- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00841308
Home Blood Pressure in Hypertension Management (HBP10)
Antihypertensive Drug Treatment Decisions Based on Home Blood Pressure Monitoring
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
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Athens, Greece, 11527
- Recruiting
- Hypertension Center, Third Department of Medicine, University of Athens, Greece
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Contact:
- George S Stergiou, MD
- Phone Number: +30 210 7763117
- Email: gstergi@med.uoa.gr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Usual care
|
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).
|
Active Comparator: 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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Intermediate target organ damage (Left Ventricular Hypertrophy, Microalbuminuria, carotid-femoral Pulse Wave Velocity, Central blood pressure)
Time Frame: Baseline and 12 months
|
Baseline and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Blood Pressure Control, Cost-Effectiveness
Time Frame: Baseline and 12 months
|
Baseline and 12 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HBP10
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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