Trial Outcomes & Findings for Effects of Nebivolol on Skeletal Muscle During Exercise in Hypertensive Patients (NCT NCT01501929)

Results Overview

Endothelial cell (EC) was collected after a 20-guage angiocatheter was inserted into the contralateral forearm vein under sterile conditions. Three J-shaped vascular guidewires (St. Jude, St. Paul, MN) were advanced sequentially into the vein up to 10 cm. Endothelial cells were collected by gentle abrasion and placed into a dissociation buffer (0.5% bovine serum albumin, 2mM EDTA, and 100 ug/ml heparin in PBS). Endothelial cells were recovered from the tips of guide wires by repeated washing into collection tubes and subsequent centrifugation. EC were incubated with monoclonal antibodies against the polyclonal antibodies against NADPH oxidase p47 subunit. The intensity of staining was measured using fluorescence microscopy.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

32 participants

Primary outcome timeframe

12 weeks

Results posted on

2018-11-06

Participant Flow

32 subjects were enrolled in the study and 7 were subsequently excluded sure to various reasons, including pregnancy, normal BP of \< 120/80 mmHg after the washout period of 3 week, inability to participate, and diagnosis with cancer.

Participant milestones

Participant milestones
Measure	Metoprolol First, Then Nebivolol The subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he/she will continue for a period of 12 weeks. Then the subject will be switched to nebivolol (5-20 mg daily) for a period of 12 weeks.	Nebivolol First, Then Metoprolol The subject will be started on nebivolol (5-20 mg daily), which he/she will continue for a period of 12 weeks. Then the subject will be switched to metoprolol succinate (Toprol XL) 100-300mg daily for a period of 12 weeks.
First Intervention STARTED	8	17
First Intervention COMPLETED	8	17
First Intervention NOT COMPLETED	0	0
Second Intervention STARTED	8	17
Second Intervention COMPLETED	8	17
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Nebivolol on Skeletal Muscle During Exercise in Hypertensive Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=25 Participants After the baseline measurement, all subjects were randomized to receive either nebivolol at the dose of 5 mg once daily or Metoprolol succinate 100 mg once daily, using a double-blind crossover design. If BP remained above 140/90 mmHg during the first follow-up visit, the dose of Nebivolol was increased up to 20 mg once daily and Metoprolol was increased up to 300 mg once daily.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Endothelial cell (EC) was collected after a 20-guage angiocatheter was inserted into the contralateral forearm vein under sterile conditions. Three J-shaped vascular guidewires (St. Jude, St. Paul, MN) were advanced sequentially into the vein up to 10 cm. Endothelial cells were collected by gentle abrasion and placed into a dissociation buffer (0.5% bovine serum albumin, 2mM EDTA, and 100 ug/ml heparin in PBS). Endothelial cells were recovered from the tips of guide wires by repeated washing into collection tubes and subsequent centrifugation. EC were incubated with monoclonal antibodies against the polyclonal antibodies against NADPH oxidase p47 subunit. The intensity of staining was measured using fluorescence microscopy.

Outcome measures

Outcome measures
Measure	Metoprolol n=25 Participants The subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he/she will continue for a period of 12 weeks. The subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he or she will continue for a period of 12 weeks.	Nebivolol n=25 Participants The subject will be started on nebivolol (Bystolic) 5-20mg daily, which he or she will continue for a period of 12 weeks.
Endothelial Cell Protein Expression p47phox From Endothelial Cell Collection	0.47 Ratio human to HUVEC p47Phox expression Standard Error 0.12	0.44 Ratio human to HUVEC p47Phox expression Standard Error 0.07

PRIMARY outcome

Timeframe: 12 weeks

Microvascular perfusion of skeletal muscle were measured during handgrip at 20 cycle per minute after 12 weeks of metoprolol, and after 12 weeks of nebivolol

Outcome measures

Outcome measures
Measure	Metoprolol n=25 Participants The subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he/she will continue for a period of 12 weeks. The subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he or she will continue for a period of 12 weeks.	Nebivolol n=25 Participants The subject will be started on nebivolol (Bystolic) 5-20mg daily, which he or she will continue for a period of 12 weeks.
Microvascular Blood Flow	43.938 video intensity units/ second Interval 19.0 to 126.0	74.584 video intensity units/ second Interval 21.0 to 203.0

Adverse Events

Initial Treatment With Metoprolol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Initial Treatment With Nebivolol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Wanpen Vongpatanasin

University of Texas Southwestern

Phone: 2146482103

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place