Ambulatory Blood Pressure Monitoring for Antihypertensive Treatment Guidance

NCT ID: NCT00139984

Last Updated: 2017-02-02

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

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2007-05-31

Brief Summary

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The purpose of this study is to determine whether in patients with arterial hypertension, treatment guidance using 24-hour blood pressure measurement results in better blood pressure control compared to treatment guidance using office blood pressure measurement.

Detailed Description

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Blood pressure control in arterial hypertension remains poor, despite the availability of effective drug treatment. Therefore, strategies to increase blood pressure control are urgently needed. 24 hour blood pressure is a better predictor of cardiovascular morbidity and mortality than office blood pressure. Furthermore, the lower variability of measurements over time of 24 hour blood pressure could allow better adjustment of antihypertensive therapy. However, there are only scarce data about antihypertensive treatment adjustment using 24 hour blood pressure instead of office blood pressure.

Aim: To test the hypothesis that a 24 hour blood pressure guided therapy is is more effective in reaching blood pressure control when compared to conventional office blood pressure guided therapy.

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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24 hour blood pressure measurement

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Uncontrolled hypertension (office BP \>139/89mmHg AND 24h BP \>129/79mmHg)

Exclusion Criteria

* Severe concomitant illness including heart failure, significant valvular heart disease or malignancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Conen, MD

Role: PRINCIPAL_INVESTIGATOR

Cardiology, University Hospital Basel

Locations

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Medical Outpatient Clinic, University Hospital Basel

Basel, , Switzerland

Site Status

Private Practice

Basel, , Switzerland

Site Status

Countries

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Switzerland

References

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Conen D, Tschudi P, Martina B. Twenty-four hour ambulatory blood pressure for the management of antihypertensive treatment: a randomized controlled trial. J Hum Hypertens. 2009 Feb;23(2):122-9. doi: 10.1038/jhh.2008.106. Epub 2008 Aug 28.

Reference Type DERIVED
PMID: 18754021 (View on PubMed)

Other Identifiers

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EKBB183/03

Identifier Type: -

Identifier Source: org_study_id

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