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Japan Morning Surge-1 Study

NCT ID: NCT00285519

Last Updated: 2006-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-08-31

Study Completion Date

2005-08-31

Brief Summary

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The purpose of this study is to examine whether strict blood pressure (BP) control by doxazosin using home BP monitoring, especially targeting the morning BP level, can reduce hypertensive target organ damage.

Detailed Description

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Morning blood pressure may play an important role in the pathogenesis of hypertensive target organ damage. Increased sympathetic nerve activity is reported to be one of the mechanisms of morning hypertension; however, there are no available data that show whether strict home blood pressure control, especially in the morning period, can reduce target organ damage.We will evaluate whether strict morning blood pressure control by sympathetic nervous system blockade using an alfa-blocker, doxazosin, and with the addition of a beta-blocker if needed, can reduce hypertensive target organ damage.

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Doxazosin (drug)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Morning systolic blood pressure \>135 mmHg in a sitting position at home while on stable antihypertensive medication for at least 3 months

Exclusion Criteria

* History of heart failure
* Presence of orthostatic hypotension, dementia, malignancy and chronic inflammatory disease
* Taking an alfa-blocker or beta-blocker
* Atrial fibrillation or atrial flutter
Minimum Eligible Age

0 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Japan Heart Foundation

OTHER

Sponsor Role lead

Principal Investigators

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Kazuomi Kario, MD, PhD

Role: STUDY_CHAIR

Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine

Locations

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Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine

Shimotsuke, Tochigi, Japan

Site Status

Countries

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Japan

References

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Hoshide S, Parati G, Matsui Y, Shibazaki S, Eguchi K, Kario K. Orthostatic hypertension: home blood pressure monitoring for detection and assessment of treatment with doxazosin. Hypertens Res. 2012 Jan;35(1):100-6. doi: 10.1038/hr.2011.156. Epub 2011 Sep 15.

Reference Type DERIVED
PMID: 21918522 (View on PubMed)

Other Identifiers

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JHF-03-143

Identifier Type: -

Identifier Source: org_study_id