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

NCT01056718 | Completed Results

• 1 other identifier: BYS-MD-32
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension

Keywords

Diastolic Function; Nebivolol

Outcome Measures

Primary Outcomes (3)

• Resting Systolic BP

  10 Weeks

• Exercise Duration

  10 Weeks

• Metabolic Equivalent (METS) Level

  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.

  10 Weeks

Secondary Outcomes (24)

• Diastolic BP

  10 Week

• Peak Stress Systolic BP

  10 Week

• Peak Stress Diastolic BP

  10 Week

• Resting Heart Rate

  10 Week

• Stress Heart Rate

  10 Week

Study Arms (1)

Nebivolol treatment

OTHER

10 week open label nebivolol treatment.

Drug: Nebivolol

Interventions

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.

Nebivolol treatment

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mercy Research: lead
• Forest Laboratories: collaborator

Study Sites (1)

St. John's Mercy Cardiovascular Research

St Louis, Missouri, 63141, United States

Location

Related Publications (1)

• EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.

  PMID: 10109801 RESULT

MeSH Terms

Conditions

Hypertension

Interventions

Nebivolol

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

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.

Results Point of Contact

• Title: Denise Janosik, MD
• Organization: Mercy Hospital East Communities

Denise.Janosik@mercy.net

314-251-3920

Study Officials

• James A. Stokes, M.D.

  St. John's Mercy Heart & Vascular

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiologist Mercy Hospital

Study Record Dates

• First Submitted: January 25, 2010
• First Posted: January 26, 2010
• Study Start: November 1, 2009
• Primary Completion: November 1, 2013
• Study Completion: May 1, 2014
• Last Updated: April 18, 2017
• Results First Posted: March 21, 2016

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)