The study examined the efficacy of LCZ696 in comparison to the ARB olmesartan on Central Aortic Systolic Blood Pressure (CASP) and other measures of central hemodynamics and arterial stiffness in elderly patients with an elevated systolic blood pressure (SBP) and widened pulse pressure (PP).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
454
Change From Baseline in Mean Central Aortic Systolic Pressure (CASP) at 12 Weeks
Central aortic blood pressure was derived from peripheral pressure waveforms recorded noninvasively from the brachial artery using a cuff-based device. This technique uses the brachial pressure and a signal processing algorithm to transform brachial signals into central blood pressure (BP) waveforms. When the aortic pressure waveform was derived, key pulse wave analysis (PWA) parameters, such as CASP was calculated by the system software. At the first study visit, the arm with the highest systolic blood pressure (SBP) was used for all subsequent PWA. Brachial PWA measurements were performed on the same arm that the office blood pressures were taken. Two pulse waveform measurements, meeting all quality control criteria were captured at baseline and at week 12 visits.
Time frame: baseline, 12 weeks
Change From Baseline in Mean Central Pulse (CPP) Pressure
Time frame: Baseline, 12 weeks, and 52 weeks
Change From Baseline in Mean Pulse Wave Velocity (PWV)
Pulse wave velocity recordings were performed on patient while in a supine, face-up position. Tonometry was performed on the carotid simultaneously with the cuff inflation over the femoral artery. Two pulse wave velocity measures, meeting all quality control criteria were captured at baseline, week 12 and week 52.
Time frame: baseline, 12 weeks, and 52 weeks
Change From Baseline in Mean Central Aortic Systolic Pressure (CASP) at 52 Weeks
Central aortic blood pressure was derived from peripheral pressure waveforms recorded noninvasively from the brachial artery using a cuff-based device. This technique uses the brachial pressure and a signal processing algorithm to transform brachial signals into central blood pressure (BP) waveforms. When the aortic pressure waveform was derived, key pulse wave analysis (PWA) parameters, such as CASP was calculated by the system software. At the first study visit, the arm with the highest systolic blood pressure (SBP) was used for all subsequent PWA. Brachial PWA measurements were performed on the same arm that the office blood pressures were taken. Two pulse waveform measurements, meeting all quality control criteria were captured at baseline and at week 12 visits.
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Olmesartan matching placebo capsule
amlodipine 2.5 mg or 5 mg tablets
hydrochlorothiazide 6.25mg, 12.5mg, or 25 mg tablets
Novartis Investigative Site
Clearwater, Florida, United States
Novartis Investigative Site
Chicago, Illinois, United States
Novartis Investigative Site
Baltimore, Maryland, United States
Novartis Investigative Site
Belzoni, Mississippi, United States
Novartis Investigative Site
Jackson, Mississippi, United States
Novartis Investigative Site
St Louis, Missouri, United States
Novartis Investigative Site
Buffalo, New York, United States
Novartis Investigative Site
Cincinnati, Ohio, United States
Novartis Investigative Site
Houston, Texas, United States
Novartis Investigative Site
Lake Jackson, Texas, United States
...and 37 more locations
Time frame: baseline, 52 weeks
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
At the first study visit, the patient had his/her blood pressure (BP) measured in both arms; the arm in which the highest sitting SBP was found was used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for 5 minutes, SBP were measured 3 times using a standard mercury sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1- to 2-minute intervals and the mean of those 3 measurements was used as the average sitting office BP for that visit.
Time frame: baseline, 12 weeks, and 52 weeks
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)
At the first study visit, the patient had his/her blood pressure (BP) measured in both arms; the arm in which the highest sitting SBP was found was used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for 5 minutes, DBP were measured 3 times using a standard mercury sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 1- to 2-minute intervals and the mean of those 3 measurements was used as the average sitting office BP for that visit.
Time frame: baseline, 12 weeks, and 52 weeks
Change From Baseline in Mean Sitting Pulse Pressure (msPP)
Mean sitting pulse pressure for each patient and visit was calculated as the difference between the calculated values of mean sitting systolic blood pressure and mean sitting diastolic blood pressure.
Time frame: baseline, 12 weeks, and 52 weeks
Change From Baseline in Mean Arterial Pressure (MAP)
Mean arterial pressure (MAP) was calculated from mean sitting systolic BP (msSBP) and mean sitting diastolic BP (msDBP) as (2 \* msDBP + msSBP)/3.
Time frame: baseline, 12 weeks, and 52 weeks
Change From Baseline in Mean 24-hour Systolic Blood Pressure (maSBP)
An Ambulatory Blood Pressure Monitor (ABPM) measured a participant's blood pressure over a 24 hour period using an automated validated monitoring device at baseline, week 12 and at week 52 starting one day before each visit. The 24 hour maSBP was calculated by taking the mean of all ambulatory systolic blood pressure readings for the 24 hour period.
Time frame: Baseline, 12 weeks, and 52 weeks
Change From Baseline in Mean 24-hour Diastolic Blood Pressure (maDBP)
An Ambulatory Blood Pressure Monitor (ABPM) measured a participant's blood pressure over a 24 hour period using an automated validated monitoring device at baseline, week 12 and at week 52 starting one day before each visit. The 24 hour maDBP was calculated by taking the mean of all ambulatory systolic blood pressure readings for the 24 hour period.
Time frame: Baseline, 12 weeks, and 52 weeks
Change From Baseline in Mean 24-hour Ambulatory Pulse Pressure (maPP)
Mean 24 hour ambulatory pulse pressure was calculated as the difference between the mean 24 hour systolic and diastolic ambulatory blood pressure in corresponding visits i.e. baseline, week 12 and week 52.
Time frame: Baseline, 12 weeks, and 52 weeks