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Trial record 1 of 39 for:    10109801 [PUBMED-IDS]
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Effects of Nebivolol on Exercise Tolerance and Left Ventricular Systolic and Diastolic Function

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ClinicalTrials.gov Identifier: NCT01056718
Recruitment Status : Completed
First Posted : January 26, 2010
Results First Posted : March 21, 2016
Last Update Posted : April 18, 2017
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
James Stokes, MD, Mercy Research

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hypertension
Intervention Drug: Nebivolol
Enrollment 53
Recruitment Details Recruited from the outpatient office at Mercy St. Louis between January 2010 and August 2012. The inclusion criteria were new or established hypertension as defined by serial BP measurements greater than or equal to 140/90 and evidence of left ventricular (LV) diastolic dysfunction as defined by a routine Doppler within a year of enrollment.
Pre-assignment Details  
Arm/Group Title Nebivolol Treatment
Hide Arm/Group Description 10 week open label nebivolol treatment.
Period Title: Overall Study
Started 53
Completed 50
Not Completed 3
Reason Not Completed
Withdrawal by Subject             2
Ischemia on baseline stress test             1
Arm/Group Title Nebivolol Treatment
Hide Arm/Group Description

All subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.

Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure.

Overall Number of Baseline Participants 53
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants
<=18 years
0
   0.0%
Between 18 and 65 years
20
  37.7%
>=65 years
33
  62.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 53 participants
66  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants
Female
20
  37.7%
Male
33
  62.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 53 participants
53
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 53 participants
31  (5)
Resting Systolic BP  
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Number Analyzed 53 participants
145  (19)
Exercise Duration  
Mean (Standard Deviation)
Unit of measure:  Seconds
Number Analyzed 53 participants
385  (174)
Metabolic Equivalent   [1] 
Mean (Standard Deviation)
Unit of measure:  Mets
Number Analyzed 53 participants
6.2  (3.1)
[1]
Measure Description: One MET is defined as 3.5 mL 02 uptake/kg per minute
Resting Diastolic BP  
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Number Analyzed 53 participants
79  (11)
Peak Stress Systolic BP  
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Number Analyzed 53 participants
178  (23)
Peak Stress Diastolic BP  
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Number Analyzed 53 participants
75  (15)
Resting Heart Rate  
Mean (Standard Deviation)
Unit of measure:  Beats per Minute
Number Analyzed 53 participants
69  (11)
Stress Heart Rate  
Mean (Standard Deviation)
Unit of measure:  Beats per Minute
Number Analyzed 53 participants
136  (24)
Resting Ejection Fraction (EF)   [1] 
Mean (Standard Deviation)
Unit of measure:  Percent of LV end diastolic volume
Number Analyzed 53 participants
61  (10)
[1]
Measure Description: Ejection fraction = LV end diastolic volume - LV end systolic volume divided by LV end diastolic volume X 100
Stress EF  
Mean (Standard Deviation)
Unit of measure:  Percent of LV end diastolic volume
Number Analyzed 53 participants
67  (10)
Resting Stroke Volume  
Mean (Standard Deviation)
Unit of measure:  Ml
Number Analyzed 53 participants
46  (15)
Stress Stroke Volume  
Mean (Standard Deviation)
Unit of measure:  Ml
Number Analyzed 53 participants
47  (13)
Resting Cardiac Output  
Mean (Standard Deviation)
Unit of measure:  L per minute
Number Analyzed 53 participants
3.1  (1.1)
Stress Cardiac Output  
Mean (Standard Deviation)
Unit of measure:  L per minute
Number Analyzed 53 participants
5.6  (2.2)
LV End Diastolic Diameter  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 53 participants
4.7  (0.5)
LV End Systolic Diameter  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 53 participants
3.0  (0.8)
LV Mass  
Mean (Standard Deviation)
Unit of measure:  Grams
Number Analyzed 53 participants
163  (52)
Mitral Valve Inflow (E) Velocity  
Mean (Standard Deviation)
Unit of measure:  Cm/s
Number Analyzed 53 participants
77  (24)
Mitral Valve Inflow (A) Velocity  
Mean (Standard Deviation)
Unit of measure:  Cm/s
Number Analyzed 53 participants
91  (21)
Mitral Valve E/A Ratio   [1] 
Mean (Standard Deviation)
Unit of measure:  Ratio
Number Analyzed 53 participants
.86  (.18)
[1]
Measure Description: Mitral valve doppler E velocity to A velocity
Mitral Valve Deceleration Time  
Mean (Standard Deviation)
Unit of measure:  Ms
Number Analyzed 53 participants
229  (62)
Mitral Valve Tissue Doppler Velocity (e')  
Mean (Standard Deviation)
Unit of measure:  Cm/s
Number Analyzed 53 participants
7.6  (1.9)
Mitral Valve Tissue Doppler Velocity (a')  
Mean (Standard Deviation)
Unit of measure:  Cm/s
Number Analyzed 53 participants
11.8  (2.9)
E/e' Ratio   [1] 
Mean (Standard Deviation)
Unit of measure:  Ratio
Number Analyzed 53 participants
10.8  (4.7)
[1]
Measure Description: Mitral Valve E velocity to tissue doppler e' velocity
Pulmonary Vein Peak Systolic Velocity  
Mean (Standard Deviation)
Unit of measure:  Cm/s
Number Analyzed 53 participants
62  (13)
Pulmonary Vein Peak Diastolic Velocity  
Mean (Standard Deviation)
Unit of measure:  Cm/s
Number Analyzed 53 participants
47  (13)
Quality of Life   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 53 participants
77  (12)
[1]
Measure Description: 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. The EuroQol, records the subject's self reported assessment of his/her overall health on a vertical, visual analogue scale where 100 is "the best imaginable health state" and 0 is the "worst imaginable health state".
1.Primary Outcome
Title Resting Systolic BP
Hide Description [Not Specified]
Time Frame 10 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nebivolol Treatment
Hide Arm/Group Description:

all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.

Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure.

Overall Number of Participants Analyzed 50
Mean (Standard Deviation)
Unit of Measure: mm Hg
135  (17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nebivolol Treatment
Comments Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of treatment. Each subject served as his/her own control.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Primary Outcome
Title Exercise Duration
Hide Description [Not Specified]
Time Frame 10 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nebivolol Treatment
Hide Arm/Group Description:

all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.

Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure.

Overall Number of Participants Analyzed 50
Mean (Standard Deviation)
Unit of Measure: Seconds
419  (180)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nebivolol Treatment
Comments Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Primary Outcome
Title Metabolic Equivalent (METS) Level
Hide Description 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.
Time Frame 10 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nebivolol Treatment
Hide Arm/Group Description:

all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.

Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure.

Overall Number of Participants Analyzed 50
Mean (Standard Deviation)
Unit of Measure: METS
6.7  (3.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nebivolol Treatment
Comments Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title Diastolic BP
Hide Description [Not Specified]
Time Frame 10 Week
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nebivolol Treatment
Hide Arm/Group Description:

all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.

Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure.

Overall Number of Participants Analyzed 50
Mean (Standard Deviation)
Unit of Measure: mm Hg
76  (9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nebivolol Treatment
Comments Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =.078
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
5.Secondary Outcome
Title Peak Stress Systolic BP
Hide Description [Not Specified]
Time Frame 10 Week
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nebivolol Treatment
Hide Arm/Group Description:

all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.

Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure.

Overall Number of Participants Analyzed 50
Mean (Standard Deviation)
Unit of Measure: mm Hg
171  (26)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nebivolol Treatment
Comments Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =.186
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
6.Secondary Outcome
Title Peak Stress Diastolic BP
Hide Description [Not Specified]
Time Frame 10 Week
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nebivolol Treatment
Hide Arm/Group Description:

all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.

Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure.

Overall Number of Participants Analyzed 50
Mean (Standard Deviation)
Unit of Measure: mm Hg
68  (17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nebivolol Treatment
Comments Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
7.Secondary Outcome
Title Resting Heart Rate
Hide Description [Not Specified]
Time Frame 10 Week
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nebivolol Treatment
Hide Arm/Group Description:

All subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.

Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure.

Overall Number of Participants Analyzed 50
Mean (Standard Deviation)
Unit of Measure: Beats per Minute
65  (9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nebivolol Treatment
Comments Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
8.Secondary Outcome
Title Stress Heart Rate
Hide Description [Not Specified]
Time Frame 10 Week
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nebivolol Treatment
Hide Arm/Group Description:

All subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.

Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure.

Overall Number of Participants Analyzed 50
Mean (Standard Deviation)
Unit of Measure: Beats per Minute
118  (24)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nebivolol Treatment
Comments Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.06
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
9.Secondary Outcome
Title Resting EF
Hide Description [Not Specified]
Time Frame 10 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nebivolol Treatment
Hide Arm/Group Description:

All subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.

Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure.

Overall Number of Participants Analyzed 50
Mean (Standard Deviation)
Unit of Measure: Percent of LV end diastolic volume
63  (9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nebivolol Treatment
Comments Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
10.Secondary Outcome
Title Stress EF
Hide Description [Not Specified]
Time Frame 10 Week
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nebivolol Treatment
Hide Arm/Group Description:

all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.

Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure.

Overall Number of Participants Analyzed 50
Mean (Standard Deviation)
Unit of Measure: Percent of LV end diastolic volume
72  (10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nebivolol Treatment
Comments Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
11.Secondary Outcome
Title Resting Stroke Volume
Hide Description [Not Specified]
Time Frame 10 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nebivolol Treatment
Hide Arm/Group Description:

all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.

Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure.

Overall Number of Participants Analyzed 50
Mean (Standard Deviation)
Unit of Measure: ml
48  (14)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nebivolol Treatment
Comments Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.85
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
12.Secondary Outcome
Title Stress Stroke Volume
Hide Description [Not Specified]
Time Frame 10 week
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nebivolol Treatment
Hide Arm/Group Description:

all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.

Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure.

Overall Number of Participants Analyzed 50
Mean (Standard Deviation)
Unit of Measure: ml
51  (16)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nebivolol Treatment
Comments Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.40
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
13.Secondary Outcome
Title Resting Cardiac Output
Hide Description [Not Specified]
Time Frame 10 week
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nebivolol Treatment
Hide Arm/Group Description:

all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.

Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure.

Overall Number of Participants Analyzed 50
Mean (Standard Deviation)
Unit of Measure: L per minute
3.0  (0.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nebivolol Treatment
Comments Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.64
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
14.Secondary Outcome
Title Stress Cardiac Output
Hide Description [Not Specified]
Time Frame 10 week
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nebivolol Treatment
Hide Arm/Group Description:

all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.

Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure.

Overall Number of Participants Analyzed 50
Mean (Standard Deviation)
Unit of Measure: L per minute
5.3  (1.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nebivolol Treatment
Comments Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.49
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
15.Secondary Outcome
Title LV End Diastolic Diameter
Hide Description [Not Specified]
Time Frame 10 week
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nebivolol Treatment
Hide Arm/Group Description:

all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.

Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure.

Overall Number of Participants Analyzed 50
Mean (Standard Deviation)
Unit of Measure: cm
4.8  (0.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nebivolol Treatment
Comments Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.47
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
16.Secondary Outcome
Title LV End Systolic Diameter
Hide Description [Not Specified]
Time Frame 10 week
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nebivolol Treatment
Hide Arm/Group Description:

all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.

Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure.

Overall Number of Participants Analyzed 50
Mean (Standard Deviation)
Unit of Measure: cm
3.1  (0.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nebivolol Treatment
Comments Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.55
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
17.Secondary Outcome
Title LV Mass
Hide Description [Not Specified]
Time Frame 10 week
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nebivolol Treatment
Hide Arm/Group Description:

all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.

Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure.

Overall Number of Participants Analyzed 50
Mean (Standard Deviation)
Unit of Measure: grams
167  (47)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nebivolol Treatment
Comments Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.64
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
18.Secondary Outcome
Title Mitral Valve Inflow (E) Velocity
Hide Description [Not Specified]
Time Frame 10 Week
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nebivolol Treatment
Hide Arm/Group Description:

all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.

Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure.

Overall Number of Participants Analyzed 50
Mean (Standard Deviation)
Unit of Measure: cm/s
85  (21)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nebivolol Treatment
Comments Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
19.Secondary Outcome
Title Mitral Valve Inflow (A) Velocity
Hide Description [Not Specified]
Time Frame 10 Week
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nebivolol Treatment
Hide Arm/Group Description:

all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.

Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure.

