Clinical trial NCT00334724: Home Blood Pressure-guided Antihypertensive Intervention for Elderly (HBP-GUIDE) Study
Official title: Home Blood Pressure-guided Antihypertensive Intervention for Elderly (HBP-GUIDE) Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Cardiovascular Disease
Vascular Disease
Hypertension
Keywords: Cardiovascular disease
Vascular disease
Hypertension
Home blood pressure measurement
Lead sponsor: Kyoto University, Graduate School of Medicine
Sponsor class: OTHER
Collaborators: name: Kyoto Prefectural University of Medicine
First posted: 2006-06-08
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Home blood pressure
timeFrame: one year
measure: Office blood pressure
timeFrame: one year
Secondary outcomes:
measure: high sensitive C-reactive protein
timeFrame: one year
measure: Interleukin-6
timeFrame: one year
measure: urine microalbumin
timeFrame: one year
measure: Plasminogen activator inhibitor activity
timeFrame: one year
measure: B-type natriuretic peptide
timeFrame: one year
measure: Pulse wave velocity
timeFrame: one year
Other outcomes:
Locations:
city: Kyoto
country: Japan
facility: Division of Internal Medicine, Kyoto Prefectural University of Medicine
Study officials:
affiliation: Professor of Medicine, Department of Cardiovascular Medicine, Kyoto Prefectural University of Medicine
name: Hiroaki Matsubara, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: