NCT01088269

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

March 16, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 17, 2010

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

September 14, 2017

Status Verified

September 1, 2017

Enrollment Period

7.8 years

First QC Date

March 16, 2010

Last Update Submit

September 13, 2017

Conditions

Keywords

Blood Pressure MeasurementAtrial FibrillationBlood pressure measurement in atrial fibrillationAtrial Fibrillation diagnosis

Outcome Measures

Primary Outcomes (1)

  • Blood Pressure Measurement in Atrial Fibrillation,Serum Markers and echocardiographic indexes in atrial fibrillation (AF)

    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

    Baseline

Study Arms (2)

AF

Hypertensive patients in AF

Non-AF

Hypertensive Patients

Eligibility Criteria

Age25 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

SUBJECTS REFERRED TO HYPERTENSION CENTER

You may qualify if:

  • Hypertensives adults in atrial fibrillation

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hypertension Center, Third Internal Medicine Dpt, University of Athens

Athens, Greece

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • George S Stergiou, MD

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

    STUDY CHAIR

Central Study Contacts

George S Stergiou, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine and Hypertension

Study Record Dates

First Submitted

March 16, 2010

First Posted

March 17, 2010

Study Start

March 1, 2010

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

September 14, 2017

Record last verified: 2017-09

Locations