NCT01119755

Brief Summary

This is a prospective study to evaluate the change in 24 hour ambulatory blood pressure during winter and summer in well controlled treated hypertensives.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2010

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 10, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
6 months until next milestone

Results Posted

Study results publicly available

January 23, 2012

Completed
Last Updated

January 23, 2012

Status Verified

December 1, 2011

Enrollment Period

1.6 years

First QC Date

April 21, 2010

Results QC Date

December 8, 2011

Last Update Submit

December 8, 2011

Conditions

Keywords

TREATMENT OF HYPERTENSION

Outcome Measures

Primary Outcomes (4)

  • Mean Difference of Systolic Daytime Ambulatory Blood Pressure Between Summer and Winter.

    Mean difference of systolic daytime ambulatory blood pressure measurement during summer and winter period

    1 year

  • Mean Difference of Diastolic Daytime Ambulatory Blood Pressure Between Summer and Winter

    Mean Difference of Diastolic Daytime Ambulatory Blood Pressure Measurement During Summer and Winter Period

    1 year

  • Mean Difference of Systolic Night-time Ambulatory Blood Pressure Between Summer and Winter

    Mean difference of systolic night-time ambulatory blood pressure measurement during summer and winter period

    1 year

  • Mean Difference of Diastolic Night-time Ambulatory Blood Pressure Between Summer and Winter

    1 year

Secondary Outcomes (4)

  • Mean Difference of Systolic Clinic Blood Pressure Between Summer and Winter

    1 year

  • Mean Difference of Diastolic Clinic Blood Pressure Between Summer and Winter

    1 year

  • Mean Difference of Systolic Home Blood Pressure Between Summer and Winter

    1 year

  • Mean Difference of Diastolic Home Blood Pressure Between Summer and Winter

    1 year

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

TREATED HYPERTENSIVES REFERRED TO AN OUTPATIENT CLINIC

You may qualify if:

  • Age \> 40 yrs
  • Treated hypertension on stable treatment for at least 8 weeks
  • Average home blood pressure (at least 5 days, 20 readings) \< 130/80 mmHg

You may not qualify if:

  • Congestive heart failure
  • Use of loop diuretics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Athens, Greece

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
George S Stergiou, Associate Professor of Internal Medicine and Hypertension
Organization
Hypertension Center, Third Department of Medicine, University of Athens, Greece

Study Officials

  • George S Stergiou, MD

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

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

April 21, 2010

First Posted

May 10, 2010

Study Start

January 1, 2010

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

January 23, 2012

Results First Posted

January 23, 2012

Record last verified: 2011-12

Locations