Home Blood Pressure in Hypertension Management (HBP10)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by University of Athens.
Recruitment status was  Recruiting
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

February 10, 2009
May 24, 2012
February 2009
December 2012   (final data collection date for primary outcome measure)
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 ]
Blood Pressure Control, Intermediate target organ damage (Left Ventricular Hypertrophy, Microalbuminuria, carotid-femoral Pulse Wave Velocity, Central blood pressure), Cost-Effectiveness [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00841308 on ClinicalTrials.gov Archive Site
Blood Pressure Control, Cost-Effectiveness [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Home Blood Pressure in Hypertension Management
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Essential Hypertension
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: Usual care
    Intervention: Other: Decision to start and titrate drug treatment based only on home blood pressure monitoring
  • Active Comparator: Home blood pressure monitoring
    Intervention: Other: Decision to start and titrate drug treatment based only on home blood pressure monitoring
Nasothimiou EG, Karpettas N, Dafni MG, Stergiou GS. Patients' preference for ambulatory versus home blood pressure monitoring. J Hum Hypertens. 2014 Apr;28(4):224-9. doi: 10.1038/jhh.2013.104. Epub 2013 Oct 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
25 Years to 80 Years
No
Contact: George S Stergiou, MD +30 210 7763117 gstergi@med.uoa.gr
Greece
 
NCT00841308
HBP10
No
George S. Stergiou, University of Athens
University of Athens
Not Provided
Study Chair: George S Stergiou, MD Hypertension Center, Third Depertment of Medicine, University of Athens, Greece
University of Athens
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP