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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00334724
• Other study ID #: C-136
• Status: Withdrawn
• Phase: Phase 4
• First received: June 7, 2006
• Last updated: December 28, 2015
• Start date: October 2006
• Est. completion date: December 2008

Study information

• Verified date: December 2015
• Source: Kyoto University, Graduate School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Hypertension
• Vascular Disease
• Vascular Diseases

Intervention

Procedure:
• Home blood pressure measurement
Blood pressure controlled based on home blood pressure measurement
• Office blood pressure measurement
Blood pressure controlled based on office blood pressure measurement

Locations

Country	Name	City	State
Japan	Division of Internal Medicine, Kyoto Prefectural University of Medicine	Kyoto

Sponsors (2)

Lead Sponsor	Collaborator
Kyoto University, Graduate School of Medicine	Kyoto Prefectural University of Medicine

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Home blood pressure		one year	No
Primary	Office blood pressure		one year	No
Secondary	high sensitive C-reactive protein		one year	No
Secondary	Interleukin-6		one year	No
Secondary	urine microalbumin		one year	No
Secondary	Plasminogen activator inhibitor activity		one year	No
Secondary	B-type natriuretic peptide		one year	No
Secondary	Pulse wave velocity		one year	No