STRETCH Study: Effect of Distensibility on Endothelial-Dependent Vasoreactivity in Patients With ISH (NCT00277875) | Clinical Trial Compass
CompletedPhase 2
STRETCH Study: Effect of Distensibility on Endothelial-Dependent Vasoreactivity in Patients With ISH
United States25 participantsStarted 2004-02
Plain-language summary
Determine whether increasing arterial distensibility by decreasing advanced glycation end-product (AGE) cross-link components of vascular stiffness improves (a) endothelial-mediated vasoreactivity at rest, as assessed by flow-mediated vasodilation (FMD), and (b) endothelial-mediated vasoreactivity after exercise, as assessed by pulse perfusion-mediated vasodilation (PPMV).
Who can participate
Age range
50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female 50 years of age or greater.
. Diagnosed with systolic hypertension (systolic blood pressure \>140 mm Hg and (less than or equal to) 200 mm Hg, and a diastolic blood pressure (less than or equal to) 95 mm Hg) and elevated pulse pressure (systolic blood pressure \[SBP\] minus diastolic blood pressure \[DBP\] greater than 60 mm Hg).
. Normal left ventricular function (ejection fraction \>55%) at baseline (Visit 3).
. Able to perform bicycle exercise.
. Able to read, understand and sign the informed consent after the nature of the study has been explained.
. If sexually active, the patient agrees to use reliable contraception while participating in this study. If a woman, is surgically sterilized or post-menopausal, or has a negative serum pregnancy test.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Endothelial function
2
Local distensibility
3
Arterial stiffening
4
Augmentation index (AI)
5
Markers of endothelial function, vascular inflammation and collagen synthesis.
. Atrial fibrillation, diabetes mellitus treated with insulin, or chronic lung disease.
. Any additional condition(s) which, in the opinion of the investigator, would prohibit the patient from completing the study, or not be in the best interest of the patient.
. Treatment with nitrates, or a change in antihypertensive medications within the last 1 month.
. Treatment with any investigational drug within 1 month prior to study drug administration.