Home Blood Pressure in Hypertension Management (HBP10)

National and Kapodistrian University of Athens

Status and phase: Unknown; Phase 4

Conditions: Essential Hypertension

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00841308

HBP10

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 25 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Usual care

Active Comparator group

Treatment:

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

Home blood pressure monitoring

Active Comparator group

Treatment:

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