Ambulatory Versus Home Blood Pressure Measurement | NCT01132001

Studies
Ambulatory Versus Home Blood Pressure Measurement

NCT01132001

Sponsor

University of Athens

Status

Unknown status

Last Update Posted

Oct 11, 2012Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

Arterial Hypertension

Interventions

Not provided

Countries

Greece

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

Nov 2012Estimated

Completion Date

Dec 2012Estimated

First Submitted Date

May 26, 2010

First Submission Date that Met QC Criteria

May 26, 2010

First Posted Date

May 27, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 9, 2012

Last Update Posted Date

Oct 11, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

George S. Stergiou, Associate Professor of Medicine and Hypertension, University of AthensPrincipal Investigator

Lead Sponsor

University of AthensOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blood pressure monitoring methods	Comparison among clinic, home and ambulatory blood pressure measurements.	Baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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%)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Subjects referred to an outpatient hyperetension clinic for arterial hypertension

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
George S Stergiou, MD	Contact	+302107763117		gstergi@med.uoa.gr

Overall Officials

Name	Affiliation	Role
George S Stergiou, MD	Hypertension Center,Third Department of Medicine,University of Athens,Greece	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hypertension Center, Third Department of Medicine, University of Athens, Greece	Recruiting	Athens			Greece

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided