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

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ClinicalTrials.gov Identifier: NCT00334724
Recruitment Status : Withdrawn (Patients were not appropriately enrolled)
First Posted : June 8, 2006
Last Update Posted : December 29, 2015
Sponsor:
Collaborator:
Kyoto Prefectural University of Medicine
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Vascular Disease Hypertension Procedure: Home blood pressure measurement Procedure: Office blood pressure measurement Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Home Blood Pressure-guided Antihypertensive Intervention for Elderly (HBP-GUIDE) Study
Study Start Date : October 2006
Actual Primary Completion Date : November 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Home blood pressure [ Time Frame: one year ]
  2. Office blood pressure [ Time Frame: one year ]

Secondary Outcome Measures :
  1. high sensitive C-reactive protein [ Time Frame: one year ]
  2. Interleukin-6 [ Time Frame: one year ]
  3. urine microalbumin [ Time Frame: one year ]
  4. Plasminogen activator inhibitor activity [ Time Frame: one year ]
  5. B-type natriuretic peptide [ Time Frame: one year ]
  6. Pulse wave velocity [ Time Frame: one year ]


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Ages Eligible for Study:   65 Years to 80 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00334724


Locations
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Japan
Division of Internal Medicine, Kyoto Prefectural University of Medicine
Kyoto, Japan, 602-8566
Sponsors and Collaborators
Kyoto University, Graduate School of Medicine
Kyoto Prefectural University of Medicine
Investigators
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Principal Investigator: Hiroaki Matsubara, MD, PhD Professor of Medicine, Department of Cardiovascular Medicine, Kyoto Prefectural University of Medicine

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Responsible Party: Hiroaki Matsubara, Kyoto Prefectural University of Medicine
ClinicalTrials.gov Identifier: NCT00334724     History of Changes
Other Study ID Numbers: C-136
First Posted: June 8, 2006    Key Record Dates
Last Update Posted: December 29, 2015
Last Verified: December 2015

Keywords provided by Kyoto University, Graduate School of Medicine:
Cardiovascular disease
Vascular disease
Hypertension
Home blood pressure measurement

Additional relevant MeSH terms:
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Hypertension
Cardiovascular Diseases
Vascular Diseases
Antihypertensive Agents