Home Blood Pressure in Hypertension Management
HBP10
Antihypertensive Drug Treatment Decisions Based on Home Blood Pressure Monitoring
1 other identifier
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Feb 2009
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 10, 2009
CompletedFirst Posted
Study publicly available on registry
February 11, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedMay 25, 2012
May 1, 2012
3.8 years
February 10, 2009
May 24, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Intermediate target organ damage (Left Ventricular Hypertrophy, Microalbuminuria, carotid-femoral Pulse Wave Velocity, Central blood pressure)
Baseline and 12 months
Secondary Outcomes (1)
Blood Pressure Control, Cost-Effectiveness
Baseline and 12 months
Study Arms (2)
Usual care
ACTIVE COMPARATORHome blood pressure monitoring
ACTIVE COMPARATORInterventions
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 Criteria
You may qualify if:
- Untreated hypertensive adults
- Treated hypertensive adults with uncontrolled blood pressure
You may not qualify if:
- Stage III Hypertension
- Secondary Hypertension
- Cardiovascular or Renal disease
- Uncontrolled Diabetes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hypertension Center, Third Department of Medicine, University of Athens, Greece
Athens, 11527, Greece
Related Publications (1)
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.
PMID: 24152822DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
George S Stergiou, MD
Hypertension Center, Third Depertment of Medicine, University of Athens, Greece
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Medicine and Hypertension
Study Record Dates
First Submitted
February 10, 2009
First Posted
February 11, 2009
Study Start
February 1, 2009
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
May 25, 2012
Record last verified: 2012-05