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Trial record 1 of 32 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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Nebivolol Treatment 10 week open label nebivolol treatment.

Participant Flow:   Overall Study
    Nebivolol Treatment
STARTED   53 
COMPLETED   50 
NOT COMPLETED   3 
Withdrawal by Subject                2 
Ischemia on baseline stress test                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Nebivolol Treatment

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.


Baseline Measures
   Nebivolol Treatment 
Overall Participants Analyzed 
[Units: Participants]
 53 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      20  37.7% 
>=65 years      33  62.3% 
Age 
[Units: Years]
Mean (Standard Deviation)
 66  (10) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      20  37.7% 
Male      33  62.3% 
Region of Enrollment 
[Units: Participants]
 
United States   53 
BMI 
[Units: Kg/m2]
Mean (Standard Deviation)
 31  (5) 
Resting Systolic BP 
[Units: Mm Hg]
Mean (Standard Deviation)
 145  (19) 
Exercise Duration 
[Units: Seconds]
Mean (Standard Deviation)
 385  (174) 
Metabolic Equivalent [1] 
[Units: Mets]
Mean (Standard Deviation)
 6.2  (3.1) 
[1] One MET is defined as 3.5 mL 02 uptake/kg per minute
Resting Diastolic BP 
[Units: Mm Hg]
Mean (Standard Deviation)
 79  (11) 
Peak Stress Systolic BP 
[Units: Mm Hg]
Mean (Standard Deviation)
 178  (23) 
Peak Stress Diastolic BP 
[Units: Mm Hg]
Mean (Standard Deviation)
 75  (15) 
Resting Heart Rate 
[Units: Beats per Minute]
Mean (Standard Deviation)
 69  (11) 
Stress Heart Rate 
[Units: Beats per Minute]
Mean (Standard Deviation)
 136  (24) 
Resting Ejection Fraction (EF) [1] 
[Units: Percent of LV end diastolic volume]
Mean (Standard Deviation)
 61  (10) 
[1] Ejection fraction = LV end diastolic volume - LV end systolic volume divided by LV end diastolic volume X 100
Stress EF 
[Units: Percent of LV end diastolic volume]
Mean (Standard Deviation)
 67  (10) 
Resting Stroke Volume 
[Units: Ml]
Mean (Standard Deviation)
 46  (15) 
Stress Stroke Volume 
[Units: Ml]
Mean (Standard Deviation)
 47  (13) 
Resting Cardiac Output 
[Units: L per minute]
Mean (Standard Deviation)
 3.1  (1.1) 
Stress Cardiac Output 
[Units: L per minute]
Mean (Standard Deviation)
 5.6  (2.2) 
LV End Diastolic Diameter 
[Units: Cm]
Mean (Standard Deviation)
 4.7  (0.5) 
LV End Systolic Diameter 
[Units: Cm]
Mean (Standard Deviation)
 3.0  (0.8) 
LV Mass 
[Units: Grams]
Mean (Standard Deviation)
 163  (52) 
Mitral Valve Inflow (E) Velocity 
[Units: Cm/s]
Mean (Standard Deviation)
 77  (24) 
Mitral Valve Inflow (A) Velocity 
[Units: Cm/s]
Mean (Standard Deviation)
 91  (21) 
Mitral Valve E/A Ratio [1] 
[Units: Ratio]
Mean (Standard Deviation)
 .86  (.18) 
[1] Mitral valve doppler E velocity to A velocity
Mitral Valve Deceleration Time 
[Units: Ms]
Mean (Standard Deviation)
 229  (62) 
Mitral Valve Tissue Doppler Velocity (e') 
[Units: Cm/s]
Mean (Standard Deviation)
 7.6  (1.9) 
Mitral Valve Tissue Doppler Velocity (a') 
[Units: Cm/s]
Mean (Standard Deviation)
 11.8  (2.9) 
E/e' Ratio [1] 
[Units: Ratio]
Mean (Standard Deviation)
 10.8  (4.7) 
[1] Mitral Valve E velocity to tissue doppler e' velocity
Pulmonary Vein Peak Systolic Velocity 
[Units: Cm/s]
Mean (Standard Deviation)
 62  (13) 
Pulmonary Vein Peak Diastolic Velocity 
[Units: Cm/s]
Mean (Standard Deviation)
 47  (13) 
Quality of Life [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 77  (12) 
[1] 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".


  Outcome Measures

1.  Primary:   Resting Systolic BP   [ Time Frame: 10 Weeks ]

2.  Primary:   Exercise Duration   [ Time Frame: 10 Weeks ]

3.  Primary:   Metabolic Equivalent (METS) Level   [ Time Frame: 10 Weeks ]

4.  Secondary:   Diastolic BP   [ Time Frame: 10 Week ]

5.  Secondary:   Peak Stress Systolic BP   [ Time Frame: 10 Week ]

6.  Secondary:   Peak Stress Diastolic BP   [ Time Frame: 10 Week ]

7.  Secondary:   Resting Heart Rate   [ Time Frame: 10 Week ]

8.  Secondary:   Stress Heart Rate   [ Time Frame: 10 Week ]

9.  Secondary:   Resting EF   [ Time Frame: 10 Weeks ]

10.  Secondary:   Stress EF   [ Time Frame: 10 Week ]

11.  Secondary:   Resting Stroke Volume   [ Time Frame: 10 weeks ]

12.  Secondary:   Stress Stroke Volume   [ Time Frame: 10 week ]

13.  Secondary:   Resting Cardiac Output   [ Time Frame: 10 week ]

14.  Secondary:   Stress Cardiac Output   [ Time Frame: 10 week ]

15.  Secondary:   LV End Diastolic Diameter   [ Time Frame: 10 week ]

16.  Secondary:   LV End Systolic Diameter   [ Time Frame: 10 week ]

17.  Secondary:   LV Mass   [ Time Frame: 10 week ]

18.  Secondary:   Mitral Valve Inflow (E) Velocity   [ Time Frame: 10 Week ]

19.  Secondary:   Mitral Valve Inflow (A) Velocity   [ Time Frame: 10 Week ]

20.  Secondary:   Mitral Valve E/A Ratio   [ Time Frame: 10 Week ]

21.  Secondary:   Mitral Valve Deceleration Time   [ Time Frame: 10 Week ]

22.  Secondary:   Mitral Valve Tissue Doppler Velocity (e')   [ Time Frame: 10 Week ]

23.  Secondary:   Mitral Valve Tissue Doppler Velocity (a')   [ Time Frame: 10 Week ]

24.  Secondary:   E/e' Ratio   [ Time Frame: 10 Week ]

25.  Secondary:   Pulmonary Vein Peak Systolic Velocity   [ Time Frame: 10 Week ]

26.  Secondary:   Pulmonary Vein Peak Diastolic Velocity   [ Time Frame: 10 Week ]

27.  Secondary:   Quality of Life   [ Time Frame: 10 Weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information

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
e-mail: Denise.Janosik@mercy.net


Publications of Results:

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