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Seasonal Variation of Ambulatory Blood Pressure

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01119755
First Posted: May 10, 2010
Last Update Posted: January 23, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
George S. Stergiou, University of Athens
  Purpose
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
Hypertension

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Seasonal Variation of 24hour Ambulatory Blood Pressure Monitoring in Treated Hypertensives

Further study details as provided by George S. Stergiou, University of Athens:

Primary Outcome Measures:
  • 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

  • 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

  • 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

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

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

Enrollment: 80
Study Start Date: January 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
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
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
Greece
Hypertension Center, Third Department of Medicine, University of Athens, Greece
Athens, Greece
Sponsors and Collaborators
University of Athens
Investigators
Study Chair: George S Stergiou, MD Hypertension Center,Third Department of Medicine,University of Athens,Greece
  More Information

Responsible Party: George S. Stergiou, Professor of Medicine, University of Athens
ClinicalTrials.gov Identifier: NCT01119755     History of Changes
Other Study ID Numbers: SV
First Submitted: April 21, 2010
First Posted: May 10, 2010
Results First Submitted: December 8, 2011
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:
Hypertension
Vascular Diseases
Cardiovascular Diseases