

Related Links

MeSH Terms

Conditions

HypertensionInflammation

Interventions

BosentanLactose

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugars

Study Officials

  • Ryan Harris, Ph.D.

    Augusta University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 14, 2014

First Posted

April 16, 2014

Study Start

June 1, 2015

Primary Completion

December 1, 2025

Study Completion

January 1, 2026

Last Updated

January 28, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

Locations

US(1)