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

Phase 4

Withdrawn

• Conditions: Hypertension; Cardiovascular Disease; Vascular Disease
• Interventions: Procedure: Office blood pressure measurement; Procedure: Home blood pressure measurement

• Registration Number: NCT00334724
• Lead Sponsor: Kyoto University, Graduate School of Medicine

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.

Study Timeline

• Study First Submitted: 2006-06-07
• Study First Submitted QC: 2006-06-07
• Study First Posted: 2006-06-08
• Study Start: 2006-10
• Primary Completion: 2008-11
• Study Completion: 2008-12
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-28
• Last Update Posted: 2015-12-29

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Office blood pressure measurement	Office blood pressure group
1	Home blood pressure measurement	Home blood pressure group

Primary Outcome Measures

Name	Time	Method
Home blood pressure	one year
Office blood pressure	one year

Secondary Outcome Measures

Name	Time	Method
Plasminogen activator inhibitor activity	one year
Interleukin-6	one year
urine microalbumin	one year
Pulse wave velocity	one year
high sensitive C-reactive protein	one year
B-type natriuretic peptide	one year

Trial Locations

Locations (1)

Division of Internal Medicine, Kyoto Prefectural University of Medicine; 🇯🇵 Kyoto, Japan