An Advanced Echocardiographic Evaluation of Nebivolol

This study has been terminated.
(Slow enrollment)
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Jack Rubinstein, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT01206439
First received: April 2, 2010
Last updated: October 30, 2012
Last verified: October 2012

April 2, 2010
October 30, 2012
September 2010
August 2012   (final data collection date for primary outcome measure)
Change in systolic and diastolic myocardial function [ Time Frame: Baseline to day 180 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01206439 on ClinicalTrials.gov Archive Site
Exercise tolerance [ Time Frame: Baseline to day 180. ] [ Designated as safety issue: No ]
Changes in exercise tolerance and time from baseline to 180 days.
Same as current
Not Provided
Not Provided
 
An Advanced Echocardiographic Evaluation of Nebivolol
An Advanced Echocardiographic Evaluation of Nebivolol

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.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypertension
Drug: nebivolol
nebivolol 5 or 10 mg oral, daily
Other Name: Bystolic
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.
Intervention: Drug: nebivolol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2
August 2012
August 2012   (final data collection date for primary outcome measure)

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 -
Both
20 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01206439
UC- 09-12-31-04
No
Jack Rubinstein, University of Cincinnati
Jack Rubinstein
Forest Laboratories
Principal Investigator: Jack Rubinstein, MD University of Cincinnati
University of Cincinnati
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP