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

NCT00334724 | Withdrawn Phase 4 DMC

• 1 other identifier: C-136
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Disease; Vascular Disease; Hypertension

Keywords

Cardiovascular disease; Vascular disease; Hypertension; Home blood pressure measurement

Outcome Measures

Primary Outcomes (2)

• Home blood pressure

  one year

• Office blood pressure

  one year

Secondary Outcomes (6)

• 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

Study Arms (2)

1

ACTIVE COMPARATOR

Home blood pressure group

Procedure: Home blood pressure measurement

2

ACTIVE COMPARATOR

Office blood pressure group

Procedure: Office blood pressure measurement

Interventions

Home blood pressure measurement PROCEDURE

Blood pressure controlled based on home blood pressure measurement

1

Office blood pressure measurement PROCEDURE

Blood pressure controlled based on office blood pressure measurement

2

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Kyoto University, Graduate School of Medicine: lead
• Kyoto Prefectural University of Medicine: collaborator

Study Sites (1)

Division of Internal Medicine, Kyoto Prefectural University of Medicine

Kyoto, Kyoto, 602-8566, Japan

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Vascular Diseases; Hypertension

Study Officials

• Hiroaki Matsubara, MD, PhD

  Professor of Medicine, Department of Cardiovascular Medicine, Kyoto Prefectural University of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 7, 2006
• First Posted: June 8, 2006
• Study Start: October 1, 2006
• Primary Completion: November 1, 2008
• Study Completion: December 1, 2008
• Last Updated: December 29, 2015

Record last verified: 2015-12

Locations

JP (1)