HypertensionPhase 4NCT01920282
Nebivolol, Lifestyle Modification and Arterial Stiffness
A Phase 4 study testing Nebivolol, Lifestyle Modification and Nebivolol plus Lifestyle Modification in people with Hypertension, run by Virginia Polytechnic Institute and State University.
Trial summary
Numerous anti-hypertensive drugs have been reported to be efficacious in reducing central arterial stiffness and these effects may contribute to improved outcomes in hypertensive patients. However, the results of several studies suggest that beta-blockers may actually increase arterial stiffness. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Nebivolol, Lifestyle Modification and Nebivolol plus Lifestyle Modification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Aug 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage 1 hypertension
- 40-75 years
- Weight stable (+/-2 kg)
- Sedentary to recreationally active
- Willing to be randomized to one of three arms
- Verbal and written consent
- Approval by medical director
Who cannot join
- Blood pressure outside stated range
- Diabetes or taking diabetes medications
- Total cholesterol >6.2 mmol/L; triglycerides >4.5 mmol/L
- Past or current ischemic heart disease, stroke, respiratory disease, endocrine or metabolic disease, neurological disease, or hematological-oncological disease
- Medications (including but not limited to antihypertensives, statins or other with anti-inflammatory actions) or antioxidant vitamins or supplements
- Known allergy or hypersensitivity to nebivolol or any of its components
- Inability to perform regular physical activity or participate in other components of lifestyle modification
- Pregnant or planning to become pregnant
About this study
Official title: Effect of Nebivolol and Lifestyle Modification on Large Artery Stiffness in Middle-Aged and Older Hypertensive Adults
Numerous anti-hypertensive drugs have been reported to be efficacious in reducing central arterial stiffness and these effects may contribute to improved outcomes in hypertensive patients. However, the results of several studies suggest that beta-blockers may actually increase arterial stiffness. In contrast, there is limited evidence to suggest that nebivolol, a third generation beta-blocker that augments release of vascular nitric oxide, reduces central arterial stiffness in hypertensive individuals. Unfortunately, only a few studies have addressed this issue and all of these studies relied on indirect, blood pressure dependent measures of arterial stiffness. In addition, none of these studies focused on middle-aged and older, obese hypertensives, a population with accelerated arterial stiffening and at risk for cardiovascular diseases. Thus, the potential utility of nebivolol as a therapy to reduce large artery stiffness, particularly among the latter population, remains unclear.
- Conditions
- Hypertension
- Being tested
- Nebivolol, Lifestyle Modification, Nebivolol plus Lifestyle Modification
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NebivololDrug
Also called Bystolic
Lifestyle ModificationOther
Also called Weight loss, Sodium restriction, Physical activity
Nebivolol plus Lifestyle ModificationOther
Also called Bsytolic, Weight Loss, Sodium restriction, Physical activity
| Study group | Role | What they receive |
|---|---|---|
| Nebivolol | Active comparator | 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. Receives: Drug: Nebivolol |
| Lifestyle Modification | Active comparator | 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 are 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 protein. Sodium consumption was set at 2,400 mg/day for all subjects. Receives: Other: Lifestyle Modification |
| Nebivolol plus Lifestyle Modification | Experimental | Subjects begin with 5 mg/day of nebivolol and increase to 10 mg/day if brachial blood pressure is greater than 120/80 mmHg during the first 2 weeks of therapy. Subjects also 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 are provided to each individual. Individuals will be instructed to reduce their daily caloric intake by 500-1000 calories and to perform a minimum of 150 min/wk of moderate-intensity physical activity or 3000 steps/day above baseline levels. The diet plan conforms to the Dietary Approaches to Stop Hypertension dietary guidelines emphasizing low fat dairy products, fruits and vegetable and contains 55% calories as carbohydrates, 30% calories as fat, and 15% calories as protein with sodium consumption set at 2,400 mg/day for all subjects. Receives: Other: Nebivolol plus Lifestyle Modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beta-stiffness Index
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.
