NCT01132001

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

October 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 27, 2010

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

October 11, 2012

Status Verified

October 1, 2012

Enrollment Period

3.1 years

First QC Date

May 26, 2010

Last Update Submit

October 9, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • Blood pressure monitoring methods

    Comparison among clinic, home and ambulatory blood pressure measurements.

    Baseline

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects referred to an outpatient hyperetension clinic for arterial hypertension

You may qualify if:

  • 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

You may not qualify if:

  • 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%)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hypertension Center, Third Department of Medicine, University of Athens, Greece

Athens, Greece

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • George S Stergiou, MD

    Hypertension Center,Third Department of Medicine,University of Athens,Greece

    STUDY CHAIR

Central Study Contacts

George S Stergiou, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine and Hypertension

Study Record Dates

First Submitted

May 26, 2010

First Posted

May 27, 2010

Study Start

October 1, 2009

Primary Completion

November 1, 2012

Study Completion

December 1, 2012

Last Updated

October 11, 2012

Record last verified: 2012-10

Locations