Trials / Withdrawn
WithdrawnNCT00334724
Home Blood Pressure-guided Antihypertensive Intervention for Elderly (HBP-GUIDE) Study
- Status
- Withdrawn
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Kyoto University, Graduate School of Medicine · Academic / Other
- Sex
- All
- Age
- 65 Years – 80 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Home blood pressure measurement | Blood pressure controlled based on home blood pressure measurement |
| PROCEDURE | Office blood pressure measurement | Blood pressure controlled based on office blood pressure measurement |
Timeline
- Start date
- 2006-10-01
- Primary completion
- 2008-11-01
- Completion
- 2008-12-01
- First posted
- 2006-06-08
- Last updated
- 2015-12-29
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT00334724. Inclusion in this directory is not an endorsement.