An Advanced Echocardiographic Evaluation of Nebivolol
Information source: University of Cincinnati
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: nebivolol (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University of Cincinnati Official(s) and/or principal investigator(s):
Jack Rubinstein, MD, Principal Investigator, Affiliation: University of Cincinnati
Overall contact:
Jack Rubinstein, MD, Phone: (513) 558-3487, Email: jack.rubinstein@uc.edu
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.
Clinical Details
Official title: An Advanced Echocardiographic Evaluation of Nebivolol
Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change in systolic and diastolic myocardial function
Secondary outcome: 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
Minimum age: 20 Years.
Maximum age: 60 Years.
Gender(s): Both.
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 -
Locations and Contacts
Jack Rubinstein, MD, Phone: (513) 558-3487, Email: jack.rubinstein@uc.edu
University of Cincinnati, Cincinnati, Ohio 45267, United States; Recruiting
Additional Information
Starting date: September 2010
Last updated: April 5, 2011
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