Status:
TERMINATED
An Advanced Echocardiographic Evaluation of Nebivolol
Lead Sponsor:
Jack Rubinstein
Collaborating Sponsors:
Forest Laboratories
Conditions:
Hypertension
Eligibility:
All Genders
20-60 years
Phase:
PHASE4
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.
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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 -
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01206439
Start Date
September 1 2010
End Date
August 1 2012
Last Update
February 15 2018
Active Locations (1)
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1
University of Cincinnati
Cincinnati, Ohio, United States, 45267