Clinical trial NCT01595516: Nebivolol and Endothelial Regulation of Fibrinolysis (NERF)
Official title: Nebivolol and Endothelial Regulation of Fibrinolysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Prehypertension
Hypertension
Lead sponsor: University of Colorado, Boulder
Sponsor class: OTHER
Collaborators: name: Forest Laboratories
First posted: 2012-05-10
Enrollment: 44
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Subjects will be men and women of all races and ethnic backgrounds aged 45-65 years.
* Subjects will be prehypertensive/hypertensive defined as resting systolic blood pressure \>125 mmHg and \<160 mmHg and/or diastolic \>80 mmHg and \<100 mmHg.
* All of the women in the study will be postmenopausal and not receiving hormone replacement therapy (HRT) currently or in the preceding 3-year period.
* Candidates will be sedentary as determined from the Stanford Physical Activity Questionnaire (\<35 kcal/wk) and will not have engaged in any program of regular physical activity for at least 1 year prior to the study.

Exclusion Criteria:

* Candidates who smoke (currently or in the past 7 years), report more than low-risk alcohol consumption as defined as no more than 14 standard drinks/wk and no more than 4 standard drinks/day for men and 7 standard drinks/wk and 3 standard drinks/day for women (a standard drink is defined as 12 ounces of beer, 5 ounces of wine, 1½ ounces of 80-proof distilled spirits).
* Potential candidates who are taking cardiovascular-acting (i.e. statins, blood pressure medication and aspirin) medications will not be eligible.
* Fasting plasma glucose \>126 mg/dL.
* Potential candidates with a resting heart rate of \< 50 beats/minute will be excluded.
* Use of hormone replacement therapy.
* In hypertensive subjects, a seated systolic blood pressure \>160 mmHg or a seated diastolic blood pressure \>100 mmHg will be excluded.

Primary outcomes:
measure: Heart Rate
timeFrame: Heart rate was measured before the 12 week drug or placebo intervention and after the 12 week drug or placebo intervention.
measure: Systolic Blood Pressure
timeFrame: Systolic blood pressure was measured before the 12 week drug or placebo intervention and after the 12 week drug or placebo intervention.
measure: Diastolic Blood Pressure
timeFrame: Diastolic blood pressure was measured before the 12 week drug or placebo intervention and after the 12 week drug or placebo intervention.
measure: Endothelial t-PA Release in Response to Bradykinin (BDK) Before and After the 12 Week Intervention
timeFrame: t-PA release was measured before the 12 week drug or placebo intervention and after the 12 week drug or placebo intervention.
measure: Endothelial t-PA Release in Response to Bradykinin (BDK) and Bradykinin+Vitamin C (BDK+C) Before and After 12 Weeks of Nebivolol Therapy.
timeFrame: t-PA release was measured before the 12 week drug intervention and after the 12 week drug intervention.
measure: Endothelial t-PA Release in Response to BDK and BDK+C Before and After 12 Weeks of Metoprolol Therapy.
timeFrame: t-PA release was measured before the 12 week drug intervention and after the 12 week drug intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: Boulder
country: United States
facility: UC-Boulder Clinical and Translational Research Center
state: Colorado
Study officials:
affiliation: University of Colorado at Boulder
name: Christopher DeSouza, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stauffer BL, Dow CA, Diehl KJ, Bammert TD, Greiner JJ, DeSouza CA. Nebivolol, But Not Metoprolol, Treatment Improves Endothelial Fibrinolytic Capacity in Adults With Elevated Blood Pressure. J Am Heart Assoc. 2017 Nov 9;6(11):e007437. doi: 10.1161/JAHA.117.007437.