Atrial FibrillationNCT01088269
Blood Pressure Assessment in Atrial Fibrillation
An observational study of Atrial Fibrillation, run by University of Athens at 1 site in Greece.
Trial summary
This is a cross-sectional study including patients with permanent atrial fibrillation. Assessment will include: clinic blood pressure measurements (mercury sphygmomanometer and automated oscillometric device) 24-hour ambulatory blood pressure monitoring determination of various serum markers and cardiac ultrasound. Read more about this study
- Who is it for?
- Ages 25 to 85 years
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- Mar 2010to Dec 2017
- 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 25 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: SUBJECTS REFERRED TO HYPERTENSION CENTER
Who may be able to join
- Hypertensives adults in atrial fibrillation
Who cannot join
- Renal disease (Cr > 2 mg/l).
- Patients with pacemaker rhythm during the study.
- Each patient with acute disease (inflammation, surgery), malignancy, collagen diseases, pulmonary fibrosis, renal failure, liver failure, chronic inflammatory diseases.
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Hypertension Center, Third Internal Medicine Dpt, University of Athens
Athens
George S. Stergiou, 00302107763117, gstergi@med.uoa.gr
George S. Stergiou, Professor, 00302017763117, gstergi@med.uoa.gr
About this study
Official title: Evaluation of the Oscillometric Blood Pressure Measurement in Atrial Fibrillation and Relation of Blood Pressure With Serum Biomarkers and Echocardiographic Indexes
This is a cross-sectional study including patients with permanent atrial fibrillation. Assessment will include:
- clinic blood pressure measurements (mercury sphygmomanometer and automated oscillometric device)
- 24-hour ambulatory blood pressure monitoring
- determination of various serum markers and cardiac ultrasound.
- evaluation of a 24h ambulatory blood pressure monitoring device (Microlife WatchBPO3) in terms of its diagnostic value for the detection of atrial fibrillation compared with the reference 24h Holter ECG
- Conditions
- Atrial Fibrillation
- Keywords
- Blood Pressure Measurement, Atrial Fibrillation, Blood pressure measurement in atrial fibrillation, Atrial Fibrillation diagnosis
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| AF | Hypertensive patients in AF | |
| Non-AF | Hypertensive Patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure Measurement in Atrial Fibrillation,Serum Markers and echocardiographic indexes in atrial fibrillation (AF)
- Evaluation of the oscillometric technique of an electronic device in blood pressure measurement.
- Evaluation of the relationship of blood pressure levels with serum markers and ultrasonographic cardiac indexes.
- Evaluation of a 24h ambulatory blood pressure monitoring device (Microlife WatchBPO3) in terms of its diagnostic value for the detection of atrial fibrillation compared with the reference 24h Holter ECG
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, George S. Stergiou, University of Athens
- Investigators
- George S Stergiou, MD, Study chair, Hypertension Center,Third Department of Medicine,University of Athens,Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01088269
- Sponsor's protocol ID
- BPM IN AF
- Status last verified
- Sep 2017
- First submitted
- 16 Mar 2010
- Last updated
- 14 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Oscillometric Blood Pressure Measurement in Atrial Fibrillation and Relation of Blood Pressure With Serum Biomarkers and Echocardiographic Indexes
- ClinicalTrials.gov ID
- NCT01088269
- Acronym / sponsor ID
- BPM IN AF
- Conditions
- Atrial Fibrillation
- Keywords
- Blood Pressure Measurement, Atrial Fibrillation, Blood pressure measurement in atrial fibrillation, Atrial Fibrillation diagnosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of AthensUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 17 Mar 2010 (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.
This is a cross-sectional study including patients with permanent atrial fibrillation. Assessment will include:
- clinic blood pressure measurements (mercury sphygmomanometer and automated oscillometric device)
- 24-hour ambulatory blood pressure monitoring
- determination of various serum markers and cardiac ultrasound.
- evaluation of a 24h ambulatory blood pressure monitoring device (Microlife WatchBPO3) in terms of its diagnostic value for the detection of atrial fibrillation compared with the reference 24h Holter ECG
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AF | – | –Hypertensive patients in AF |
| Non-AF | – | –Hypertensive Patients |
Who may qualify
- Ages
- 25 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- SUBJECTS REFERRED TO HYPERTENSION CENTER
Key inclusion criteria (1 listed)
- Hypertensives adults in atrial fibrillation
Key exclusion criteria (3 listed)
- Renal disease (Cr > 2 mg/l).
- Patients with pacemaker rhythm during the study.
- Each patient with acute disease (inflammation, surgery), malignancy, collagen diseases, pulmonary fibrosis, renal failure, liver failure, chronic inflammatory diseases.
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
Blood Pressure Measurement in Atrial Fibrillation,Serum Markers and echocardiographic indexes in atrial fibrillation (AF)
Time frame: Baseline
1. Evaluation of the oscillometric technique of an electronic device in blood pressure measurement. 2. Evaluation of the relationship of blood pressure levels with serum markers and ultrasonographic cardiac indexes. 3. Evaluation of a 24h ambulatory blood pressure monitoring device (Microlife WatchBPO3) in terms of its diagnostic value for the detection of atrial fibrillation compared with the reference 24h Holter ECG
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2017.
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Atrial Fibrillation (AF)
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 Atrial Fibrillation, 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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 14 Sep 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact George S Stergiou, MD (+302107763117, gstergi@med.uoa.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure Measurement in Atrial Fibrillation,Serum Markers and echocardiographic indexes in atrial fibrillation (AF) (time frame: Baseline). It is what the study was designed to measure, not a finding.
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 14 Sep 2017.