HypertensionNCT01056718

Effects of Nebivolol on Exercise Tolerance and Left Ventricular Systolic and Diastolic Function

A study testing Nebivolol in people with Hypertension, run by Mercy Research at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 90 years
Conditions the study is for: Hypertension
What is being tested?: Nebivolol
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 53 participants
Where: 1 siteUnited States
Study dates: Nov 2009to May 2014
Phase: Interventional
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 18 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis (new or established) hypertension, defined by serial measurements >/= 140/90
Evidence of diastolic dysfunction on echocardiography measured by tissue Doppler

Who cannot join

Severe bronchospastic disease/ reactive airway disease
Inability to tolerate beta blocker therapy including: >1st degree atrioventricular (AV) block, symptomatic hypotension, symptomatic bradycardia,
Subjects with physical limitations that would prevent them from participating in an exercise treadmill test
Age <18 or >90 years
Those with life expectancy <1 year
Subjects with class III/IV New York Heart Association (NYHA) heart failure symptoms
Chronic Kidney Disease 3 or greater (CrCl <30 cc/min)
Subjects with active ischemia or evidence of ischemia on initial stress echocardiography

Trial locations and contacts

1 site in 1 country.

United States1 site

St. John's Mercy Cardiovascular Research
St Louis, Missouri, 63141

Other trials in United States

About this study

The goal of this pilot study is to effectively treat hypertension in subjects with either known or newly diagnosed hypertension and concurrent evidence of diastolic dysfunction. Due to the unique properties of nebivolol, it is hypothesized that there will be improvements in left ventricular (LV) systolic and diastolic function manifesting as increase exercise capacity in this patient population with primarily LV diastolic dysfunction. The present study was performed to determine the effects of nebivolol on blood pressure, exercise tolerance and parameters of left ventricular systolic and diastolic function in a group of hypertensive patients with echocardiographic evidence diastolic dysfunction.

Read the detailed description

Prior to the initiation of Nebivolol and after 10 weeks of Nebivolol therapy, subjects underwent a resting 2D echocardiogram including routine sampling of mitral valve (MV) inflow and LV tissue Doppler imaging as well as a symptom limited exercise treadmill stress test with echocardiographic imaging. Primary endpoints were 1) changes in systolic blood pressure before and after 10 weeks of treatment and 2) changes in exercise capacity as determined by exercise duration and metabolic equivalent (MET) level before and after treatment. Secondary endpoints were changes in exercise hemodynamics and Doppler echocardiographic parameters of LV systolic and diastolic function and quality of life before and after 10 weeks of nebivolol treatment. Subjects completed an EuroQol (EQ-SD) Quality of Life questionnaire which is a standardized measure of health status developed by the EuroQol group as a simple general measure of health at baseline and at conclusion of the 10 week trial period.

Conditions: Hypertension
Being tested: Nebivolol
Keywords: Diastolic Function, Nebivolol
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NebivololDrug
Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure. The dose was titrated by doubling the previous dosage to achieve BP less than or equal to 130/80 mm Hg at 2 weeks and 4 weeks. The mean dose of nebivolol used week 4 through week 10 was 7.8 mg. It should be noted that nebivolol was added to the subject's existing stable antihypertensive regimen which included a mean of 2 other medications.

Study groups in NCT01056718
Study group	Role	What they receive
Nebivolol treatment	Other	10 week open label nebivolol treatment. Receives: Drug: Nebivolol

What is being measured

The primary outcome is the main question the study is designed to answer.

