Trial Outcomes & Findings for Nebivolol, Lifestyle Modification and Arterial Stiffness (NCT NCT01920282)
NCT ID: NCT01920282
Last Updated: 2018-02-23
Results Overview
Longitudinal B-mode images of the left common carotid artery diameter (1-2 cm proximal to the carotid bulb) were obtained over 15 consecutive cardiac cycles. Brachial blood pressure was measured via an automated sphygmomanometer. Quantification of systolic and diastolic carotid artery diameters were analyzed with the Vascular Research Tools 5 software program. Beta-stiffness index was calculated as: Beta = ln(P1/P0)/((D1-D0)/D0), where D0 represents the minimal diameter recorded during diastole, D1 represents the maximal diameter recorded during systole, P0 represents the pressure measured during diastole, and P1 represents the pressure measured during systole.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
45 participants
Primary outcome timeframe
12 weeks
Results posted on
2018-02-23
Participant Flow
Participant milestones
| Measure |
Nebivolol
Subjects will be provided with daily 5 mg of nebivolol for the first 2 weeks. Subjects receive additional daily doses of 10 mg nebivolol for the remainder of the study period. The dose remains at 5 mg per day, however, if BP falls below 110/70 during the first 2 weeks. Subjects will continue taking the drug during the 2-week follow-up period.
Nebivolol
|
Lifestyle Modification
Subjects will receive weekly lifestyle counseling by a registered dietitian to ensure adequate progress and compliance. Sample menus, 14-days of meal plans, and grocery shopping lists were provided to each individual. Individuals were instructed to reduce their daily caloric intake by 500-1000 calories and to perform a minimum of 150 minutes per week of moderate-intensity physical activity or 3000 steps/day above baseline levels. The diet plan conformed to the Dietary Approach to Stop Hypertension dietary guidelines emphasizing low fat dairy products, fruits and vegetable and contained 55% calories as carbohydrates, 30% calories as fat, and 15% calories as protein21. Sodium consumption was set at 2,400 mg/day for all subjects.
Lifestyle Modification
|
Nebivolol Plus Lifestyle Modification
Subjects began with 5 mg/day of nebivolol and increased to 10 mg/day if brachial blood pressure was greater than 120/80 mmHg during the first two weeks of therapy. Subjects also received weekly lifestyle counseling by a registered dietitian to ensure adequate progress and compliance. Sample menus, 14-days of meal plans, and grocery shopping lists were provided to each individual. Individuals were instructed to reduce their daily caloric intake by 500-1000 calories and to perform a minimum of 150 minutes per week of moderate-intensity physical activity or 3000 steps/day above baseline levels. The diet plan conformed to the Dietary Approaches to Stop Hypertension dietary guidelines emphasizing low fat dairy products, fruits and vegetable and contained 55% calories as carbohydrates, 30% calories as fat, and 15% calories as protein21. Sodium consumption was set at 2,400 mg/day for all subjects.
Nebivolol plus Lifestyle Modification
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nebivolol, Lifestyle Modification and Arterial Stiffness
Baseline characteristics by cohort
| Measure |
Nebivolol
n=15 Participants
Subjects will be provided with daily 5 mg of nebivolol for the first 2 weeks. Subjects receive additional daily doses of 10 mg nebivolol for the remainder of the study period. The dose remains at 5 mg per day, however, if BP falls below 110/70 during the first 2 weeks. Subjects will continue taking the drug during the 2-week follow-up period.
Nebivolol
|
Lifestyle Modification
n=15 Participants
Subjects will receive weekly lifestyle counseling by a registered dietitian to ensure adequate progress and compliance. Sample menus, 14-days of meal plans, and grocery shopping lists were provided to each individual. Individuals were instructed to reduce their daily caloric intake by 500-1000 calories and to perform a minimum of 150 minutes per week of moderate-intensity physical activity or 3000 steps/day above baseline levels. The diet plan conformed to the Dietary Approach to Stop Hypertension dietary guidelines emphasizing low fat dairy products, fruits and vegetable and contained 55% calories as carbohydrates, 30% calories as fat, and 15% calories as protein21. Sodium consumption was set at 2,400 mg/day for all subjects.
