Trial document




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  DRKS00013607

Trial Description

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Title

THE EUROPEAN STUDY OF OLDER SUBJECTS WITH ATRIAL FIBRILLATION

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Trial Acronym

EUROSAF

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URL of the Trial

http://www.eurosaf.eu

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

Preliminary data suggest that:

1. a different risk of mortality, as assessed by the Multidimensional Prognostic Indices (MPI), may influence the anticoagulant prescription in older subjects with Atrial Fibrillation (AF);
2. the presence of multidimensional impairment, disability and multi-morbidities are usually not included in the decision algorithm of the more appropriate treatments in older patients with AF;
3. considering the prognostic information, as calculated by the MPI, can be useful to physicians in identifying older patients with AF that can benefit from anticoagulant treatment in term of increased survival.

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Organizational Data

  •   DRKS00013607
  •   2019/02/07
  •   2016/11/28
  •   yes
  •   Approved
  •   17- 100, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

  •   NCT02973984  (ClinicalTrials.gov)
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Health Condition or Problem studied

  •   I48.0 -  Paroxysmal atrial fibrillation
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Interventions/Observational Groups

  •   Hospitalized patients (>65 years) with atrial fibrillation undergo a CGA based MPI (Multidimensional Prognostic Index) and will be contacted via phone calls after 6 and 12 months to evaluate survival/mortality, hospital re -admissions, any haemorragic events, any thromboembolic events and compliance to the oral anticoagulant treatment.


    UPDATE MPIOH (MPI Oral Health):
    A subgroup of patients recruited for EUROSAF (100 patients during 12/2017 until 03/2019) undergoes several oral health assessments (OHA): 1. BOHSE (Kayser Jones Brief Oral Health Status Examination), 2. DMFT (Decayed, Missing, Filled Teeth Index). After 6 and 12 months the patients get phone calls to address oral health status and use of dental treatment.
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Prognosis
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

1) 6 and 12 months all-cause mortality and vascular mortality. Vascular mortality is defined as: stroke, embolism, myocardial infarction
2) thromboembolic events, defined as: stroke and/or systemic embolism
3) bleeding side-effects, defined as: major intracranial and gastrointestinal bleeding

(MPIOH: Oral Health Assessments:BOHSE, DMFT and GOHAI)

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Secondary Outcome

1. vascular-related hospitalization rates: stroke and/or systemic embolism
2. bleeding-related hospitalization rates: intracranial and gastrointestinal bleeding
3. MPI value and different mortality risk class (mild, moderate, severe)
4. presence/absence of anticoagulant treatments

(MPIOH: 1. Incidence of oral health diseases 2. Satisfaction concerning dentures 3. Use of dental treatment)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/07/01
  •   200
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   65   Years
  •   no maximum age
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Additional Inclusion Criteria

1. patients of both genders, aged 65 years and older
2. admitted to hospital for acute diseases or a relapse of chronic diseases
3. documented diagnosis of non valvular AF
4. informed consent

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Exclusion Criteria

1. age less than 65 years
2. no informed consent
3. poor german language skills

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Addresses

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    • Dipartimento: area delle cure geriatriche, ortogeriatria e riabilitazione - E.O. Ospedali Galliera - Genova Italy
    • Mr.  MD  Alberto  Pilotto 
    • 16128  Genova
    • Italy
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    • Klinik II für Innere Medizin, Klinische Altersforschung, Universitätsklinik Köln
    • Ms.  Prof. Dr. Dr.  Maria Cristina  Pollidori 
    • Kerpener Straße 62
    • 50937  Köln
    • Germany
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    • Klinik II für Innere Medizin, Klinische Altersforschung, Universitätsklinik Köln
    • Mr.  Joshua  Verleysdonk 
    • Kerpener Straße 62
    • 50937  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Dipartimento: area delle cure geriatriche, ortogeriatria e riabilitazione - E.O. Ospedali Galliera - Genova Italy
    • Mr.  MD  Alberto  Pilotto 
    • 16128  Genova
    • Italy
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    • Bayer AG
    • 51368  Leverkusen
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.