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Blood Pressure Assessment in Atrial Fibrillation

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ClinicalTrials.gov Identifier: NCT01088269
Recruitment Status : Recruiting
First Posted : March 17, 2010
Last Update Posted : September 14, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.
  • 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

Condition or disease
Atrial Fibrillation

Study Design

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Evaluation of the Oscillometric Blood Pressure Measurement in Atrial Fibrillation and Relation of Blood Pressure With Serum Biomarkers and Echocardiographic Indexes
Study Start Date : March 2010
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
AF
Hypertensive patients in AF
Non-AF
Hypertensive Patients


Outcome Measures

Primary Outcome Measures :
  1. 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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
SUBJECTS REFERRED TO HYPERTENSION CENTER
Criteria

Inclusion Criteria:

  • Hypertensives adults in atrial fibrillation

Exclusion Criteria:

  • 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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01088269


Contacts
Contact: George S Stergiou, MD +302107763117 gstergi@med.uoa.gr

Locations
Greece
Hypertension Center, Third Internal Medicine Dpt, University of Athens Recruiting
Athens, Greece
Contact: George S. Stergiou    00302107763117    gstergi@med.uoa.gr   
Contact: George S. Stergiou, Professor    00302017763117    gstergi@med.uoa.gr   
Sub-Investigator: Antonios Th. Destounis, Phd candidate         
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

Responsible Party: George S. Stergiou, Associate Professor of Medicine and Hypertension, University of Athens
ClinicalTrials.gov Identifier: NCT01088269     History of Changes
Other Study ID Numbers: BPM IN AF
First Posted: March 17, 2010    Key Record Dates
Last Update Posted: September 14, 2017
Last Verified: September 2017

Keywords provided by George S. Stergiou, University of Athens:
Blood Pressure Measurement
Atrial Fibrillation
Blood pressure measurement in atrial fibrillation
Atrial Fibrillation diagnosis

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes