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

NCT ID: NCT00334724

Last Updated: 2015-12-29

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2008-12-31

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.

Conditions

Cardiovascular Disease; Vascular Disease; Hypertension

Keywords

Cardiovascular disease; Vascular disease; Hypertension; Home blood pressure measurement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Home blood pressure group

Group Type: ACTIVE_COMPARATOR

Home blood pressure measurement

Intervention Type: PROCEDURE

Blood pressure controlled based on home blood pressure measurement

2

Office blood pressure group

Group Type: ACTIVE_COMPARATOR

Office blood pressure measurement

Intervention Type: PROCEDURE

Blood pressure controlled based on office blood pressure measurement

Interventions

Home blood pressure measurement

Blood pressure controlled based on home blood pressure measurement

Intervention Type: PROCEDURE

Office blood pressure measurement

Blood pressure controlled based on office blood pressure measurement

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kyoto Prefectural University of Medicine

OTHER

Sponsor Role: collaborator

Kyoto University, Graduate School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Kyoto Prefectural University of Medicine

Principal Investigators

Hiroaki Matsubara, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Professor of Medicine, Department of Cardiovascular Medicine, Kyoto Prefectural University of Medicine

Locations

Division of Internal Medicine, Kyoto Prefectural University of Medicine

Kyoto, Kyoto, Japan

Countries

Japan

Other Identifiers

C-136

Identifier Type: -

Identifier Source: org_study_id