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

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.

Study Overview

• Status: Withdrawn
• Conditions: Hypertension; Cardiovascular Disease; Vascular Disease
• Intervention / Treatment: Procedure: Home blood pressure measurement; Procedure: Office blood pressure measurement

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 Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• Japan
  • Kyoto, Japan, 602-8566
    • Division of Internal Medicine, Kyoto Prefectural University of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 80 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; Home blood pressure group	Procedure: Home blood pressure measurement; Blood pressure controlled based on home blood pressure measurement
Active Comparator: 2; Office blood pressure group	Procedure: Office blood pressure measurement; Blood pressure controlled based on office blood pressure measurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Home blood pressure	one year
Office blood pressure	one year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Kyoto University, Graduate School of Medicine
• Collaborators: Kyoto Prefectural University of Medicine
• Investigators: Principal Investigator: Hiroaki Matsubara, MD, PhD, Professor of Medicine, Department of Cardiovascular Medicine, Kyoto Prefectural University of Medicine

Study record dates

Study Major Dates

• Study Start: October 1, 2006
• Primary Completion (Actual): November 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: June 7, 2006
• First Submitted That Met QC Criteria: June 7, 2006
• First Posted (Estimate): June 8, 2006

Study Record Updates

• Last Update Posted (Estimate): December 29, 2015
• Last Update Submitted That Met QC Criteria: December 28, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Cardiovascular disease; Hypertension; Vascular disease; Home blood pressure measurement
• Additional Relevant MeSH Terms: Hypertension; Cardiovascular Diseases; Vascular Diseases
• Other Study ID Numbers: C-136