Lifestyle Modification
|
Nebivolol Plus Lifestyle Modification
n=15 Participants
Subjects began with 5 mg/day of nebivolol and increased to 10 mg/day if brachial blood pressure was greater than 120/80 mmHg during the first two weeks of therapy. Subjects also received weekly lifestyle counseling by a registered dietitian to ensure adequate progress and compliance. Sample menus, 14-days of meal plans, and grocery shopping lists were provided to each individual. Individuals were instructed to reduce their daily caloric intake by 500-1000 calories and to perform a minimum of 150 minutes per week of moderate-intensity physical activity or 3000 steps/day above baseline levels. The diet plan conformed to the Dietary Approaches to Stop Hypertension dietary guidelines emphasizing low fat dairy products, fruits and vegetable and contained 55% calories as carbohydrates, 30% calories as fat, and 15% calories as protein21. Sodium consumption was set at 2,400 mg/day for all subjects.
Nebivolol plus Lifestyle Modification
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
57.7 yr
STANDARD_DEVIATION 3.1 • n=5 Participants
|
52.7 yr
STANDARD_DEVIATION 2.2 • n=7 Participants
|
58.4 yr
STANDARD_DEVIATION 2.2 • n=5 Participants
|
56.3 yr
STANDARD_DEVIATION 2.5 • n=4 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
15 participants
n=5 Participants
|
45 participants
n=4 Participants
|
|
Supine blood pressure (mmHg)
|
146 mmHg
STANDARD_DEVIATION 1.4 • n=5 Participants
|
138 mmHg
STANDARD_DEVIATION 3.1 • n=7 Participants
|
142 mmHg
STANDARD_DEVIATION 2.6 • n=5 Participants
|
142 mmHg
STANDARD_DEVIATION 2.37 • n=4 Participants
|
|
Supine heart rate (bpm)
|
64 bpm
STANDARD_DEVIATION 1 • n=5 Participants
|
67 bpm
STANDARD_DEVIATION 3 • n=7 Participants
|
66 bpm
STANDARD_DEVIATION 2 • n=5 Participants
|
66 bpm
STANDARD_DEVIATION 2 • n=4 Participants
|
PRIMARY outcome
Timeframe: 12 weeksLongitudinal B-mode images of the left common carotid artery diameter (1-2 cm proximal to the carotid bulb) were obtained over 15 consecutive cardiac cycles. Brachial blood pressure was measured via an automated sphygmomanometer. Quantification of systolic and diastolic carotid artery diameters were analyzed with the Vascular Research Tools 5 software program. Beta-stiffness index was calculated as: Beta = ln(P1/P0)/((D1-D0)/D0), where D0 represents the minimal diameter recorded during diastole, D1 represents the maximal diameter recorded during systole, P0 represents the pressure measured during diastole, and P1 represents the pressure measured during systole.
Outcome measures
| Measure |
Nebivolol
n=15 Participants
Subjects will be provided with daily 5 mg of nebivolol for the first 2 weeks. Subjects receive additional daily doses of 10 mg nebivolol for the remainder of the study period. The dose remains at 5 mg per day, however, if BP falls below 110/70 during the first 2 weeks. Subjects will continue taking the drug during the 2-week follow-up period.
Nebivolol
|
Lifestyle Modification
n=15 Participants
Subjects will receive weekly lifestyle counseling by a registered dietitian to ensure adequate progress and compliance. Sample menus, 14-days of meal plans, and grocery shopping lists were provided to each individual. Individuals were instructed to reduce their daily caloric intake by 500-1000 calories and to perform a minimum of 150 minutes per week of moderate-intensity physical activity or 3000 steps/day above baseline levels. The diet plan conformed to the Dietary Approach to Stop Hypertension dietary guidelines emphasizing low fat dairy products, fruits and vegetable and contained 55% calories as carbohydrates, 30% calories as fat, and 15% calories as protein21. Sodium consumption was set at 2,400 mg/day for all subjects.
