Home Blood Pressure in Hypertension Management (HBP10)
This study is currently recruiting participants.
Verified May 2012 by University of Athens
Sponsor:
University of Athens
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
| Tracking Information | |||||
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| First Received Date ICMJE | February 10, 2009 | ||||
| Last Updated Date | May 24, 2012 | ||||
| Start Date ICMJE | February 2009 | ||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE |
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 ] | ||||
| Change History | Complete list of historical versions of study NCT00841308 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Blood Pressure Control, Cost-Effectiveness [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Home Blood Pressure in Hypertension Management | ||||
| Official Title ICMJE | Antihypertensive Drug Treatment Decisions Based on Home Blood Pressure Monitoring | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Essential Hypertension | ||||
| Intervention ICMJE | 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). |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 150 | ||||
| Estimated Completion Date | December 2012 | ||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 25 Years to 80 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Greece | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00841308 | ||||
| Other Study ID Numbers ICMJE | HBP10 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | George S. Stergiou, University of Athens | ||||
| Study Sponsor ICMJE | University of Athens | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Athens | ||||
| Verification Date | May 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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