Skip to main content
OpenTrials
Completed

NCT Number: NCT01317602

Current Clinical Practice in the Management of Atrial Fibrillation in Greece: the MANAGE-AF Study

This is a multicenter, 1-year prospective, observational study of Atrial Fibrillation (AF) in Greece, designed to provide real world data regarding the characteristics of AF patients in Greece, as well as current clinical practices and adherence to the 2010 ESC guidelines.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Alexandroupoli, Alexandroupoli, Greece

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged ≥ 18 years with any type of AF(first diagnosed, paroxysmal, persistent, long-standing persistent and permanent) according to the classification described in the recent ESC guidelines.
  • All patients should give written informed consent to participate in the study.

Exclusion criteria

  • Patients anticipated life expectancy less than 1 year due to a severe concomitant disease.
  • Participation in an another clinical trial, with the exception of epidemiology trials (observational) that do not influence AF management.
  • Patients with mental disability unable to comply with follow - up visits and these who are unable to provide, in written, their informed consent or patients with anticipated inability to adhere to scheduled follow up visits.

Treatment and study plan

Primary outcomes

  1. Evaluation of the management of patients with Atrial Fibrillation.

    Time frame: 1 year

    Evaluation of the use of anticoagulants and antithrombotic drugs. Evaluation of the doctors' compliance with the guidelines.

Secondary outcomes

  1. Evaluation of the risk of strokes.

    Time frame: Baseline-6month-12months

    Evaluation of the risk in a large number of patients using the CHA2DS2-VASc and HAS-BLED scores.

  2. Assessment of morbidity and mortality of patients with AF.

    Time frame: 1 year

    Assessment of morbidity and mortality of patients with AFduring one year follow-up in comparison with previous results from other registries.

  3. Assessment of the compliance of patients to treatment.

    Time frame: Baseline-6months-12months

    Evaluation of the compliance of patients to treatment and the frequency of visits to their physician especially in terms of achieving therapeutic target INR (TTR, Time in Therapeutic Range).

  4. Assessment of the awareness of patients about the Atrial Fibrillation.

    Time frame: Baseline

    Assessment of the awareness of patients about the Atrial Fibrilation and the potential risk of AF.

  5. Assessment of patients' quality of life.

    Time frame: Baseline-6months-12months

    Assessment of patients' quality of life (QoL) using a specific questionnaire (EQ - 5D, http://www.euroqol.org) and EHRA score for evaluation of symptoms.

Sponsors and collaborators

Lead sponsor

Hellenic Cardiovascular Research Society

Other

Collaborators

  • Bayer

Registry information

Acronym: MANAGE-AF

Important dates

Study start
2011
Primary completion
2011
First posted
Mar 17, 2011
Registry last updated
Apr 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.