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An Advanced Echocardiographic Evaluation of Nebivolol

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ClinicalTrials.gov Identifier: NCT01206439
Recruitment Status : Terminated (Slow enrollment)
First Posted : September 21, 2010
Results First Posted : November 25, 2015
Last Update Posted : December 1, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to determine if Nebivolol has any effect on heart function determined by changes in echocardiographic data or exercise tolerance.

Condition or disease Intervention/treatment Phase
Hypertension Drug: nebivolol Phase 4

Detailed Description:
Subjects will be given either 5 or 10 mg daily of oral Nebivolol for blood pressure control. They will undergo stress echocardiography at baseline, day 14, 90 and 180.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Advanced Echocardiographic Evaluation of Nebivolol
Study Start Date : September 2010
Primary Completion Date : August 2012
Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Nebivolol 5 or 10 mg, oral, daily
Subject will receive either 5 or 10 mg of oral nebivolol daily. Dose will be determined by control of blood pressure.
Drug: nebivolol
nebivolol 5 or 10 mg oral, daily
Other Name: Bystolic


Outcome Measures

Primary Outcome Measures :
  1. Change in Systolic and Diastolic Myocardial Function [ Time Frame: Baseline to day 180 ]
    Cannot report as only 1 patient was evaluated and data will not be able to remain anonymous.


Secondary Outcome Measures :
  1. Exercise Tolerance [ Time Frame: Baseline to day 180. ]
    Changes in exercise tolerance and time from baseline to 180 days.


Eligibility Criteria

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of hypertension
  2. Written informed consent before initiation of any study related procedure
  3. Baseline Blood pressure > 140 systolic or >90 diastolic if on no antihypertensive therapy.
  4. Currently taking one antihypertensive or one antihypertensive and one diuretic for the treatment of hypertension.

Exclusion Criteria:

  1. Physical limitations resulting in a limited ability to walk on treadmill for stress echo
  2. Intolerance to beta blockers
  3. On more than one medication for the treatment of hypertension unless the second medication is a diuretic.
  4. Currently pregnant or breast feeding.
  5. LFT > 3 X ULN
  6. HgA1C > 7
  7. Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within past 30 days of enrollment
  8. Unwilling to follow protocol or return for study related procedures.
  9. Any of the following conditions:

    Coronary artery disease Heart failure Valvular heart disease Ischemic heart disease Atrial fibrillation Pacemaker ICD Hyperlipidemia Diabetes Mellitus Stroke/TIA Anemia COPD Asthma Renal failure requiring dialysis Liver failure Cirrhosis Thyroid dysfunction

  10. Any other medical condition that in the PI's opinion could affect myocardial function.
  11. Current ETOH or illicit drug abuse -
Contacts and Locations

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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): NCT01206439


Locations
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Sponsors and Collaborators
Jack Rubinstein
Forest Laboratories
Investigators
Principal Investigator: Jack Rubinstein, MD University of Cincinnati
More Information

Responsible Party: Jack Rubinstein, Assistant Professor, University of Cincinnati
ClinicalTrials.gov Identifier: NCT01206439     History of Changes
Other Study ID Numbers: UC- 09-12-31-04
First Posted: September 21, 2010    Key Record Dates
Results First Posted: November 25, 2015
Last Update Posted: December 1, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
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