To assess the efficacy of Left Ventricular Hypertrophy (LVH) reduction and 24-hour blood pressure control of Valsartan 80mg or Nebivolol/Valsartan 5/80mg once daily as replacement therapy for currently treated or untreated hypertensive patients with LVH not at BP goal.
The potential benefits of blood pressure reduction have been demonstrated in numerous large clinical trials. The most recent is the SPRINT Trial demonstrating that lower blood pressure goals can be achieved and are associated with a significant decrease in morbidity and mortality. The latest NHANES 2012 data reveal that less than 50% of patients that are aware of the elevated blood pressure and are being treated achieve blood pressure control. Treatment of hypertension in many patients (\>70%) require treatment with more than one drug, increasing the likelihood of non-compliance and not achieving blood pressure goal. JNC 8 recommends the utilizing of combination therapy both for Stage I and Stage II Hypertensive patients. Objectives of the study to assess the efficacy of LVH reduction and 24-hour blood pressure control of Valsartan 80mg and Nebivolol/Valsartan 5/80mg, once daily for the treatment of currently treated hypertensive patients with LVH. The study will evaluate LVH reduction at 4 and 8 weeks as well as change from baseline in mean 24 hour ABPM SBP after 4 and 8 weeks of treatment with valsartan 80mg or nebivolol/valsartan 5/80mg
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
30
Compare office and 24-hour Blood Pressure Control and regression of Left Ventricular Hypertrophy
Trinity Hypertension & Metabolic Research Institute
Carrollton, Texas, United States
LVH reduction at 4 weeks.
Reduction of Left ventricular hypertrophy from baseline compared to 4 weeks of treatment
Time frame: 4 weeks
24hr-ABPM measurement Change from baseline in mean 24 hour ABPM SBP
Reduction of Systolic BP over 24 hours baseline compared to 4 weeks of treatment
Time frame: 4 weeks
LVH reduction at 8 weeks.
Reduction of Left ventricular hypertrophy from baseline compared to 8 weeks of treatment
Time frame: 8 weeks
24hr-Systolic ABPM measurement
Reduction of Systolic BP over 24 hours baseline compared to 8 weeks of treatment
Time frame: 8 weeks
24hr- DBP ABPM measurements
Mean change from baseline in trough DBP after 4 and 8 weeks of treatment with valsartan 80mg or nebivolol/valsartan 5/80mg
Time frame: 4 and 8 weeks
Office Blood Pressure measurements
Mean change from baseline in trough SBP after 4 and 8 weeks of treatment with valsartan 80mg or nebivolol/valsartan 5/80mg
Time frame: 4 and 8 weeks
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