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Completed

NCT Number: NCT01056718

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

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. John's Mercy Cardiovascular Research

St Louis, Missouri, 63141, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

nebivolol

Drug

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.

Primary outcomes

  1. Resting Systolic BP

    Time frame: 10 Weeks

  2. Exercise Duration

    Time frame: 10 Weeks

  3. 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.

Secondary outcomes

  1. Diastolic BP

    Time frame: 10 Week

  2. Peak Stress Systolic BP

    Time frame: 10 Week

  3. Peak Stress Diastolic BP

    Time frame: 10 Week

  4. Resting Heart Rate

    Time frame: 10 Week

  5. Stress Heart Rate

    Time frame: 10 Week

  6. Resting EF

    Time frame: 10 Weeks

  7. Stress EF

    Time frame: 10 Week

  8. Resting Stroke Volume

    Time frame: 10 weeks

  9. Stress Stroke Volume

    Time frame: 10 week

  10. Resting Cardiac Output

    Time frame: 10 week

  11. Stress Cardiac Output

    Time frame: 10 week

  12. LV End Diastolic Diameter

    Time frame: 10 week

  13. LV End Systolic Diameter

    Time frame: 10 week

  14. LV Mass

    Time frame: 10 week

  15. Mitral Valve Inflow (E) Velocity

    Time frame: 10 Week

  16. Mitral Valve Inflow (A) Velocity

    Time frame: 10 Week

  17. Mitral Valve E/A Ratio

    Time frame: 10 Week

    mitral valve doppler E velocity to A velocity

  18. Mitral Valve Deceleration Time

    Time frame: 10 Week

  19. Mitral Valve Tissue Doppler Velocity (e')

    Time frame: 10 Week

  20. Mitral Valve Tissue Doppler Velocity (a')

    Time frame: 10 Week

  21. E/e' Ratio

    Time frame: 10 Week

  22. Pulmonary Vein Peak Systolic Velocity

    Time frame: 10 Week

  23. Pulmonary Vein Peak Diastolic Velocity

    Time frame: 10 Week

  24. Quality of Life

    Time frame: 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".

Sponsors and collaborators

Lead sponsor

Mercy Research

Other

Collaborators

  • Forest Laboratories

Registry information

Important dates

Study start
2009
Primary completion
2013
Study completion
2014
First posted
Jan 26, 2010
Registry last updated
Apr 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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