Home Blood Pressure in Hypertension Management

NCT ID: NCT00841308

Last Updated: 2012-05-25

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2012-12-31

Brief Summary

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This is a prospective randomized study with two arms: the Conventional and Ambulatory blood pressure monitoring arm and the Home blood pressure monitoring arm. The study will include both previously treated and untreated individuals.

Before randomization and in the end of the study, measurements will be performed using all three blood pressure monitoring methods (Conventional, Ambulatory and Home) as well as assessment of target organ damage (microalbuminuria, electrocardiogram, echocardiogram, carotid-femoral pulse wave velocity and central blood pressure).

The participants will be randomized into one of the two arms. Diagnosis and titration will be decided according to either Conventional and Ambulatory blood pressure measurements or according to Home blood pressure measurements. Subjects will be followed up for one year.

Detailed Description

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Conditions

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Essential Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Usual care

Group Type ACTIVE_COMPARATOR

Decision to start and titrate drug treatment based only on home blood pressure monitoring

Intervention Type OTHER

Drug Treatment according to current Hypertension Guidelines. Decision to start and titrate drug treatment based on clinic and ambulatory blood pressure ("Usual care" arm) versus based on home blood pressure monitoring only ("Home blood pressure monitoring" arm).

Home blood pressure monitoring

Group Type ACTIVE_COMPARATOR

Decision to start and titrate drug treatment based only on home blood pressure monitoring

Intervention Type OTHER

Drug Treatment according to current Hypertension Guidelines. Decision to start and titrate drug treatment based on clinic and ambulatory blood pressure ("Usual care" arm) versus based on home blood pressure monitoring only ("Home blood pressure monitoring" arm).

Interventions

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Decision to start and titrate drug treatment based only on home blood pressure monitoring

Drug Treatment according to current Hypertension Guidelines. Decision to start and titrate drug treatment based on clinic and ambulatory blood pressure ("Usual care" arm) versus based on home blood pressure monitoring only ("Home blood pressure monitoring" arm).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Untreated hypertensive adults
* Treated hypertensive adults with uncontrolled blood pressure

Exclusion Criteria

* Stage III Hypertension
* Secondary Hypertension
* Cardiovascular or Renal disease
* Uncontrolled Diabetes
Minimum Eligible Age

25 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Athens

OTHER

Sponsor Role lead

Responsible Party

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George S. Stergiou

Associate Professor of Medicine and Hypertension

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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George S Stergiou, MD

Role: STUDY_CHAIR

Hypertension Center, Third Depertment of Medicine, University of Athens, Greece

Locations

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Hypertension Center, Third Department of Medicine, University of Athens, Greece

Athens, , Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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George S Stergiou, MD

Role: CONTACT

+30 210 7763117

Facility Contacts

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George S Stergiou, MD

Role: primary

+30 210 7763117

References

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Nasothimiou EG, Karpettas N, Dafni MG, Stergiou GS. Patients' preference for ambulatory versus home blood pressure monitoring. J Hum Hypertens. 2014 Apr;28(4):224-9. doi: 10.1038/jhh.2013.104. Epub 2013 Oct 24.

Reference Type DERIVED
PMID: 24152822 (View on PubMed)

Other Identifiers

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HBP10

Identifier Type: -

Identifier Source: org_study_id

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