Lifestyle Modification
|
Nebivolol Plus Lifestyle Modification
n=15 Participants
Subjects began with 5 mg/day of nebivolol and increased to 10 mg/day if brachial blood pressure was greater than 120/80 mmHg during the first two weeks of therapy. Subjects also received weekly lifestyle counseling by a registered dietitian to ensure adequate progress and compliance. Sample menus, 14-days of meal plans, and grocery shopping lists were provided to each individual. Individuals were instructed to reduce their daily caloric intake by 500-1000 calories and to perform a minimum of 150 minutes per week of moderate-intensity physical activity or 3000 steps/day above baseline levels. The diet plan conformed to the Dietary Approaches to Stop Hypertension dietary guidelines emphasizing low fat dairy products, fruits and vegetable and contained 55% calories as carbohydrates, 30% calories as fat, and 15% calories as protein21. Sodium consumption was set at 2,400 mg/day for all subjects.
Nebivolol plus Lifestyle Modification
|
|---|---|---|---|
|
Beta-stiffness Index
|
-2.03 Arbitrary units
Standard Error 0.6
|
-1.87 Arbitrary units
Standard Error 0.83
|
-2.51 Arbitrary units
Standard Error 0.9
|
SECONDARY outcome
Timeframe: 12 weeksThe HOMA index was calculated as the product of plasma blood glucose and insulin divided by 22.5.
Outcome measures
| Measure |
Nebivolol
n=15 Participants
Subjects will be provided with daily 5 mg of nebivolol for the first 2 weeks. Subjects receive additional daily doses of 10 mg nebivolol for the remainder of the study period. The dose remains at 5 mg per day, however, if BP falls below 110/70 during the first 2 weeks. Subjects will continue taking the drug during the 2-week follow-up period.
Nebivolol
|
Lifestyle Modification
n=15 Participants
Subjects will receive weekly lifestyle counseling by a registered dietitian to ensure adequate progress and compliance. Sample menus, 14-days of meal plans, and grocery shopping lists were provided to each individual. Individuals were instructed to reduce their daily caloric intake by 500-1000 calories and to perform a minimum of 150 minutes per week of moderate-intensity physical activity or 3000 steps/day above baseline levels. The diet plan conformed to the Dietary Approach to Stop Hypertension dietary guidelines emphasizing low fat dairy products, fruits and vegetable and contained 55% calories as carbohydrates, 30% calories as fat, and 15% calories as protein21. Sodium consumption was set at 2,400 mg/day for all subjects.
Lifestyle Modification
|
Nebivolol Plus Lifestyle Modification
n=15 Participants
Subjects began with 5 mg/day of nebivolol and increased to 10 mg/day if brachial blood pressure was greater than 120/80 mmHg during the first two weeks of therapy. Subjects also received weekly lifestyle counseling by a registered dietitian to ensure adequate progress and compliance. Sample menus, 14-days of meal plans, and grocery shopping lists were provided to each individual. Individuals were instructed to reduce their daily caloric intake by 500-1000 calories and to perform a minimum of 150 minutes per week of moderate-intensity physical activity or 3000 steps/day above baseline levels. The diet plan conformed to the Dietary Approaches to Stop Hypertension dietary guidelines emphasizing low fat dairy products, fruits and vegetable and contained 55% calories as carbohydrates, 30% calories as fat, and 15% calories as protein21. Sodium consumption was set at 2,400 mg/day for all subjects.
Nebivolol plus Lifestyle Modification
|
|---|---|---|---|
|
Insulin Sensitivity (HOMA-IR)
|
-0.36 Arbitrary units
Standard Error 0.33
|
-1.98 Arbitrary units
Standard Error 1.43
|
-2.12 Arbitrary units
Standard Error 0.73
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksOutcome measures
Outcome data not reported
Adverse Events
Nebivolol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Lifestyle Modification
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Nebivolol Plus Lifestyle Modification
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place