The European Registry of Older Subjects With Atrial Fibrillation (EUROSAF)

NCT02973984 | Unknown DMC

• 2 other identifiers: 28UCS2015162REG2016
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

Preliminary data suggest that:

1. 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. 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. 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.

Conditions

Atrial Fibrillation

Keywords

Anticoagulant Treatments; Multidimensional Prognostic Index (MPI); Comprehensive Geriatric Assessment (CGA); Frailty; Elderly; Atrial Fibrillation

Outcome Measures

Primary Outcomes (3)

• all-cause mortality and vascular mortality

  Vascular mortality is defined as: stroke, embolism, myocardial infarction

  12 months

• thromboembolic events,

  stroke and/or systemic embolism

  12 months

• bleeding side-effects

  major intracranial and gastrointestinal bleeding.

  12 months

Secondary Outcomes (4)

• vascular-related hospitalization rates

  12 months

• bleeding-related hospitalization rates

  12 months

• MPI value and different mortality risk class

  12 months

• presence/absence of anticoagulant treatments

  12 months

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a cross-national, prospective, observational study that will include about 3.000 older subjects (aged ≥ 65 years) with AF hospitalized in 30 European geriatric centers (about 100 subjects/center) for an acute disease or a relapse of a chronic diseases. The study is in the frame of the Special Interest Group on CGA (Comprehensive Geriatric Assessment) of the EUGMS (European Union Geriatric Medicine Society).

You may qualify if:

• patients of both genders, aged 65 years and older
• admitted to hospital for acute diseases or a relapse of chronic diseases
• with a documented diagnosis of non valvular AF
• who are willing to participate in the survey and give their informed consent

You may not qualify if:

• age less than 65 years
• patients who have not provided informed consent

Sponsors & Collaborators

• Alberto Pilotto: lead
• Bayer: collaborator

Study Sites (1)

S.C. Geriatria

Genova, 16128, Italy

RECRUITING

Related Publications (26)

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  PMID: 23558044 BACKGROUND

• Camm AJ, Kirchhof P, Lip GY, Schotten U, Savelieva I, Ernst S, Van Gelder IC, Al-Attar N, Hindricks G, Prendergast B, Heidbuchel H, Alfieri O, Angelini A, Atar D, Colonna P, De Caterina R, De Sutter J, Goette A, Gorenek B, Heldal M, Hohloser SH, Kolh P, Le Heuzey JY, Ponikowski P, Rutten FH; ESC Committee for Practice Guidelines. Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC). Europace. 2010 Oct;12(10):1360-420. doi: 10.1093/europace/euq350. No abstract available.

  PMID: 20876603 BACKGROUND

• Hylek EM, D'Antonio J, Evans-Molina C, Shea C, Henault LE, Regan S. Translating the results of randomized trials into clinical practice: the challenge of warfarin candidacy among hospitalized elderly patients with atrial fibrillation. Stroke. 2006 Apr;37(4):1075-80. doi: 10.1161/01.STR.0000209239.71702.ce. Epub 2006 Mar 9.

  PMID: 16527999 BACKGROUND

• Pugh D, Pugh J, Mead GE. Attitudes of physicians regarding anticoagulation for atrial fibrillation: a systematic review. Age Ageing. 2011 Nov;40(6):675-83. doi: 10.1093/ageing/afr097. Epub 2011 Aug 5.

  PMID: 21821732 BACKGROUND

• Maes F, Dalleur O, Henrard S, Wouters D, Scavee C, Spinewine A, Boland B. Risk scores and geriatric profile: can they really help us in anticoagulation decision making among older patients suffering from atrial fibrillation? Clin Interv Aging. 2014 Jul 15;9:1091-9. doi: 10.2147/CIA.S62597. eCollection 2014.

  PMID: 25053883 BACKGROUND

• Sinnaeve PR, Brueckmann M, Clemens A, Oldgren J, Eikelboom J, Healey JS. Stroke prevention in elderly patients with atrial fibrillation: challenges for anticoagulation. J Intern Med. 2012 Jan;271(1):15-24. doi: 10.1111/j.1365-2796.2011.02464.x. Epub 2011 Oct 31.