Overall Number of Participants Analyzed 50
Mean (Standard Deviation)
Unit of Measure: cm/s
90  (23)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nebivolol Treatment
Comments Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =.526
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
20.Secondary Outcome
Title Mitral Valve E/A Ratio
Hide Description mitral valve doppler E velocity to A velocity
Time Frame 10 Week
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nebivolol Treatment
Hide Arm/Group Description:

all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.

Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure.

Overall Number of Participants Analyzed 50
Mean (Standard Deviation)
Unit of Measure: Ratio
0.97  (0.31)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nebivolol Treatment
Comments Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
21.Secondary Outcome
Title Mitral Valve Deceleration Time
Hide Description [Not Specified]
Time Frame 10 Week
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nebivolol Treatment
Hide Arm/Group Description:

all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.

Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure.

Overall Number of Participants Analyzed 50
Mean (Standard Deviation)
Unit of Measure: ms
227  (55)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nebivolol Treatment
Comments Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =.925
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
22.Secondary Outcome
Title Mitral Valve Tissue Doppler Velocity (e')
Hide Description [Not Specified]
Time Frame 10 Week
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nebivolol Treatment
Hide Arm/Group Description:

all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.

Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure.

Overall Number of Participants Analyzed 50
Mean (Standard Deviation)
Unit of Measure: cm/s
8.7  (2.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nebivolol Treatment
Comments Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
23.Secondary Outcome
Title Mitral Valve Tissue Doppler Velocity (a')
Hide Description [Not Specified]
Time Frame 10 Week
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nebivolol Treatment
Hide Arm/Group Description:

all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.

Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure.

Overall Number of Participants Analyzed 50
Mean (Standard Deviation)
Unit of Measure: cm/s
11.5  (2.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nebivolol Treatment
Comments Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =.458
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
24.Secondary Outcome
Title E/e' Ratio
Hide Description [Not Specified]
Time Frame 10 Week
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nebivolol Treatment
Hide Arm/Group Description:

all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.

Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure.

Overall Number of Participants Analyzed 50
Mean (Standard Deviation)
Unit of Measure: Ratio
10.5  (4.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nebivolol Treatment
Comments Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =.561
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
25.Secondary Outcome
Title Pulmonary Vein Peak Systolic Velocity
Hide Description [Not Specified]
Time Frame 10 Week
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nebivolol Treatment
Hide Arm/Group Description:

all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.

Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure.

Overall Number of Participants Analyzed 50
Mean (Standard Deviation)
Unit of Measure: cm/s
63  (10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nebivolol Treatment
Comments Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =.734
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
26.Secondary Outcome
Title Pulmonary Vein Peak Diastolic Velocity
Hide Description [Not Specified]
Time Frame 10 Week
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nebivolol Treatment
Hide Arm/Group Description:

all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.

Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure.

Overall Number of Participants Analyzed 50
Mean (Standard Deviation)
Unit of Measure: cm/s
51  (16)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nebivolol Treatment
Comments Nebivolol treatment group refers to 50 patients that completed 10 weeks of open label nebivolol treatment. Results were compared using paired T-tests in a pre - post study design before and after 10 weeks of his/her treatment. Each subject served as own control.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =.129
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
27.Secondary Outcome
Title Quality of Life
Hide Description 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".
Time Frame 10 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nebivolol Treatment
Hide Arm/Group Description:

all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.

Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure.

Overall Number of Participants Analyzed 50
Mean (Standard Deviation)
Unit of Measure: units on a scale
78  (15)
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.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Starting on 5 mg of Nebivolol Then Titrated
Hide Arm/Group Description

all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.

Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure.

All-Cause Mortality
Starting on 5 mg of Nebivolol Then Titrated
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Starting on 5 mg of Nebivolol Then Titrated
Affected / at Risk (%)
Total   0/50 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Starting on 5 mg of Nebivolol Then Titrated
Affected / at Risk (%)
Total   0/50 (0.00%) 
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Denise Janosik, MD
Organization: Mercy Hospital East Communities
Phone: 314-251-3920
Responsible Party: James Stokes, MD, Mercy Research
ClinicalTrials.gov Identifier: NCT01056718     History of Changes
Other Study ID Numbers: BYS-MD-32
First Submitted: January 25, 2010
First Posted: January 26, 2010
Results First Submitted: December 16, 2015
Results First Posted: March 21, 2016
Last Update Posted: April 18, 2017