Blood PressureNCT01029860
The Impact of Hospitalization on Ambulatory Blood Pressure and Intraocular Pressure
An observational study of Blood Pressure, run by Aristotle University Of Thessaloniki.
Trial summary
The purpose of this study is to assess the effect of hospital admission on 24-hour ambulatory blood pressure (ABP) in hypertensive subjects.Treated or untreated hypertensive adults with open angle glaucoma underwent in-hospital and outpatient 24-hour ABP monitoring, in random order 4 weeks apart. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Blood Pressure
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Mar 2007to Mar 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with untreated ocular hypertension and stage 1 arterial hypertension with or without treatment with anti-hypertensive agents.
Who may be able to join
- age >30 years old.
- subject has signed an informed consent.
- patient has untreated ocular hypertension (IOP at 10:00 between 22-34 mm Hg)
- patient has stage 1 arterial hypertension with or without therapy
Who cannot join
- secondary hypertension.
- stage 2 or 3 hypertension, history of renal disease.
- sleep apnea.
- diabetes mellitus
- acute or chronic inflammation.
- myocardial infarction or unstable angina within the past 6 months.
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- heart failure NYHA class III-IV.
- active liver disease.
- pregnancy.
- history of drug or alcohol abuse, or any other condition with poor prognosis.
- treatment with non-steroid anti-inflammatory agents, corticosteroids, beta-blockers, or any other regimen that could affect BP levels.
- smoking
About this study
Official title: A Study Investigating the Impact of Hospitalization on Ambulatory Blood Pressure and Intraocular Pressure in Subjects With Mild to Moderate Arterial Hypertension and Untreated Ocular Hypertension
The purpose of this study is to assess the effect of hospital admission on 24-hour ambulatory blood pressure (ABP) in hypertensive subjects.Treated or untreated hypertensive adults with open angle glaucoma underwent in-hospital and outpatient 24-hour ABP monitoring, in random order 4 weeks apart.
- Conditions
- Blood Pressure
- Keywords
- Hypertension, Ambulatory measurement
- Medical subject headings
- Hypertension
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2009 (estimated)
- Study startMar 2007
- Primary completionJan 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- 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 crossover
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01029860
- Sponsor's protocol ID
- A3244
- Status last verified
- Mar 2007
- First submitted
- 9 Dec 2009
- Last updated
- 17 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Investigating the Impact of Hospitalization on Ambulatory Blood Pressure and Intraocular Pressure in Subjects With Mild to Moderate Arterial Hypertension and Untreated Ocular Hypertension
- ClinicalTrials.gov ID
- NCT01029860
- Acronym / sponsor ID
- A3244
- Conditions
- Blood Pressure
- Keywords
- Hypertension, Ambulatory measurement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 10 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the effect of hospital admission on 24-hour ambulatory blood pressure (ABP) in hypertensive subjects.Treated or untreated hypertensive adults with open angle glaucoma underwent in-hospital and outpatient 24-hour ABP monitoring, in random order 4 weeks apart.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with untreated ocular hypertension and stage 1 arterial hypertension with or without treatment with anti-hypertensive agents.
Key inclusion criteria (4 listed)
- age >30 years old.
- subject has signed an informed consent.
- patient has untreated ocular hypertension (IOP at 10:00 between 22-34 mm Hg)
- patient has stage 1 arterial hypertension with or without therapy
Key exclusion criteria (12 listed)
- secondary hypertension.
- stage 2 or 3 hypertension, history of renal disease.
- sleep apnea.
- diabetes mellitus
- acute or chronic inflammation.
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Pressure, run by Aristotle University Of Thessaloniki.
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 4 inclusion and 12 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 17 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
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 17 Dec 2009.