A Study Examining the Effects of Nebivolol Compared to Atenolol on Endothelial Function

Launched by UNIVERSITY OF MINNESOTA · Jan 30, 2012

Keywords

ClinConnect Summary

The Rasmussen Disease Score (RDS) test panel is the chosen methodology for this study. The 10 parameters of the RDS were selected because of their ability to quantify early structural and functional abnormalities in the vasculature and left ventricle which appear long before cardiovascular disease is present.

The RDS tests include: large and small artery elasticity (measured by pulse contour analysis), resting blood pressure, mild treadmill exercise test, carotid IMT, left ventricle mass, ECG, retinal vasculature evaluation, as well as quantification of serum NT-proBNP, and microalbuminuri...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • borderline blood pressure (120-145/80-90 mm Hg);
• • borderline or abnormal small artery elasticity (C2) as measured by pulse contour analysis;
• • treatment-naive for all blood pressure medications including diuretics for at least 30 days prior to baseline visit;
• • able to walk on a treadmill for 3 minutes;
• • female patients with reproductive potential must use an approved contraceptive method if appropriate (for example, intrauterine device \[IUD\], birth control pills, or barrier device during and for 1 month after the last dose of study drug;
• • voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
• Exclusion Criteria:
• • history of intolerance to beta-blockers or clear contraindications to their use; current pharmaceutical treatment of blood pressure;
• • known history of cardiovascular disease (myocardial infarction, coronary artery bypass graft, unstable angina, uncontrolled arrhythmias, stroke, etc.);
• • known history of diabetes; known history of hepatic, renal or gastrointestinal disorder;
• • known history of any illness that may cause additional risk (as determined by study investigator);
• • pregnant or lactating women \[when used during pregnancy, beta-blockers may cause fetal harm\];
• • participation in a concomitant clinical trial.