Home Blood Pressure in Hypertension Management

Overview

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.

Full Title of Study: “Antihypertensive Drug Treatment Decisions Based on Home Blood Pressure Monitoring”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2012

Interventions

  • 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).

Arms, Groups and Cohorts

  • Active Comparator: Usual care
  • Active Comparator: Home blood pressure monitoring

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Blood Pressure Control, Cost-Effectiveness
    • Time Frame: Baseline and 12 months

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 25 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Athens
  • Provider of Information About this Clinical Study
    • Principal Investigator: George S. Stergiou, Associate Professor of Medicine and Hypertension – University of Athens
  • Overall Official(s)
    • George S Stergiou, MD, Study Chair, Hypertension Center, Third Depertment of Medicine, University of Athens, Greece
  • Overall Contact(s)
    • George S Stergiou, MD, +30 210 7763117, gstergi@med.uoa.gr

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