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Home Blood Pressure in Hypertension Management (HBP10)

This study is currently recruiting participants.
Verified May 2012 by University of Athens
Sponsor:
Information provided by (Responsible Party):
George S. Stergiou, University of Athens
ClinicalTrials.gov Identifier:
NCT00841308
First received: February 10, 2009
Last updated: May 24, 2012
Last verified: May 2012
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Antihypertensive Drug Treatment Decisions Based on Home Blood Pressure Monitoring

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Athens:

Primary Outcome Measures:
  • Intermediate target organ damage (Left Ventricular Hypertrophy, Microalbuminuria, carotid-femoral Pulse Wave Velocity, Central blood pressure) [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood Pressure Control, Cost-Effectiveness [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: February 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility

Ages Eligible for Study:   25 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: February 10, 2009
Last Updated: May 24, 2012
Health Authority: Greece: Ethics Committee

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
 Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013