Resting Systolic BP
Measured: 10 Weeks
Exercise Duration
Measured: 10 Weeks
Metabolic Equivalent (METS) Level
METs is a measure of exercise capacity. One MET is defined as 3.5 mL 02 uptake/kg per minute which is the resting oxygen uptake in a sitting position. The Bruce protocol consisted of successive 3 minute stages each of which requires the subject to walk at a faster speed and higher grade of incline. Each stage is assigned a MET level. The achieved exercise capacity in METs has been shown to be predictive in older adult population of survival with higher MET levels associated with improved survival.
Measured: 10 Weeks

Secondary outcomes (24)

Diastolic BP
Measured: 10 Week
Peak Stress Systolic BP
Measured: 10 Week
Peak Stress Diastolic BP
Measured: 10 Week
Resting Heart Rate
Measured: 10 Week
Stress Heart Rate
Measured: 10 Week
Resting EF
Measured: 10 Weeks
Stress EF
Measured: 10 Week
Resting Stroke Volume
Measured: 10 weeks
Stress Stroke Volume
Measured: 10 week
Resting Cardiac Output
Measured: 10 week
Stress Cardiac Output
Measured: 10 week
LV End Diastolic Diameter
Measured: 10 week
LV End Systolic Diameter
Measured: 10 week
LV Mass
Measured: 10 week
Mitral Valve Inflow (E) Velocity
Measured: 10 Week
Mitral Valve Inflow (A) Velocity
Measured: 10 Week
Mitral Valve E/A Ratio
mitral valve doppler E velocity to A velocity
Measured: 10 Week
Mitral Valve Deceleration Time
Measured: 10 Week
Mitral Valve Tissue Doppler Velocity (e')
Measured: 10 Week
Mitral Valve Tissue Doppler Velocity (a')
Measured: 10 Week
E/e' Ratio
Measured: 10 Week
Pulmonary Vein Peak Systolic Velocity
Measured: 10 Week
Pulmonary Vein Peak Diastolic Velocity
Measured: 10 Week
Quality of Life
Quality of life was assessed by a visual analogue scale before and after 10 weeks of nebivolol. The subjects self reported assessment of his/her overall health was recorded on a vertical visual analogue scale where 100 is the "best imaginable health state" and 0 is the "worst imaginable health state".
Measured: 10 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2009May 2014

First posted26 Jan 2010 (estimated)
Study startNov 2009
Primary completionNov 2013
Study completionMay 2014

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.
Publications (1)Papers the sponsor has linked to this study.
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 N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 53 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01056718
Sponsor's protocol ID: BYS-MD-32
Status last verified: Mar 2017
First submitted: 25 Jan 2010
Last updated: 18 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.
PubMed 10109801

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Nebivolol on Exercise Tolerance and Left Ventricular Systolic and Diastolic Function
ClinicalTrials.gov ID: NCT01056718
Acronym / sponsor ID: BYS-MD-32
Conditions: Hypertension
Keywords: Diastolic Function, Nebivolol
Study type: Interventional
Recruitment status: Completed
Enrolment: 53 participants (actual)
Lead sponsor: Mercy ResearchUniversity, hospital or other
Collaborators: Forest Laboratories
Study start: Nov 2009
Primary completion: Nov 2013 (actual)
Study completion: May 2014 (actual)
First posted: 26 Jan 2010 (estimated)
Results: Posted 21 Mar 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Nebivolol treatment	Other	Drug: Nebivolol10 week open label nebivolol treatment.

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Diagnosis (new or established) hypertension, defined by serial measurements >/= 140/90
Evidence of diastolic dysfunction on echocardiography measured by tissue Doppler

Key exclusion criteria (8 listed)

Severe bronchospastic disease/ reactive airway disease
Inability to tolerate beta blocker therapy including: >1st degree atrioventricular (AV) block, symptomatic hypotension, symptomatic bradycardia,
Subjects with physical limitations that would prevent them from participating in an exercise treadmill test
Age <18 or >90 years
Those with life expectancy <1 year

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
NebivololInitial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure. The dose was titrated by doubling the previous dosage to achieve BP less than or equal to 130/80 mm Hg at 2 weeks and 4 weeks. The mean dose of nebivolol used week 4 through week 10 was 7.8 mg. It should be noted that nebivolol was added to the subject's existing stable antihypertensive regimen which included a mean of 2 other medications.	Drug	Nebivolol treatment

Primary outcome

Resting Systolic BP
Time frame: 10 Weeks
Exercise Duration
Time frame: 10 Weeks
Metabolic Equivalent (METS) Level
Time frame: 10 Weeks
METs is a measure of exercise capacity. One MET is defined as 3.5 mL 02 uptake/kg per minute which is the resting oxygen uptake in a sitting position. The Bruce protocol consisted of successive 3 minute stages each of which requires the subject to walk at a faster speed and higher grade of incline. Each stage is assigned a MET level. The achieved exercise capacity in METs has been shown to be predictive in older adult population of survival with higher MET levels associated with improved survival.