  PMID: 21995885 BACKGROUND

• Zarraga IG, Kron J. Oral anticoagulation in elderly adults with atrial fibrillation: integrating new options with old concepts. J Am Geriatr Soc. 2013 Jan;61(1):143-50. doi: 10.1111/jgs.12042. Epub 2012 Dec 18.

  PMID: 23252345 BACKGROUND

• Barco S, Cheung YW, Eikelboom JW, Coppens M. New oral anticoagulants in elderly patients. Best Pract Res Clin Haematol. 2013 Jun;26(2):215-24. doi: 10.1016/j.beha.2013.07.011. Epub 2013 Jul 21.

  PMID: 23953909 BACKGROUND

• Sardar P, Chatterjee S, Chaudhari S, Lip GY. New oral anticoagulants in elderly adults: evidence from a meta-analysis of randomized trials. J Am Geriatr Soc. 2014 May;62(5):857-64. doi: 10.1111/jgs.12799. Epub 2014 May 1.

  PMID: 24786913 BACKGROUND

• Stollberger C, Finsterer J. Concerns about the use of new oral anticoagulants for stroke prevention in elderly patients with atrial fibrillation. Drugs Aging. 2013 Dec;30(12):949-58. doi: 10.1007/s40266-013-0119-3.

  PMID: 24170233 BACKGROUND

• Crome P, Lally F, Cherubini A, Oristrell J, Beswick AD, Clarfield AM, Hertogh C, Lesauskaite V, Prada GI, Szczerbinska K, Topinkova E, Sinclair-Cohen J, Edbrooke D, Mills G. Exclusion of older people from clinical trials: professional views from nine European countries participating in the PREDICT study. Drugs Aging. 2011 Aug 1;28(8):667-77. doi: 10.2165/11591990-000000000-00000.

  PMID: 21812501 BACKGROUND

• Gill TM. The central role of prognosis in clinical decision making. JAMA. 2012 Jan 11;307(2):199-200. doi: 10.1001/jama.2011.1992. No abstract available.

  PMID: 22235093 BACKGROUND

• Pilotto A, Ferrucci L, Franceschi M, D'Ambrosio LP, Scarcelli C, Cascavilla L, Paris F, Placentino G, Seripa D, Dallapiccola B, Leandro G. Development and validation of a multidimensional prognostic index for one-year mortality from comprehensive geriatric assessment in hospitalized older patients. Rejuvenation Res. 2008 Feb;11(1):151-61. doi: 10.1089/rej.2007.0569.

  PMID: 18173367 BACKGROUND

• Pilotto A, Gallina P, Fontana A, Sancarlo D, Bazzano S, Copetti M, Maggi S, Paroni G, Marcato F, Pellegrini F, Donato D, Ferrucci L. Development and validation of a Multidimensional Prognostic Index for mortality based on a standardized Multidimensional Assessment Schedule (MPI-SVaMA) in community-dwelling older subjects. J Am Med Dir Assoc. 2013 Apr;14(4):287-92. doi: 10.1016/j.jamda.2013.01.005. Epub 2013 Feb 9.

  PMID: 23402948 BACKGROUND

• Siontis GC, Tzoulaki I, Ioannidis JP. Predicting death: an empirical evaluation of predictive tools for mortality. Arch Intern Med. 2011 Oct 24;171(19):1721-6. doi: 10.1001/archinternmed.2011.334. Epub 2011 Jul 25.

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• Yourman LC, Lee SJ, Schonberg MA, Widera EW, Smith AK. Prognostic indices for older adults: a systematic review. JAMA. 2012 Jan 11;307(2):182-92. doi: 10.1001/jama.2011.1966.

  PMID: 22235089 BACKGROUND

• Pilotto A, Rengo F, Marchionni N, Sancarlo D, Fontana A, Panza F, Ferrucci L; FIRI-SIGG Study Group. Comparing the prognostic accuracy for all-cause mortality of frailty instruments: a multicentre 1-year follow-up in hospitalized older patients. PLoS One. 2012;7(1):e29090. doi: 10.1371/journal.pone.0029090. Epub 2012 Jan 11.

  PMID: 22247767 BACKGROUND

• Volpato S, Bazzano S, Fontana A, Ferrucci L, Pilotto A; MPI-TriVeneto Study Group. Multidimensional Prognostic Index predicts mortality and length of stay during hospitalization in the older patients: a multicenter prospective study. J Gerontol A Biol Sci Med Sci. 2015 Mar;70(3):325-31. doi: 10.1093/gerona/glu167. Epub 2014 Sep 9.

