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 range50 Years
SexALL
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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.
Exclusion criteria
✕. Aortic stenosis, prior known coronary artery disease (including myocardial infarction), cerebrovascular accident, or peripheral vascular disease.
✕. 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.
✕
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.