Back to resultsHome Blood Pressure-guided Antihypertensive Intervention for Elderly (HBP-GUIDE) Study
Primary Purpose
Cardiovascular Disease, Vascular Disease, Hypertension
Status
Withdrawn
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Home blood pressure measurement
Office blood pressure measurement
Sponsored by
About this trial
This is an interventional treatment trial for Cardiovascular Disease focused on measuring Cardiovascular disease, Vascular disease, Hypertension, Home blood pressure measurement
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
Sites / Locations
- Division of Internal Medicine, Kyoto Prefectural University of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Home blood pressure group
Office blood pressure group
Outcomes
Primary Outcome Measures
Home blood pressure
Office blood pressure
Secondary Outcome Measures
high sensitive C-reactive protein
Interleukin-6
urine microalbumin
Plasminogen activator inhibitor activity
B-type natriuretic peptide
Pulse wave velocity
Full Information
NCT ID
NCT00334724
First Posted
June 7, 2006
Last Updated
December 28, 2015
Sponsor
Kyoto University, Graduate School of Medicine
Collaborators
Kyoto Prefectural University of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT00334724
Brief Title
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
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Patients were not appropriately enrolled
Study Start Date
October 2006 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Kyoto University, Graduate School of Medicine
Collaborators
Kyoto Prefectural University of Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Disease, Vascular Disease, Hypertension
Keywords
Cardiovascular disease, Vascular disease, Hypertension, Home blood pressure measurement
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Home blood pressure group
Arm Title
2
Arm Type
Active Comparator
Arm Description
Office blood pressure group
Intervention Type
Procedure
Intervention Name(s)
Home blood pressure measurement
Intervention Description
Blood pressure controlled based on home blood pressure measurement
Intervention Type
Procedure
Intervention Name(s)
Office blood pressure measurement
Intervention Description
Blood pressure controlled based on office blood pressure measurement
Primary Outcome Measure Information:
Title
Home blood pressure
Time Frame
one year
Title
Office blood pressure
Time Frame
one year
Secondary Outcome Measure Information:
Title
high sensitive C-reactive protein
Time Frame
one year
Title
Interleukin-6
Time Frame
one year
Title
urine microalbumin
Time Frame
one year
Title
Plasminogen activator inhibitor activity
Time Frame
one year
Title
B-type natriuretic peptide
Time Frame
one year
Title
Pulse wave velocity
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hiroaki Matsubara, MD, PhD
Organizational Affiliation
Professor of Medicine, Department of Cardiovascular Medicine, Kyoto Prefectural University of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Internal Medicine, Kyoto Prefectural University of Medicine
City
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Home Blood Pressure-guided Antihypertensive Intervention for Elderly (HBP-GUIDE) Study
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