  PMID: 25209253 BACKGROUND

• Pilotto A, Panza F, Ferrucci L. A multidimensional prognostic index in common conditions leading to death in older patients. Arch Intern Med. 2012 Apr 9;172(7):594; discussion 594-5. doi: 10.1001/archinternmed.2011.1891. No abstract available.

  PMID: 22493470 BACKGROUND

• Angleman SB, Santoni G, Pilotto A, Fratiglioni L, Welmer AK; MPI_AGE Project Investigators. Multidimensional Prognostic Index in Association with Future Mortality and Number of Hospital Days in a Population-Based Sample of Older Adults: Results of the EU Funded MPI_AGE Project. PLoS One. 2015 Jul 29;10(7):e0133789. doi: 10.1371/journal.pone.0133789. eCollection 2015.

  PMID: 26222546 BACKGROUND

• Cerreta F, Eichler HG, Rasi G. Drug policy for an aging population--the European Medicines Agency's geriatric medicines strategy. N Engl J Med. 2012 Nov 22;367(21):1972-4. doi: 10.1056/NEJMp1209034. No abstract available.

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• Granziera S, Cohen AT, Nante G, Manzato E, Sergi G. Thromboembolic prevention in frail elderly patients with atrial fibrillation: a practical algorithm. J Am Med Dir Assoc. 2015 May 1;16(5):358-64. doi: 10.1016/j.jamda.2014.12.008. Epub 2015 Feb 11.

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• Olesen JB, Lip GY, Hansen ML, Hansen PR, Tolstrup JS, Lindhardsen J, Selmer C, Ahlehoff O, Olsen AM, Gislason GH, Torp-Pedersen C. Validation of risk stratification schemes for predicting stroke and thromboembolism in patients with atrial fibrillation: nationwide cohort study. BMJ. 2011 Jan 31;342:d124. doi: 10.1136/bmj.d124.

  PMID: 21282258 BACKGROUND

• Pisters R, Lane DA, Nieuwlaat R, de Vos CB, Crijns HJ, Lip GY. A novel user-friendly score (HAS-BLED) to assess 1-year risk of major bleeding in patients with atrial fibrillation: the Euro Heart Survey. Chest. 2010 Nov;138(5):1093-100. doi: 10.1378/chest.10-0134. Epub 2010 Mar 18.

  PMID: 20299623 BACKGROUND

• Pilotto A, Veronese N, Polidori MC, Strandberg T, Topinkova E, Cruz-Jentoft AJ, Custodero C, Maggi S; EUROSAF Study Investigators. The role of prognostic stratification on prescription of anticoagulants in older patients with atrial fibrillation: a multicenter, observational, prospective European study (EUROSAF). Ann Med. 2022 Dec;54(1):2411-2419. doi: 10.1080/07853890.2022.2117407.

  PMID: 36062815 DERIVED

• Veronese N, Argusti A, Canepa E, Polidori MC, Maggi S, Strandberg T, Pilotto A; EUROSAF Study Investigators. Evaluating the effectiveness and risks of oral anticoagulant treatments in multimorbid frail older subjects with atrial fibrillation using the multidimensional prognostic index: the EURopean study of older subjects with atrial fibrillation-EUROSAF. Eur Geriatr Med. 2018 Apr;9(2):149-154. doi: 10.1007/s41999-018-0026-6. Epub 2018 Feb 27.

  PMID: 34654263 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Frailty

Condition Hierarchy (Ancestors)

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

Study Officials

• Alberto Pilotto, MD

  Dipartimento: area delle cure geriatriche, ortogeriatria e riabilitazione - E.O. Ospedali Galliera - Genova Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alberto Pilotto, MD

CONTACT

0039 010 563; alberto.pilotto@galliera.it

Alessandra Argusti, PDH

CONTACT

0039 010 563; a.argusti@galliera.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Department Geriatric Care, OrthoGeriatrics and Rehabilitation

Study Record Dates

• First Submitted: October 24, 2016
• First Posted: November 28, 2016
• Study Start: November 18, 2016
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 7, 2023

Record last verified: 2023-09

Locations

IT (1)