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Home Blood Pressure in Hypertension Management (HBP10)

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ClinicalTrials.gov Identifier: NCT00841308
Recruitment Status : Unknown
Verified May 2012 by George S. Stergiou, University of Athens.
Recruitment status was:  Recruiting
First Posted : February 11, 2009
Last Update Posted : May 25, 2012
Sponsor:
Information provided by (Responsible Party):
George S. Stergiou, 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.


Condition or disease Intervention/treatment Phase
Essential Hypertension Other: Decision to start and titrate drug treatment based only on home blood pressure monitoring Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Antihypertensive Drug Treatment Decisions Based on Home Blood Pressure Monitoring
Study Start Date : February 2009
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012

Arm Intervention/treatment
Active Comparator: Usual care Other: 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).
Active Comparator: Home blood pressure monitoring Other: 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).



Primary Outcome Measures :
  1. Intermediate target organ damage (Left Ventricular Hypertrophy, Microalbuminuria, carotid-femoral Pulse Wave Velocity, Central blood pressure) [ Time Frame: Baseline and 12 months ]

Secondary Outcome Measures :
  1. Blood Pressure Control, Cost-Effectiveness [ Time Frame: Baseline and 12 months ]


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Ages Eligible for Study:   25 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00841308


Contacts
Contact: George S Stergiou, MD +30 210 7763117 gstergi@med.uoa.gr

Locations
Greece
Hypertension Center, Third Department of Medicine, University of Athens, Greece Recruiting
Athens, Greece, 11527
Contact: George S Stergiou, MD    +30 210 7763117    gstergi@med.uoa.gr   
Sponsors and Collaborators
University of Athens
Investigators
Study Chair: George S Stergiou, MD Hypertension Center, Third Depertment of Medicine, University of Athens, Greece

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: George S. Stergiou, Associate Professor of Medicine and Hypertension, University of Athens
ClinicalTrials.gov Identifier: NCT00841308     History of Changes
Other Study ID Numbers: HBP10
First Posted: February 11, 2009    Key Record Dates
Last Update Posted: May 25, 2012
Last Verified: May 2012

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases