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Clinical Trials/NCT00841308
NCT00841308
Unknown
Phase 4

Antihypertensive Drug Treatment Decisions Based on Home Blood Pressure Monitoring

University of Athens1 site in 1 country150 target enrollmentFebruary 2009

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Essential Hypertension
Sponsor
University of Athens
Enrollment
150
Locations
1
Primary Endpoint
Intermediate target organ damage (Left Ventricular Hypertrophy, Microalbuminuria, carotid-femoral Pulse Wave Velocity, Central blood pressure)
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2009
End Date
December 2012
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Athens
Responsible Party
Principal Investigator
Principal Investigator

George S. Stergiou

Associate Professor of Medicine and Hypertension

University of Athens

Eligibility 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

Outcomes

Primary Outcomes

Intermediate target organ damage (Left Ventricular Hypertrophy, Microalbuminuria, carotid-femoral Pulse Wave Velocity, Central blood pressure)

Time Frame: Baseline and 12 months

Secondary Outcomes

  • Blood Pressure Control, Cost-Effectiveness(Baseline and 12 months)

Study Sites (1)

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