NCT01595516

Nebivolol and Endothelial Regulation of Fibrinolysis (NERF)

Nebivolol and Endothelial Regulation of Fibrinolysis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: University of Colorado, Boulder · Academic / Other
• Sex: All
• Age: 45 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The investigators hypothesize that nebivolol will improve endothelial t-PA release in adult humans with elevated blood pressure to a greater extent than either metoprolol or placebo. The investigators further hypothesize that the improvement in the capacity of the vascular endothelium to release t-PA with nebivolol is mediated, in part, by the compound's antioxidant properties.

Conditions

• Prehypertension
• Hypertension

Interventions

Type	Name	Description
DRUG	Nebivolol	5 mg tablet to be taken by mouth once per day for 12 weeks
DRUG	Metoprolol	100 mg tablet to be taken by mouth once per day for 12 weeks
DRUG	Placebo	Gelatin capsule to be taken by mouth once per day for 12 weeks
OTHER	Bradykinin	Bradykinin is infused into the brachial artery at doses of 12.5, 25.0 and 50.0 ng/100 mL of forearm tissue /min. BDK stimulates the endothelial cells to release tissue type plasminogen activator (t-PA). Blood flow in mL/100 mL tissue/min is also measured to BDK.
OTHER	Saline	Baseline or resting forearm blood flow is measured in response to saline for 5 minutes before each drug infusion. t-PA release in response to the saline is also measured.
OTHER	Vitamin C	The acute effects of into-arterial vitamin C on the ability of the endothelium to release t-PA was determined before and after the nebivolol and metoprolol intervention. After allowing sufficient time (\~20 minutes) for FBF and plasma t-PA concentrations to return to baseline following the initial infusion of BDK, vitamin C (24 mg/min) was infused at a constant rate while the BDK dose-response curves were repeated. t-PA and FBF were measured.

Timeline

• Start date: 2012-02-01
• Primary completion: 2017-10-01
• Completion: 2017-10-01
• First posted: 2012-05-10
• Last updated: 2019-06-25
• Results posted: 2019-06-25

Locations

1 site across 1 country: United States