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Seasonal Variation of Ambulatory Blood Pressure

Seasonal Variation of 24hour Ambulatory Blood Pressure Monitoring in Treated Hypertensives

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01119755
Enrollment
80
Registered
2010-05-10
Start date
2010-01-31
Completion date
2011-08-31
Last updated
2012-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

TREATMENT OF HYPERTENSION

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.

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.

Interventions

None listed

Sponsors

University of Athens
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mean Difference of Diastolic Night-time Ambulatory Blood Pressure Between Summer and Winter1 year—
Mean Difference of Systolic Daytime Ambulatory Blood Pressure Between Summer and Winter.1 yearMean difference of systolic daytime ambulatory blood pressure measurement during summer and winter period
Mean Difference of Diastolic Daytime Ambulatory Blood Pressure Between Summer and Winter1 yearMean 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 Winter1 yearMean difference of systolic night-time ambulatory blood pressure measurement during summer and winter period

Secondary

MeasureTime frame
Mean Difference of Systolic Clinic Blood Pressure Between Summer and Winter1 year
Mean Difference of Diastolic Clinic Blood Pressure Between Summer and Winter1 year
Mean Difference of Systolic Home Blood Pressure Between Summer and Winter1 year
Mean Difference of Diastolic Home Blood Pressure Between Summer and Winter1 year

Countries

Greece

Participant flow

Participants by arm

ArmCount
Group 180
Total80

Baseline characteristics

CharacteristicGroup 1
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
37 Participants
Age, Categorical
Between 18 and 65 years
43 Participants
Age Continuous64 years
STANDARD_DEVIATION 8.8
Region of Enrollment
Greece
80 participants
Sex: Female, Male
Female
31 Participants
Sex: Female, Male
Male
49 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 80
serious
Total, serious adverse events
0 / 80

Outcome results

Primary

Mean Difference of Diastolic Daytime Ambulatory Blood Pressure Between Summer and Winter

Mean Difference of Diastolic Daytime Ambulatory Blood Pressure Measurement During Summer and Winter Period

Time frame: 1 year

ArmMeasureValue (MEAN)Dispersion
Group 1Mean Difference of Diastolic Daytime Ambulatory Blood Pressure Between Summer and Winter4.1 mmHgStandard Deviation 10
Primary

Mean Difference of Diastolic Night-time Ambulatory Blood Pressure Between Summer and Winter

Time frame: 1 year

ArmMeasureValue (MEAN)Dispersion
Group 1Mean Difference of Diastolic Night-time Ambulatory Blood Pressure Between Summer and Winter0.6 mmHgStandard Deviation 8.9
Primary

Mean Difference of Systolic Daytime Ambulatory Blood Pressure Between Summer and Winter.

Mean difference of systolic daytime ambulatory blood pressure measurement during summer and winter period

Time frame: 1 year

ArmMeasureValue (MEAN)Dispersion
Group 1Mean Difference of Systolic Daytime Ambulatory Blood Pressure Between Summer and Winter.7.7 mmHgStandard Deviation 14
Primary

Mean Difference of Systolic Night-time Ambulatory Blood Pressure Between Summer and Winter

Mean difference of systolic night-time ambulatory blood pressure measurement during summer and winter period

Time frame: 1 year

ArmMeasureValue (MEAN)Dispersion
Group 1Mean Difference of Systolic Night-time Ambulatory Blood Pressure Between Summer and Winter-0.1 mmHgStandard Deviation 11.2
Secondary

Mean Difference of Diastolic Clinic Blood Pressure Between Summer and Winter

Time frame: 1 year

ArmMeasureValue (MEAN)Dispersion
Group 1Mean Difference of Diastolic Clinic Blood Pressure Between Summer and Winter2.7 mmHgStandard Deviation 7
Secondary

Mean Difference of Diastolic Home Blood Pressure Between Summer and Winter

Time frame: 1 year

ArmMeasureValue (MEAN)Dispersion
Group 1Mean Difference of Diastolic Home Blood Pressure Between Summer and Winter2.7 mmHgStandard Deviation 4.1
Secondary

Mean Difference of Systolic Clinic Blood Pressure Between Summer and Winter

Time frame: 1 year

ArmMeasureValue (MEAN)Dispersion
Group 1Mean Difference of Systolic Clinic Blood Pressure Between Summer and Winter7.5 mmHgStandard Deviation 11.1
Secondary

Mean Difference of Systolic Home Blood Pressure Between Summer and Winter

Time frame: 1 year

ArmMeasureValue (MEAN)Dispersion
Group 1Mean Difference of Systolic Home Blood Pressure Between Summer and Winter3.2 mmHgStandard Deviation 14

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026