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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
James Stokes, MD, St. John's Health System, Missouri
ClinicalTrials.gov Identifier:
NCT01056718
First received: January 25, 2010
Last updated: December 17, 2013
Last verified: December 2013
  Purpose

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. In patients with predominantly diastolic heart failure it is hypothesized that by using more robust echocardiographic measures of diastolic dysfunction, significant changes will be detected. Furthermore, due to the unique properties of nebivolol it is also hypothesized that there will be improvements in LV function manifesting as increased exercise capacity as well as LVH regression as measured by echocardiography. The investigators hope to reproduce the findings shown in a prior study that showed increased stroke volume and preservation of CO in subjects receiving nebivolol.


Condition Intervention
Hypertension
Drug: Nebivolol

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Nebivolol on Exercise Tolerance and Left Ventricular Systolic and Diastolic Function

Resource links provided by NLM:


Further study details as provided by St. John's Health System, Missouri:

Primary Outcome Measures:
  • Improvement in LV function. [ Time Frame: Week 2, 4, and Week 10 ] [ Designated as safety issue: Yes ]

Enrollment: 50
Study Start Date: November 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Starting on 5 mg of Nebivolol then titrated
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.
Drug: Nebivolol
Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 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 NYHA heart failure symptoms
  • CKD 3 or greater (CrCl <30 cc/min)
  • Subjects with active ischemia or evidence of ischemia on initial stress echocardiography
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01056718

Locations
United States, Missouri
St. John's Mercy Cardiovascular Research
St. Louis, Missouri, United States, 63141
Sponsors and Collaborators
St. John's Health System, Missouri
Forest Laboratories
Investigators
Principal Investigator: James A. Stokes, M.D. St. John's Mercy Heart & Vascular
  More Information

No publications provided

Responsible Party: James Stokes, MD, Cardiologist Mercy Hospital, St. John's Health System, Missouri
ClinicalTrials.gov Identifier: NCT01056718     History of Changes
Other Study ID Numbers: BYS-MD-32
Study First Received: January 25, 2010
Last Updated: December 17, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases
Nebivolol
Adrenergic Agents
Adrenergic Antagonists
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Antihypertensive Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on November 25, 2014