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 -
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: 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 August 28, 2014
Adrenergic beta-1 Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs