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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypertension | Drug: Nebivolol | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 53 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Effects of Nebivolol on Exercise Tolerance and Left Ventricular Systolic and Diastolic Function |
Study Start Date : | November 2009 |
Actual Primary Completion Date : | November 2013 |
Actual Study Completion Date : | May 2014 |

Arm | Intervention/treatment |
---|---|
Nebivolol treatment
10 week open label nebivolol treatment.
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Drug: Nebivolol
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. |
- 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.
- 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 doppler E velocity to A velocity
- 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 ]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".

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Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01056718
United States, Missouri | |
St. John's Mercy Cardiovascular Research | |
St. Louis, Missouri, United States, 63141 |
Principal Investigator: | James A. Stokes, M.D. | St. John's Mercy Heart & Vascular |
Responsible Party: | James Stokes, MD, Cardiologist Mercy Hospital, Mercy Research |
ClinicalTrials.gov Identifier: | NCT01056718 |
Other Study ID Numbers: |
BYS-MD-32 |
First Posted: | January 26, 2010 Key Record Dates |
Results First Posted: | March 21, 2016 |
Last Update Posted: | April 18, 2017 |
Last Verified: | March 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Diastolic Function Nebivolol |
Hypertension Vascular Diseases Cardiovascular Diseases Nebivolol Antihypertensive Agents Vasodilator Agents Adrenergic beta-1 Receptor Agonists |
Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |