Ambulatory Versus Home Blood Pressure Measurement

Arterial Hypertension Clinical Trial

Official title:

EVALUATION OF BLOOD PRESSURE MEASUREMENTS OUTSIDE OFFICE: COMPARISON OF DIAGNOSIS BASED ON EITHER AMBULATORY OR HOME BLOOD PRESSURE MEASUREMENTS

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01132001
• Other study ID #: HBP5
• Status: Recruiting
• Phase: N/A
• First received: May 26, 2010
• Last updated: October 9, 2012
• Start date: October 2009
• Est. completion date: December 2012

Study information

• Verified date: October 2012
• Source: University of Athens
• Contact: George S Stergiou, MD
• Phone: +302107763117
• Email: gstergi[@]med.uoa.gr
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Observational

Clinical Trial Summary

This is a prospective study comparing the three blood pressure monitoring methods on the diagnosis of arterial hypertension. Blood pressure of each subject will be evaluated with clinic, home and 24h ambulatory blood pressure measurements in three visits

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 90 Years

Eligibility

Inclusion Criteria:

• Age > 20 yrs

• Patients referred to an outpatient clinic for high blood pressure

• Patients with no treatment or with antihypertensive treatment stable for at least 4 weeks.

• Patients capable of performing home blood pressure measurements.

• Signed informed consent

Exclusion Criteria:

• Hypertension stage III (SBP>180 mmHg or DBP>110mmHg)

• Secondary hypertension

• Resistant hypertension

• Arrhythmia

• Pregnancy

• Symptomatic heart disease

• Renal disease (Cr>2mg/dl)

• Uncontrolled diabetes mellitus (HbA1c>8.5%)

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Arterial Hypertension
• Hypertension

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	Blood pressure monitoring methods	Comparison among clinic, home and ambulatory blood pressure measurements.	Baseline	No