Measured: 12 weeks
Secondary outcomes (1)
Insulin Sensitivity (HOMA-IR)
The HOMA index was calculated as the product of plasma blood glucose and insulin divided by 22.5.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2013 (estimated)
- Study startJan 2010
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Polytechnic Institute and State University
- Sponsor type
- University, hospital or other
- Collaborators
- Forest Laboratories
- Responsible party
- Principal investigator, Kevin Davy, Virginia Polytechnic Institute and State University
- Investigators
- Kevin P Davy, Ph.D., Principal investigator, Virginia Polytechnic Institute and State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01920282
- Sponsor's protocol ID
- nebstiff
- Status last verified
- Jan 2018
- First submitted
- 18 Jul 2013
- Last updated
- 23 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nebivolol and Lifestyle Modification on Large Artery Stiffness in Middle-Aged and Older Hypertensive Adults
- ClinicalTrials.gov ID
- NCT01920282
- Acronym / sponsor ID
- nebstiff
- Conditions
- Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
- Collaborators
- Forest Laboratories
- Study start
- Jan 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 9 Aug 2013 (estimated)
- Results
- Posted 2 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Numerous anti-hypertensive drugs have been reported to be efficacious in reducing central arterial stiffness and these effects may contribute to improved outcomes in hypertensive patients. However, the results of several studies suggest that beta-blockers may actually increase arterial stiffness. In contrast, there is limited evidence to suggest that nebivolol, a third generation beta-blocker that augments release of vascular nitric oxide, reduces central arterial stiffness in hypertensive individuals. Unfortunately, only a few studies have addressed this issue and all of these studies relied on indirect, blood pressure dependent measures of arterial stiffness. In addition, none of these studies focused on middle-aged and older, obese hypertensives, a population with accelerated arterial stiffening and at risk for cardiovascular diseases. Thus, the potential utility of nebivolol as a therapy to reduce large artery stiffness, particularly among the latter population, remains unclear.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nebivolol | Active comparator | Drug: NebivololSubjects 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. |
| Lifestyle Modification | Active comparator | Other: Lifestyle ModificationSubjects 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 are 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 protein. Sodium consumption was set at 2,400 mg/day for all subjects. |
| Nebivolol plus Lifestyle Modification | Experimental | Other: Nebivolol plus Lifestyle ModificationSubjects begin with 5 mg/day of nebivolol and increase to 10 mg/day if brachial blood pressure is greater than 120/80 mmHg during the first 2 weeks of therapy. Subjects also 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 are provided to each individual. Individuals will be instructed to reduce their daily caloric intake by 500-1000 calories and to perform a minimum of 150 min/wk of moderate-intensity physical activity or 3000 steps/day above baseline levels. The diet plan conforms to the Dietary Approaches to Stop Hypertension dietary guidelines emphasizing low fat dairy products, fruits and vegetable and contains 55% calories as carbohydrates, 30% calories as fat, and 15% calories as protein with sodium consumption set at 2,400 mg/day for all subjects. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Stage 1 hypertension
- 40-75 years
- Weight stable (+/-2 kg)
- Sedentary to recreationally active
- Willing to be randomized to one of three arms
Key exclusion criteria (8 listed)
- Blood pressure outside stated range
- Diabetes or taking diabetes medications
- Total cholesterol >6.2 mmol/L; triglycerides >4.5 mmol/L
- Past or current ischemic heart disease, stroke, respiratory disease, endocrine or metabolic disease, neurological disease, or hematological-oncological disease
- Medications (including but not limited to antihypertensives, statins or other with anti-inflammatory actions) or antioxidant vitamins or supplements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NebivololAlso: Bystolic | Drug | Nebivolol |
| Lifestyle ModificationAlso: Weight loss, Sodium restriction, Physical activity | Other | Lifestyle Modification |
| Nebivolol plus Lifestyle ModificationAlso: Bsytolic, Weight Loss, Sodium restriction, Physical activity | Other | Nebivolol plus Lifestyle Modification |
Primary outcome
Beta-stiffness Index
Time frame: 12 weeks
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.
1 secondary outcome
Insulin Sensitivity (HOMA-IR)
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin P Davy, Ph.D. principal investigator
Virginia Polytechnic Institute and State University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nebivolol, Lifestyle Modification and Nebivolol plus Lifestyle Modification in people with Hypertension, run by Virginia Polytechnic Institute and State University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beta-stiffness Index (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2018.