HypertensionNCT01119755

Seasonal Variation of Ambulatory Blood Pressure

An observational study of Hypertension, run by University of Athens at 1 site in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 40 to 80 years
Conditions the study is for: Hypertension
How many people: 80 participants
Where: 1 siteGreece
Study dates: Jan 2010to Aug 2011
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: TREATED HYPERTENSIVES REFERRED TO AN OUTPATIENT CLINIC

Who may be able to join

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

Who cannot join

Congestive heart failure
Use of loop diuretics

Trial locations and contacts

1 site in 1 country.

Greece1 site

Hypertension Center, Third Department of Medicine, University of Athens, Greece
Athens

Other trials in Greece

About this study

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

This is a prospective study to evaluate the change in 24 hour ambulatory blood pressure during winter and summer in well controlled treated hypertensives.

Read the 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.

Conditions: Hypertension
Keywords: TREATMENT OF HYPERTENSION
Medical subject headings: Hypertension

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 1 year
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
Measured: 1 year
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
Measured: 1 year
Mean Difference of Diastolic Night-time Ambulatory Blood Pressure Between Summer and Winter
Measured: 1 year

Secondary outcomes (4)

Mean Difference of Systolic Clinic Blood Pressure Between Summer and Winter
Measured: 1 year
Mean Difference of Diastolic Clinic Blood Pressure Between Summer and Winter
Measured: 1 year
Mean Difference of Systolic Home Blood Pressure Between Summer and Winter
Measured: 1 year
Mean Difference of Diastolic Home Blood Pressure Between Summer and Winter
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2010Aug 2011

First posted10 May 2010 (estimated)
Study startJan 2010
Primary completionAug 2011
Study completionAug 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HypertensionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01119755
Sponsor's protocol ID: SV
Status last verified: Dec 2011
First submitted: 21 Apr 2010
Last updated: 23 Jan 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Seasonal Variation of 24hour Ambulatory Blood Pressure Monitoring in Treated Hypertensives
ClinicalTrials.gov ID: NCT01119755
Acronym / sponsor ID: SV
Conditions: Hypertension
Keywords: TREATMENT OF HYPERTENSION
Study type: Observational
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: University of AthensUniversity, hospital or other
Study start: Jan 2010
Primary completion: Aug 2011 (actual)
Study completion: Aug 2011 (actual)
First posted: 10 May 2010 (estimated)
Results: Posted 23 Jan 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Observational model: Case only
Time perspective: Prospective

Who may qualify

Ages: 40 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: TREATED HYPERTENSIVES REFERRED TO AN OUTPATIENT CLINIC

Key inclusion criteria (3 listed)

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

Key exclusion criteria (2 listed)

Congestive heart failure
Use of loop diuretics

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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

4 secondary outcomes

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

Results and safety

Results posted to the registry on 23 Jan 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1	80	80

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

Time frame: 1 year. Mean (Standard Deviation). Unit: mmHg

Measure	Group 1 n = 80
Value	7.7 (14)

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

Time frame: 1 year. Mean (Standard Deviation). Unit: mmHg

Measure	Group 1 n = 80
Value	4.1 (10)

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

Time frame: 1 year. Mean (Standard Deviation). Unit: mmHg

Measure	Group 1 n = 80
Value	-0.1 (11.2)

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

Time frame: 1 year. Mean (Standard Deviation). Unit: mmHg

Measure	Group 1 n = 80
Value	0.6 (8.9)

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1	0 of 80 (0%)	0 of 80 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hypertension

Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

George S Stergiou, MD study chair

Hypertension Center,Third Department of Medicine,University of Athens,Greece

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Hypertension, run by University of Athens at 1 site in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jan 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Difference of Systolic Daytime Ambulatory Blood Pressure Between Summer and Winter. (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01119755.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2012.