Home Blood Pressure-guided Antihypertensive Intervention for Elderly (HBP-GUIDE) Study

Kyoto University, Graduate School of Medicine

Status and phase

Withdrawn

Phase 4

Conditions

Hypertension

Vascular Disease

Cardiovascular Disease

Treatments

Procedure: Home blood pressure measurement

Procedure: Office blood pressure measurement

Study type

Interventional

Funder types

Other

Identifiers

NCT00334724

C-136

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

65 to 80 years old

Volunteers

No Healthy Volunteers

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