Home Blood Pressure in Hypertension Management

Essential Hypertension Clinical Trial

— HBP10  

Official title:

Antihypertensive Drug Treatment Decisions Based on Home Blood Pressure Monitoring

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00841308
• Other study ID #: HBP10
• Status: Unknown status
• Phase: Phase 4
• First received: February 10, 2009
• Last updated: May 24, 2012
• Start date: February 2009
• Est. completion date: December 2012

Study information

• Verified date: May 2012
• Source: University of Athens
• Contact: George S Stergiou, MD
• Phone: +30 210 7763117
• Email: gstergi[@]med.uoa.gr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 150
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

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).

Locations

Country	Name	City	State
Greece	Hypertension Center, Third Department of Medicine, University of Athens, Greece	Athens

Sponsors (1)

Lead Sponsor	Collaborator
University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intermediate target organ damage (Left Ventricular Hypertrophy, Microalbuminuria, carotid-femoral Pulse Wave Velocity, Central blood pressure)		Baseline and 12 months
Secondary	Blood Pressure Control, Cost-Effectiveness		Baseline and 12 months