Cardiovascular Disease, Hypertension, Vascular Disease
Conditions
Keywords
Cardiovascular disease, Vascular disease, Hypertension, Home blood pressure measurement
Brief summary
The purpose of this study is to determine whether blood pressure control by home blood pressure monitoring exerts beneficial cardioprotective effects rather than by clinic blood pressure monitoring in elderly patients.
Detailed description
Home blood pressure (BP) measurement has been reported to be closely correlated with target organ damage and appears to be a prognostic indicator with respect to cardiovascular mortality and cardiovascular events. However, whether BP control by home BP monitoring exerts cardioprotective effects rather than by clinic BP monitoring in elderly patients remains unknown. In this study, a total of 500 elderly patients diagnosed with essential hypertension will be randomly divided into 2 groups; target BP level, home SBP \<135 mmHg and home DBP \<85 mmHg (home BP control group), clinic SBP \<140 mmHg and clinic DBP \<90 mmHg (clinic BP control group). Olmesartan at doses of 20 mg/day will be administered and increased up to 40 mg, if antihypertensive effect is inadequate. Study visits will be made bimonthly for at least 1 year. The antihypertensive and cardioprotective effects including systemic levels of C-reactive protein and inflammatory cytokines, and arterial stiffness will be compared between the two groups.
Interventions
PROCEDUREHome blood pressure measurement
Blood pressure controlled based on home blood pressure measurement
PROCEDUREOffice blood pressure measurement
Blood pressure controlled based on office blood pressure measurement
Sponsors
Kyoto Prefectural University of Medicine
Kyoto University, Graduate School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Outpatients aged over 65 years and less than 80 years * Patients with a stable seated systolic blood pressure of ≥ 140 mmHg or diastolic blood pressure of ≥ 90 mmHg at two visits within 8 weeks * Patients with a stable seated systolic blood pressure of ≥ 135 mmHg or diastolic blood pressure of ≥ 85 mmHg at home (home blood pressure is measured every morning within 1 h of waking, and defined as the mean of 3 days measurement within 8 weeks)
Exclusion criteria
* Patients with secondary hypertension or malignant hypertension * Patients with a stable seated systolic pressure of ≥ 180 mmHg or diastolic pressure of ≥ 110 mmHg * Patients with renal dysfunction with a serum creatinine level of ≥ 2 mg/dl * Patients with liver dysfunction * Patients with a history of hypersensitivity to angiotensin II receptor blockade * Patients with a history of myocardial infarction within 6 months prior to enrolment in the study * Patients who underwent coronary arterioplasty within 6 months prior to enrolment in the study or patients who will undergo coronary arterioplasty within 6 months after entry * Patients with heart failure * Patients with a history of cerebrovascular disorder * Other patients who are judged to be inappropriate for the study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Home blood pressure | one year |
| Office blood pressure | one year |
Secondary
| Measure | Time frame |
|---|---|
| Pulse wave velocity | one year |
| Interleukin-6 | one year |
| Plasminogen activator inhibitor activity | one year |
| high sensitive C-reactive protein | one year |
| urine microalbumin | one year |
| B-type natriuretic peptide | one year |
Countries
Japan
Outcome results
None listed