Home Blood Pressure in Hypertension Management

Study Overview
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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.

Official Title
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Antihypertensive Drug Treatment Decisions Based on Home Blood Pressure Monitoring

Conditions
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Essential Hypertension

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


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual care<br> | Other: Decision to start and titrate drug treatment based only on home blood pressure monitoring<br>* 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).<br>|
| Active Comparator: Home blood pressure monitoring<br> | Other: Decision to start and titrate drug treatment based only on home blood pressure monitoring<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intermediate target organ damage (Left Ventricular Hypertrophy, Microalbuminuria, carotid-femoral Pulse Wave Velocity, Central blood pressure) |  | Baseline and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure Control, Cost-Effectiveness |  | Baseline and 12 months |