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Seasonal Variation of Ambulatory Blood Pressure

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
George S. Stergiou, University of Athens
ClinicalTrials.gov Identifier:
NCT01119755
First received: April 21, 2010
Last updated: December 8, 2011
Last verified: December 2011
History of Changes
  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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Athens:

Primary Outcome Measures:
  • Mean Difference of Systolic Daytime Ambulatory Blood Pressure Between Summer and Winter. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean Difference of Systolic Clinic Blood Pressure Between Summer and Winter [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Mean Difference of Diastolic Clinic Blood Pressure Between Summer and Winter [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Mean Difference of Systolic Home Blood Pressure Between Summer and Winter [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Mean Difference of Diastolic Home Blood Pressure Between Summer and Winter [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: George S. Stergiou, Professor of Medicine, University of Athens
ClinicalTrials.gov Identifier: NCT01119755     History of Changes
Other Study ID Numbers: SV
Study First Received: April 21, 2010
Results First Received: December 8, 2011
Last Updated: December 8, 2011
Health Authority: Greece: Ethics Committee

Keywords provided by University of Athens:
TREATMENT OF HYPERTENSION

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013