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Seasonal Variation of Ambulatory Blood Pressure

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ClinicalTrials.gov Identifier: NCT01119755
Recruitment Status : Completed
First Posted : May 10, 2010
Results First Posted : January 23, 2012
Last Update Posted : January 23, 2012
Sponsor:
Information provided by (Responsible Party):
George S. Stergiou, University of Athens

Study Description
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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.

Condition or disease
Hypertension

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 Design
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Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Seasonal Variation of 24hour Ambulatory Blood Pressure Monitoring in Treated Hypertensives
Study Start Date : January 2010
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. Mean Difference of Diastolic Night-time Ambulatory Blood Pressure Between Summer and Winter [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Mean Difference of Systolic Clinic Blood Pressure Between Summer and Winter [ Time Frame: 1 year ]
  2. Mean Difference of Diastolic Clinic Blood Pressure Between Summer and Winter [ Time Frame: 1 year ]
  3. Mean Difference of Systolic Home Blood Pressure Between Summer and Winter [ Time Frame: 1 year ]
  4. Mean Difference of Diastolic Home Blood Pressure Between Summer and Winter [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
TREATED HYPERTENSIVES REFERRED TO AN OUTPATIENT CLINIC
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01119755


Locations
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Greece
Hypertension Center, Third Department of Medicine, University of Athens, Greece
Athens, Greece
Sponsors and Collaborators
University of Athens
Investigators
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Study Chair: George S Stergiou, MD Hypertension Center,Third Department of Medicine,University of Athens,Greece
More Information
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Responsible Party: George S. Stergiou, Professor of Medicine, University of Athens
ClinicalTrials.gov Identifier: NCT01119755    
Other Study ID Numbers: SV
First Posted: May 10, 2010    Key Record Dates
Results First Posted: January 23, 2012
Last Update Posted: January 23, 2012
Last Verified: December 2011
Keywords provided by George S. Stergiou, University of Athens:
TREATMENT OF HYPERTENSION
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases