A randomized,double-blind, active controlled,15 week study to evaluate the effects of nebivolol and valsartan alone and in combination on 24-hour ambulatory cardiac work and variability of heart rate-mean central systolic pressure product.
Subjects with hypertension (systolic blood pressure (SBP) \>140 or diastolic blood pressure (DBP)\>90, n=26) were studied using a double-blinded, forced-titration, sequence-controlled, crossover design with 3 experimental periods: Valsartan 320, nebivolol 40, and nebivolol/valsartan 320/40 mg daily. After 4 weeks of each drug, ambulatory pulse wave analysis (IEM MobilOGraph) was performed every 20 min for 24-hours. The primary hypothesis was that nebivolol/valsartan combination therapy would be superior to valsartan monotherapy in reducing mean 24-hour mean myocardial oxygen consumption determined by 24-hour ambulatory heart rate-central systolic pressure product \[ACRPP\]. A secondary hypothesis was that the combination would also reduce the variability of 24-hour myocardial oxygen consumption.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
26
Nebivolol 20 mg daily (1 week) followed by nebivolol 40 mg daily (3 weeks) followed by nebivolol 20 mg daily (1 week)
Valsartan 160 mg daily (1 week) followed by valsartan 320 mg daily (3 weeks) followed by valsartan 160 mg daily (1 week).
Valsartan/Nebivolol, 160/20 mg daily (1 week) followed by valsartan/nebivolol 320/40 mg daily (3 weeks) followed by valsartan/nebivolol 160/20 mg daily (1 week)
Erie County Medical Center
Buffalo, New York, United States
ACRPP: 24-hour Ambulatory Central Rate-pressure Product (Also Called TTI, CTTI)
ACRPP is the product of estimated aortic mean systolic pressure (mean aortic pressure estimated using a transfer function applied to brachial cuff blood pressure) during the systolic time interval adjusted for heart rate. Units are (mmHg\*beats/min).
Time frame: measurement after 4 weeks in each treatment arm
Cuff SBP
Seated office cuff systolic blood pressure (mmHg)
Time frame: After 4 weeks in each treatment arm
Cuff DBP
Seated office cuff diastolic blood pressure (mmHg)
Time frame: After 4 weeks in each treatment arm
Ambulatory Brachial Double Product
24-hour mean heart rate x 24-hour mean systolic BP
Time frame: After 4 weeks in each treatment arm
Ambulatory Mean Heart Rate
Mean heart rate over 24 hours
Time frame: After 4 weeks in each treatment arm
Ambulatory Mean Central Diastolic BP
Mean ambulatory aortic (central) diastolic pressure over 24 hours
Time frame: After 4 weeks in each treatment arm
24-hour Brachial Systolic BP
Mean 24-hour ambulatory systolic BP
Time frame: 4 weeks
24-hour Brachial Diastolic BP
Mean 24-hour ambulatory cuff diastolic BP
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: After 4 weeks in each treatment arm
Daytime ACRPP (Ambulatory Central Rate-Pressure Product (Also Called TTI, CTTI)
Determined by ambulatory heart rate-central systolic pressure product during self-reported waking hours at the end of each study phase
Time frame: After 4 weeks in each treatment arm
Nighttime ACRPP
Determined by ambulatory heart rate-central systolic pressure product during self-reported sleeping hours
Time frame: After 4 weeks in each treatment arm
Daytime Heart Rate
Mean ambulatory heart rate during self-reported waking hours
Time frame: After 4 weeks in each treatment arm
Nighttime Heart Rate
Mean ambulatory heart rate during self-reported sleeping hours
Time frame: 4 weeks
Daytime Central Systolic Pressure
Mean ambulatory central systolic pressure during self-reported waking hours
Time frame: After 4 weeks in each treatment arm
Nighttime Central Systolic Pressure
Mean ambulatory central systolic pressure during self-reported sleeping hours
Time frame: 4 weeks
Daytime Brachial Systolic Pressure
Mean ambulatory brachial systolic pressure during self-reported waking hours
Time frame: After 4 weeks in each treatment arm
Nighttime Brachial Systolic Pressure
Mean ambulatory brachial systolic pressure during self-reported sleeping hours
Time frame: 4 weeks
Daytime Central Diastolic Pressure
Mean ambulatory central diastolic pressure during self-reported waking hours
Time frame: 4 weeks
Nighttime Central Diastolic Pressure
Mean ambulatory central diastolic pressure during self-reported sleeping hours
Time frame: After 4 weeks in each treatment arm
Daytime Brachial Diastolic Pressure
Mean ambulatory brachial diastolic pressure during self-reported waking hours
Time frame: 4 weeks
Nighttime Brachial Diastolic Pressure
Mean ambulatory brachial diastolic pressure during self-reported sleeping hours
Time frame: After 4 weeks in each treatment arm
Ambulatory Daytime Brachial Rate-pressure Product
Mean ambulatory heart rate x brachial systolic blood pressure product during self-reported waking hours
Time frame: After 4 weeks in each treatment arm
Ambulatory Nighttime Brachial Rate-pressure Product
Mean ambulatory heart rate x brachial systolic blood pressure product during self-reported sleeping hours
Time frame: After 4 weeks in each treatment arm