Endothelin Receptor Function and Acute Stress (End-Stress)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02116335|
Recruitment Status : Active, not recruiting
First Posted : April 16, 2014
Last Update Posted : November 17, 2021
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Drug: Bosentan Drug: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||320 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Endothelin Receptor Function and Acute Stress (End-Stress)|
|Study Start Date :||June 2015|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||July 2022|
Sub-Chronic (3 days) Bosentan 250mg/day.
Stress response and vascular function will be assessed 3 days following 125 mg twice per day of Bosentan
Other Name: Tracleer
Placebo Comparator: Placebo
Stress response and endothelial function will be determined following a three day treatment of placebo
Stress response and vascular function will be assessed 3 days following twice per day placebo
Other Name: lactose capsule
- 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.
- 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.
- 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.
- 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.
- 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.
- Resting Energy Expenditure [ Time Frame: Baseline and 3 days ]REE will be assessed before and following treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02116335
|United States, Georgia|
|Georgia Regents University|
|Augusta, Georgia, United States, 30912|
|Principal Investigator:||Ryan Harris, Ph.D.||Augusta University|