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Effects of Nebivolol on Skeletal Muscle During Exercise in Hypertensive Patients

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ClinicalTrials.gov Identifier: NCT01501929
Recruitment Status : Completed
First Posted : December 30, 2011
Results First Posted : November 6, 2018
Last Update Posted : November 6, 2018
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Wanpen Vongpatanasin, University of Texas Southwestern Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Hypertension
Interventions Drug: Metoprolol succinate
Drug: Nebivolol
Procedure: Non-invasive measurement of Cardiac Output (CO)
Procedure: Endothelial cell collection
Procedure: Microvascular perfusion assessment using Definity
Enrollment 32
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Metoprolol First, Then Nebivolol Nebivolol First, Then Metoprolol
Hide Arm/Group Description 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. 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.
Period Title: First Intervention
Started 8 17
Completed 8 17
Not Completed 0 0
Period Title: Second Intervention
Started 8 17
Completed 8 17
Not Completed 0 0
Arm/Group Title All Study Participants
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
<=18 years
0
   0.0%
Between 18 and 65 years
25
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Female
14
  56.0%
Male
11
  44.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants
25
1.Primary Outcome
Title Endothelial Cell Protein Expression p47phox From Endothelial Cell Collection
Hide Description 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.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metoprolol Nebivolol
Hide Arm/Group Description:
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.
The subject will be started on nebivolol (Bystolic) 5-20mg daily, which he or she will continue for a period of 12 weeks.
Overall Number of Participants Analyzed 25 25
Mean (Standard Error)
Unit of Measure: Ratio human to HUVEC p47Phox expression
0.47  (0.12) 0.44  (0.07)
2.Primary Outcome
Title Microvascular Blood Flow
Hide Description 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
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metoprolol Nebivolol
Hide Arm/Group Description:
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.
The subject will be started on nebivolol (Bystolic) 5-20mg daily, which he or she will continue for a period of 12 weeks.
Overall Number of Participants Analyzed 25 25
Median (Inter-Quartile Range)
Unit of Measure: video intensity units/ second
43.938
(19 to 126)
74.584
(21 to 203)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Initial Treatment With Metoprolol Initial Treatment With Nebivolol
Hide Arm/Group Description 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. The subject will be started on nebivolol (Bystolic) 5-20mg daily, which he or she will continue for a period of 12 weeks.
All-Cause Mortality
Initial Treatment With Metoprolol Initial Treatment With Nebivolol
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/25 (0.00%) 
Hide Serious Adverse Events
Initial Treatment With Metoprolol Initial Treatment With Nebivolol
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/25 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Initial Treatment With Metoprolol Initial Treatment With Nebivolol
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/25 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Wanpen Vongpatanasin
Organization: University of Texas Southwestern
Phone: 2146482103
EMail: Wanpen.Vongpatanasin@UTSouthwestern.edu
Publications:
Layout table for additonal information
Responsible Party: Wanpen Vongpatanasin, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01501929    
Other Study ID Numbers: Bystolic MD52
First Submitted: November 29, 2011
First Posted: December 30, 2011
Results First Submitted: May 11, 2018
Results First Posted: November 6, 2018
Last Update Posted: November 6, 2018