Home Blood Pressure in Hypertension Management (HBP10)
Primary Purpose
Essential Hypertension
Status
Unknown status
Phase
Phase 4
Locations
Greece
Study Type
Interventional
Intervention
Decision to start and titrate drug treatment based only on home blood pressure monitoring
Sponsored by
About this trial
This is an interventional treatment trial for Essential Hypertension
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
Sites / Locations
- Hypertension Center, Third Department of Medicine, University of Athens, GreeceRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Usual care
Home blood pressure monitoring
Arm Description
Outcomes
Primary Outcome Measures
Intermediate target organ damage (Left Ventricular Hypertrophy, Microalbuminuria, carotid-femoral Pulse Wave Velocity, Central blood pressure)
Secondary Outcome Measures
Blood Pressure Control, Cost-Effectiveness
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00841308
Brief Title
Home Blood Pressure in Hypertension Management
Acronym
HBP10
Official Title
Antihypertensive Drug Treatment Decisions Based on Home Blood Pressure Monitoring
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Unknown status
Study Start Date
February 2009 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Athens
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Usual care
Arm Type
Active Comparator
Arm Title
Home blood pressure monitoring
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Decision to start and titrate drug treatment based only on home blood pressure monitoring
Intervention Description
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).
Primary Outcome Measure Information:
Title
Intermediate target organ damage (Left Ventricular Hypertrophy, Microalbuminuria, carotid-femoral Pulse Wave Velocity, Central blood pressure)
Time Frame
Baseline and 12 months
Secondary Outcome Measure Information:
Title
Blood Pressure Control, Cost-Effectiveness
Time Frame
Baseline and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
George S Stergiou, MD
Phone
+30 210 7763117
Email
gstergi@med.uoa.gr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George S Stergiou, MD
Organizational Affiliation
Hypertension Center, Third Depertment of Medicine, University of Athens, Greece
Official's Role
Study Chair
Facility Information:
Facility Name
Hypertension Center, Third Department of Medicine, University of Athens, Greece
City
Athens
ZIP/Postal Code
11527
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
George S Stergiou, MD
Phone
+30 210 7763117
Email
gstergi@med.uoa.gr
12. IPD Sharing Statement
Citations:
PubMed Identifier
24152822
Citation
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.
Results Reference
derived
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Home Blood Pressure in Hypertension Management
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