An Advanced Echocardiographic Evaluation of Nebivolol
This study has been terminated.
Information provided by (Responsible Party):
Jack Rubinstein, University of Cincinnati
First received: April 2, 2010
Last updated: October 30, 2012
Last verified: October 2012
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.
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||An Advanced Echocardiographic Evaluation of Nebivolol
Primary Outcome Measures:
- Change in systolic and diastolic myocardial function [ Time Frame: Baseline to day 180 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||August 2012 (Final data collection date for primary outcome measure)
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.
nebivolol 5 or 10 mg oral, daily
Other Name: Bystolic
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.
|Ages Eligible for Study:
||20 Years to 60 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Diagnosis of hypertension
- Written informed consent before initiation of any study related procedure
- Baseline Blood pressure > 140 systolic or >90 diastolic if on no antihypertensive therapy.
- Currently taking one antihypertensive or one antihypertensive and one diuretic for the treatment of hypertension.
- Physical limitations resulting in a limited ability to walk on treadmill for stress echo
- Intolerance to beta blockers
- On more than one medication for the treatment of hypertension unless the second medication is a diuretic.
- Currently pregnant or breast feeding.
- LFT > 3 X ULN
- HgA1C > 7
- Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within past 30 days of enrollment
- Unwilling to follow protocol or return for study related procedures.
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
- Any other medical condition that in the PI's opinion could affect myocardial function.
- Current ETOH or illicit drug abuse -
Please refer to this study by its ClinicalTrials.gov identifier: NCT01206439
|University of Cincinnati
|Cincinnati, Ohio, United States, 45267 |
||Jack Rubinstein, MD
||University of Cincinnati
No publications provided
||Jack Rubinstein, Assistant Professor, University of Cincinnati
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 2, 2010
||October 30, 2012
||United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 06, 2014
Adrenergic beta-1 Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs