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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 16, 2014