Home Blood Pressure in Hypertension Management

Phase 4

• Conditions: Essential Hypertension
• Interventions: Other: Decision to start and titrate drug treatment based only on home blood pressure monitoring

• Registration Number: NCT00841308
• Lead Sponsor: University of Athens

Brief Summary

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

Not available

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-02-10
• Study First Submitted QC: 2009-02-10
• Study First Posted: 2009-02-11
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-24
• Last Update Posted: 2012-05-25
• Primary Completion: 2012-12
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual care	Decision to start and titrate drug treatment based only on home blood pressure monitoring	-
Home blood pressure monitoring	Decision to start and titrate drug treatment based only on home blood pressure monitoring	-

Primary Outcome Measures

Name	Time	Method
Intermediate target organ damage (Left Ventricular Hypertrophy, Microalbuminuria, carotid-femoral Pulse Wave Velocity, Central blood pressure)	Baseline and 12 months

Secondary Outcome Measures

Name	Time	Method
Blood Pressure Control, Cost-Effectiveness	Baseline and 12 months

Trial Locations

Locations (1)

Hypertension Center, Third Department of Medicine, University of Athens, Greece; 🇬🇷 Athens, Greece