Trial Outcomes & Findings for Effects of Nebivolol on Exercise Tolerance and Left Ventricular Systolic and Diastolic Function (NCT NCT01056718)

NCT ID: NCT01056718

Last Updated: 2017-04-18

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 53 participants
• Primary outcome timeframe: 10 Weeks
• Results posted on: 2017-04-18

Participant Flow

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.

Participant milestones

Measure	Nebivolol Treatment 10 week open label nebivolol treatment.
Overall Study STARTED	53
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Nebivolol Treatment 10 week open label nebivolol treatment.
Overall Study Withdrawal by Subject	2
Overall Study Ischemia on baseline stress test	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Nebivolol Treatment n=53 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants
Age, Categorical >=65 years	33 Participants n=5 Participants
Age, Continuous	66 Years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants
Region of Enrollment United States	53 participants n=5 Participants
BMI	31 kg/m2 STANDARD_DEVIATION 5 • n=5 Participants
Resting Systolic BP	145 mm Hg STANDARD_DEVIATION 19 • n=5 Participants
Exercise Duration	385 seconds STANDARD_DEVIATION 174 • n=5 Participants
Metabolic Equivalent	6.2 Mets STANDARD_DEVIATION 3.1 • n=5 Participants
Resting Diastolic BP	79 mm Hg STANDARD_DEVIATION 11 • n=5 Participants
Peak Stress Systolic BP	178 mm Hg STANDARD_DEVIATION 23 • n=5 Participants
Peak Stress Diastolic BP	75 mm Hg STANDARD_DEVIATION 15 • n=5 Participants
Resting Heart Rate	69 Beats per Minute STANDARD_DEVIATION 11 • n=5 Participants
Stress Heart Rate	136 Beats per Minute STANDARD_DEVIATION 24 • n=5 Participants
Resting Ejection Fraction (EF)	61 Percent of LV end diastolic volume STANDARD_DEVIATION 10 • n=5 Participants
Stress EF	67 Percent of LV end diastolic volume STANDARD_DEVIATION 10 • n=5 Participants
Resting Stroke Volume	46 ml STANDARD_DEVIATION 15 • n=5 Participants
Stress Stroke Volume	47 ml STANDARD_DEVIATION 13 • n=5 Participants
Resting Cardiac Output	3.1 L per minute STANDARD_DEVIATION 1.1 • n=5 Participants
Stress Cardiac Output	5.6 L per minute STANDARD_DEVIATION 2.2 • n=5 Participants
LV End Diastolic Diameter	4.7 cm STANDARD_DEVIATION 0.5 • n=5 Participants
LV End Systolic Diameter	3.0 cm STANDARD_DEVIATION 0.8 • n=5 Participants
LV Mass	163 grams STANDARD_DEVIATION 52 • n=5 Participants
Mitral Valve Inflow (E) Velocity	77 cm/s STANDARD_DEVIATION 24 • n=5 Participants
Mitral Valve Inflow (A) Velocity	91 cm/s STANDARD_DEVIATION 21 • n=5 Participants
Mitral Valve E/A Ratio	.86 Ratio STANDARD_DEVIATION .18 • n=5 Participants
Mitral Valve Deceleration Time	229 ms STANDARD_DEVIATION 62 • n=5 Participants
Mitral Valve Tissue Doppler Velocity (e')	7.6 cm/s STANDARD_DEVIATION 1.9 • n=5 Participants
Mitral Valve Tissue Doppler Velocity (a')	11.8 cm/s STANDARD_DEVIATION 2.9 • n=5 Participants
E/e' Ratio	10.8 Ratio STANDARD_DEVIATION 4.7 • n=5 Participants
Pulmonary Vein Peak Systolic Velocity	62 cm/s STANDARD_DEVIATION 13 • n=5 Participants
Pulmonary Vein Peak Diastolic Velocity	47 cm/s STANDARD_DEVIATION 13 • n=5 Participants
Quality of Life	77 units on a scale STANDARD_DEVIATION 12 • n=5 Participants

PRIMARY outcome

Timeframe: 10 Weeks

Outcome measures

Measure	Nebivolol Treatment n=50 Participants 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.
Resting Systolic BP	135 mm Hg Standard Deviation 17

PRIMARY outcome

Timeframe: 10 Weeks

Outcome measures

Measure	Nebivolol Treatment n=50 Participants 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.
Exercise Duration	419 Seconds Standard Deviation 180

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Nebivolol Treatment n=50 Participants 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.
Metabolic Equivalent (METS) Level	6.7 METS Standard Deviation 3.2

SECONDARY outcome

Timeframe: 10 Week

Outcome measures

Measure	Nebivolol Treatment n=50 Participants 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.
Diastolic BP	76 mm Hg Standard Deviation 9

SECONDARY outcome

Timeframe: 10 Week

Outcome measures

Measure	Nebivolol Treatment n=50 Participants 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.
Peak Stress Systolic BP	171 mm Hg Standard Deviation 26

SECONDARY outcome

Timeframe: 10 Week

Outcome measures

Measure	Nebivolol Treatment n=50 Participants 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.
Peak Stress Diastolic BP	68 mm Hg Standard Deviation 17

SECONDARY outcome

Timeframe: 10 Week

Outcome measures

Measure	Nebivolol Treatment n=50 Participants 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.
Resting Heart Rate	65 Beats per Minute Standard Deviation 9

SECONDARY outcome

Timeframe: 10 Week

Outcome measures

Measure	Nebivolol Treatment n=50 Participants 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.
Stress Heart Rate	118 Beats per Minute Standard Deviation 24

SECONDARY outcome

Timeframe: 10 Weeks

Outcome measures

Measure	Nebivolol Treatment n=50 Participants 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.
Resting EF	63 Percent of LV end diastolic volume Standard Deviation 9

SECONDARY outcome

Timeframe: 10 Week

Outcome measures

Measure	Nebivolol Treatment n=50 Participants 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.
Stress EF	72 Percent of LV end diastolic volume Standard Deviation 10

SECONDARY outcome

Timeframe: 10 weeks

Outcome measures

Measure	Nebivolol Treatment n=50 Participants 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.
Resting Stroke Volume	48 ml Standard Deviation 14

SECONDARY outcome

Timeframe: 10 week

Outcome measures

Measure	Nebivolol Treatment n=50 Participants 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.
Stress Stroke Volume	51 ml Standard Deviation 16

SECONDARY outcome

Timeframe: 10 week

Outcome measures

Measure	Nebivolol Treatment n=50 Participants 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.
Resting Cardiac Output	3.0 L per minute Standard Deviation 0.9

SECONDARY outcome

Timeframe: 10 week

Outcome measures

Measure	Nebivolol Treatment n=50 Participants 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.
Stress Cardiac Output	5.3 L per minute Standard Deviation 1.7

SECONDARY outcome

Timeframe: 10 week

Outcome measures

Measure	Nebivolol Treatment n=50 Participants 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.
LV End Diastolic Diameter	4.8 cm Standard Deviation 0.6

SECONDARY outcome

Timeframe: 10 week

Outcome measures

Measure	Nebivolol Treatment n=50 Participants 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.
LV End Systolic Diameter	3.1 cm Standard Deviation 0.7

SECONDARY outcome

Timeframe: 10 week

Outcome measures

Measure	Nebivolol Treatment n=50 Participants 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.
LV Mass	167 grams Standard Deviation 47

SECONDARY outcome

Timeframe: 10 Week

Outcome measures

Measure	Nebivolol Treatment n=50 Participants 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.
Mitral Valve Inflow (E) Velocity	85 cm/s Standard Deviation 21

SECONDARY outcome

Timeframe: 10 Week

Outcome measures

Measure	Nebivolol Treatment n=50 Participants 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.
Mitral Valve Inflow (A) Velocity	90 cm/s Standard Deviation 23

SECONDARY outcome

Timeframe: 10 Week

mitral valve doppler E velocity to A velocity

Outcome measures

Measure	Nebivolol Treatment n=50 Participants 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.
Mitral Valve E/A Ratio	0.97 Ratio Standard Deviation 0.31

SECONDARY outcome

Timeframe: 10 Week

Outcome measures

Measure	Nebivolol Treatment n=50 Participants 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.
Mitral Valve Deceleration Time	227 ms Standard Deviation 55

SECONDARY outcome

Timeframe: 10 Week

Outcome measures

Measure	Nebivolol Treatment n=50 Participants 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.
Mitral Valve Tissue Doppler Velocity (e')	8.7 cm/s Standard Deviation 2.6

SECONDARY outcome

Timeframe: 10 Week

Outcome measures

Measure	Nebivolol Treatment n=50 Participants 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.
Mitral Valve Tissue Doppler Velocity (a')	11.5 cm/s Standard Deviation 2.9

SECONDARY outcome

Timeframe: 10 Week

Outcome measures

Measure	Nebivolol Treatment n=50 Participants 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.
E/e' Ratio	10.5 Ratio Standard Deviation 4.4

SECONDARY outcome

Timeframe: 10 Week

Outcome measures

Measure	Nebivolol Treatment n=50 Participants 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.
Pulmonary Vein Peak Systolic Velocity	63 cm/s Standard Deviation 10

SECONDARY outcome

Timeframe: 10 Week

Outcome measures

Measure	Nebivolol Treatment n=50 Participants 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.
Pulmonary Vein Peak Diastolic Velocity	51 cm/s Standard Deviation 16

SECONDARY outcome

Timeframe: 10 Weeks

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".

Outcome measures

Measure	Nebivolol Treatment n=50 Participants 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.
Quality of Life	78 units on a scale Standard Deviation 15

Adverse Events

Starting on 5 mg of Nebivolol Then Titrated

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

Denise Janosik, MD

Mercy Hospital East Communities

Phone: 314-251-3920

Email: Denise.Janosik@mercy.net

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place