24 secondary outcomes

Diastolic BP
Time frame: 10 Week
Peak Stress Systolic BP
Time frame: 10 Week
Peak Stress Diastolic BP
Time frame: 10 Week
Resting Heart Rate
Time frame: 10 Week
Stress Heart Rate
Time frame: 10 Week
Resting EF
Time frame: 10 Weeks
Stress EF
Time frame: 10 Week
Resting Stroke Volume
Time frame: 10 weeks
Stress Stroke Volume
Time frame: 10 week
Resting Cardiac Output
Time frame: 10 week
Stress Cardiac Output
Time frame: 10 week
LV End Diastolic Diameter
Time frame: 10 week
LV End Systolic Diameter
Time frame: 10 week
LV Mass
Time frame: 10 week
Mitral Valve Inflow (E) Velocity
Time frame: 10 Week
Mitral Valve Inflow (A) Velocity
Time frame: 10 Week
Mitral Valve E/A Ratio
Time frame: 10 Week
Mitral Valve Deceleration Time
Time frame: 10 Week
Mitral Valve Tissue Doppler Velocity (e')
Time frame: 10 Week
Mitral Valve Tissue Doppler Velocity (a')
Time frame: 10 Week
E/e' Ratio
Time frame: 10 Week
Pulmonary Vein Peak Systolic Velocity
Time frame: 10 Week
Pulmonary Vein Peak Diastolic Velocity
Time frame: 10 Week
Quality of Life
Time frame: 10 Weeks

Results and safety

Results posted to the registry on 21 Mar 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Nebivolol Treatment	53	50

Primary outcome: Resting Systolic BP

Time frame: 10 Weeks. Mean (Standard Deviation). Unit: mm Hg

Measure	Nebivolol Treatment n = 50
Value	135 (17)

Nebivolol Treatment: p <0.05, t-test, 2 sided

Primary outcome: Exercise Duration

Time frame: 10 Weeks. Mean (Standard Deviation). Unit: Seconds

Measure	Nebivolol Treatment n = 50
Value	419 (180)

Nebivolol Treatment: p <0.05, t-test, 2 sided

Primary outcome: Metabolic Equivalent (METS) Level

Time frame: 10 Weeks. Mean (Standard Deviation). Unit: METS

Measure	Nebivolol Treatment n = 50
Value	6.7 (3.2)

Nebivolol Treatment: p <0.05, t-test, 2 sided

24 secondary outcomes are reported in the full results.

Adverse events

Time frame: Patients were monitored for 10 weeks for any adverse side effects resulting in discontinuation or decrease in nebivolol dosage after the titration period. They were also monitored for cardiovascular events during the treatment period.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Starting on 5 mg of Nebivolol Then Titrated	0 of 50 (0%)	0 of 50 (0%)	Not reported

Limitations and caveats (from the sponsor): There was no placebo control. All patients received nebivolol and served as their own control before and after treatment. This study had a small study population and short duration.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 10109801EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.
Individual participant dataSharing planned: No

Related trials for Hypertension

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Recruiting
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Recruiting
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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.

James A. Stokes, M.D. principal investigator

St. John's Mercy Heart & Vascular

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Nebivolol in people with Hypertension, run by Mercy Research at 1 site in United States.

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 2 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 18 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 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?

Resting Systolic BP (time frame: 10 Weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01056718, which also lists 1 linked publication.

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 18 Apr 2017.