NCT01460732

Brief Summary

This is a cross-sectional study, including adults, either untreated for hypertension, or under stable treatment for more than four weeks. Assessment will include: Clinic blood pressure measurements with an automated oscillometric device, 24-hour ambulatory blood pressure monitoring Home blood pressure monitoring during morning, evening and nocturnal measurements with the same device.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
81

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Nov 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 27, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
6 months until next milestone

Results Posted

Study results publicly available

June 12, 2012

Completed
Last Updated

July 10, 2012

Status Verified

July 1, 2012

Enrollment Period

1.1 years

First QC Date

October 25, 2011

Results QC Date

February 5, 2012

Last Update Submit

July 8, 2012

Conditions

Hypertension

Keywords

HypertensionNocturnal BP dippingHome Blood pressure MonitoringAmbulatory Blood Pressure Monitoring

Outcome Measures

Primary Outcomes (8)

  • Awake Systolic Home Blood Pressure Measurement

    Awake Home Blood Pressure measurement includes duplicate BP measurements in the morning and in the evening, as per protocol.

    2 weeks

  • Awake Diastolic Home Blood Pressure Measurement

    Awake Home Blood Pressure measurement includes duplicate BP measurements in the morning and in the evening, as per protocol.

    2 weeks

  • Asleep Systolic Home Blood Pressure Measurement

    Home Blood Pressure measurement device was applied by the patient himself, in order to perform BP measurements during sleep, as per protocol.

    2 weeks

  • Asleep Diastolic Home Blood Pressure Measurement

    Home Blood Pressure measurement device was applied by the patient himself, in order to perform BP measurements during sleep, as per protocol.

    2 weeks

  • Awake Systolic Ambulatory Blood Pressure Measurement

    An Ambulatory Blood Pressure Measurement device is applied by a doctor to each patient for 24 hours and next day it is removed. Measurements taken during patient's awake and asleep hours are analyzed separately.

    2 weeks

  • Awake Diastolic Ambulatory Blood Pressure Measurement

    An Ambulatory Blood Pressure Measurement device is applied by a doctor to each patient for 24 hours and next day it is removed. Measurements taken during patient's awake and asleep hours are analyzed separately.

    2 weeks

  • Asleep Systolic Ambulatory Blood Pressure Measurement

    An Ambulatory Blood Pressure Measurement device is applied by a doctor to each patient for 24 hours and next day it is removed. Measurements taken during patient's awake and asleep hours are analyzed separately.

    2weeks

  • Asleep Diastolic Ambulatory Blood Pressure Measurement

    An Ambulatory Blood Pressure Measurement device is applied by a doctor to each patient for 24 hours and next day it is removed. Measurements taken during patient's awake and asleep hours are analyzed separately.

    2weeks

Secondary Outcomes (1)

  • Dippers Defined by ABPM and HBPM-Nocturnal

    2 weeks

Study Arms (1)

All patients

OTHER

All eligible patients in the study consist a single group and the same intervention is assigned to all of them.

Device: Blood Pressure Monitoring

Interventions

Blood Pressure MonitoringDEVICE

Home Blood pressure Monitoring Nocturnal-Home Blood Pressure Monitoring Ambulatory Blood Pressure Monitoring

Also known as: Microlife WatchBP Home Nocturnal, Microlife WatchBP O3
All patients

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients referred for high blood pressure
  • Age over 30 years
  • Untreated for hypertension or under stable treatment for 4 weeks or more
  • Patients physically and mentally capable for self-measurement of blood pressure at home
  • Written informed consent to participate in the study

You may not qualify if:

  • Sustained arrythmia
  • Pregnancy
  • Symptomatic cardiovascular disease
  • Any other serious disease (renal failure, heart failure, malignancy)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sotiria General Hospital

Athens, 11527, Greece

Location

MeSH Terms

Conditions

Hypertension

Interventions

Blood Pressure Monitors

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

SphygmomanometersDiagnostic EquipmentEquipment and Supplies

Results Point of Contact

Title
George S. Stergiou
Organization
Hypertension Center, Third University Department of Medicine
gstergi@med.uoa.gr
0030 210 7763117

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine and Hypertension

Study Record Dates

First Submitted

October 25, 2011

First Posted

October 27, 2011

Study Start

November 1, 2010

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

July 10, 2012

Results First Posted

June 12, 2012

Record last verified: 2012-07

Locations

GR(1)