- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01119755
Seasonal Variation of Ambulatory Blood Pressure
December 8, 2011 updated by: George S. Stergiou, University of Athens
Seasonal Variation of 24hour Ambulatory Blood Pressure Monitoring in Treated Hypertensives
This is a prospective study to evaluate the change in 24 hour ambulatory blood pressure during winter and summer in well controlled treated hypertensives.
Study Overview
Status
Completed
Conditions
Detailed Description
Two 24hour ambulatory blood pressure monitorings, 4 to 6 months apart, will be performed on hypertensive subjects on a stable antihypertensive drug therapy for at least 4 weeks.
The correlation of weather and temperature with the 24hour ambulatory blood pressure monitoring will be explored.
Study Type
Observational
Enrollment (Actual)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Athens, Greece
- Hypertension Center, Third Department of Medicine, University of Athens, Greece
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
36 years to 76 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
TREATED HYPERTENSIVES REFERRED TO AN OUTPATIENT CLINIC
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Congestive heart failure
- Use of loop diuretics
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean Difference of Systolic Daytime Ambulatory Blood Pressure Between Summer and Winter.
Time Frame: 1 year
|
Mean difference of systolic daytime ambulatory blood pressure measurement during summer and winter period
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1 year
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Mean Difference of Diastolic Daytime Ambulatory Blood Pressure Between Summer and Winter
Time Frame: 1 year
|
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
Time Frame: 1 year
|
Mean difference of systolic night-time ambulatory blood pressure measurement during summer and winter period
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1 year
|
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Mean Difference of Diastolic Night-time Ambulatory Blood Pressure Between Summer and Winter
Time Frame: 1 year
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1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Mean Difference of Systolic Clinic Blood Pressure Between Summer and Winter
Time Frame: 1 year
|
1 year
|
|
Mean Difference of Diastolic Clinic Blood Pressure Between Summer and Winter
Time Frame: 1 year
|
1 year
|
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Mean Difference of Systolic Home Blood Pressure Between Summer and Winter
Time Frame: 1 year
|
1 year
|
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Mean Difference of Diastolic Home Blood Pressure Between Summer and Winter
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: George S Stergiou, MD, Hypertension Center,Third Department of Medicine,University of Athens,Greece
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Actual)
August 1, 2011
Study Completion (Actual)
August 1, 2011
Study Registration Dates
First Submitted
April 21, 2010
First Submitted That Met QC Criteria
May 6, 2010
First Posted (Estimate)
May 10, 2010
Study Record Updates
Last Update Posted (Estimate)
January 23, 2012
Last Update Submitted That Met QC Criteria
December 8, 2011
Last Verified
December 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SV
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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