Swiss Atrial Fibrillation Cohort Study (SWISS-AF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT02105844

Recruitment Status : Active, not recruiting

First Posted : April 7, 2014

Last Update Posted : May 24, 2022

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborators:

Swiss National Science Foundation

Medical Image Analysis Center (MIAC) Basel

Schiller AG Baar

Clinical Trial Unit, University Hospital Basel, Switzerland

Cardiovascular Research Institute (CRIB) Basel

Cardiocentro Ticino

Information provided by (Responsible Party):

University Hospital, Basel, Switzerland

Study Description

Brief Summary:

Swiss-AF is a prospective observational, multicentric cohort study in Switzerland. Overall, 2600 patients with documented atrial fibrillation aged >65 years will be included and followed on a yearly basis.

Yearly clinical examinations include a detailed questionnaire on personal characteristics, a resting electrocardiogram, neurocognitive function tests and questionnaires on disability and quality of life. Blood sampling and brain magnetic resonance imaging are scheduled at baseline and after 2 years of follow-up.

The main study aims of this long term prospective study are to increase our knowledge on structural brain damage and its changes over time in patients with atrial fibrillation, to gain additional insights on the incidence and underlying mechanisms of cognitive decline in patients with atrial fibrillation and to evaluate the interrelationships of structural and functional brain damage in this population.

Condition or disease
Atrial Fibrillation

Study Design

Layout table for study information

Study Type :	Observational
Actual Enrollment :	2415 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Swiss Atrial Fibrillation Cohort Study - SWISS AF
Actual Study Start Date :	March 2014
Estimated Primary Completion Date :	March 2030
Estimated Study Completion Date :	March 2030

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Familial atrial fibrillation

MedlinePlus related topics: Atrial Fibrillation

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Atrial Fibrillation Cohort Study on patients with atrial fibrillation in Switzerland

Outcome Measures

Primary Outcome Measures :

Stroke or systemic embolism [ Time Frame: 2018 (after an average of 2.5 years of follow-up) ]

Secondary Outcome Measures :

Hospitalization for heart failure [ Time Frame: 2018 (after an average of 2.5 years of follow-up) ]

Biospecimen Retention: Samples With DNA

samples with DNA

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	45 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Consecutive patients with atrial fibrillation

Criteria

Inclusion Criteria:

atrial fibrillation documented within the last 24 months
age >=45 years

Exclusion Criteria:

acute illness
inability to provide informed consent
Only short episodes of reversible forms of atrial fibrillation

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): NCT02105844

Locations

Layout table for location information

Switzerland
University Hospital
Basel, Basel-Stadt, Switzerland, 4031

Sponsors and Collaborators

University Hospital, Basel, Switzerland

Swiss National Science Foundation

Medical Image Analysis Center (MIAC) Basel

Schiller AG Baar

Clinical Trial Unit, University Hospital Basel, Switzerland

Cardiovascular Research Institute (CRIB) Basel

Cardiocentro Ticino

Investigators

Layout table for investigator information

Study Director:	Stefan Osswald, MD, Prof.	University Hospital, Basel, Switzerland
Principal Investigator:	Michael Kuehne, MD, PD, exec. MBA	University Hospital, Basel, Switzerland
Principal Investigator:	David Conen, MD MPH	McMaster University, Population Health Research Institute, Hamilton, Canada

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Girod M, Coslovsky M, Aeschbacher S, Sticherling C, Reichlin T, Roten L, Rodondi N, Ammann P, Auricchio A, Moschovitis G, Kobza R, Badertscher P, Knecht S, Krisai P, Marugg A, Aebersold H, Hennings E, Serra-Burriel M, Schwenkglenks M, Zuern CS, Bonati LH, Conen D, Osswald S, Kuhne M. Association of pulmonary vein isolation and major cardiovascular events in patients with atrial fibrillation. Clin Res Cardiol. 2022 Sep;111(9):1048-1056. doi: 10.1007/s00392-022-02015-0. Epub 2022 Apr 11.

Rivolta MW, Mainardi LT, Laureanti R, Sassi R, Kuhne M, Rodondi N, Conte G, Moschovitis G, Schlageter V, Aeschbacher S, Conen D, Reichlin T, Roten L, Osswald S, Zuern CS, Auricchio A, Corino VDA. Association between ventricular repolarization parameters and cardiovascular death in patients of the SWISS-AF cohort. Int J Cardiol. 2022 Jun 1;356:53-59. doi: 10.1016/j.ijcard.2022.03.009. Epub 2022 Mar 9.

Kuhne M, Krisai P, Coslovsky M, Rodondi N, Muller A, Beer JH, Ammann P, Auricchio A, Moschovitis G, Hayoz D, Kobza R, Shah D, Stephan FP, Schlapfer J, Di Valentino M, Aeschbacher S, Ehret G, Eken C, Monsch A, Roten L, Schwenkglenks M, Springer A, Sticherling C, Reichlin T, Zuern CS, Meyre PB, Blum S, Sinnecker T, Wurfel J, Bonati LH, Conen D, Osswald S; Swiss-AF Investigators. Silent brain infarcts impact on cognitive function in atrial fibrillation. Eur Heart J. 2022 Jun 6;43(22):2127-2135. doi: 10.1093/eurheartj/ehac020.

Bano A, Rodondi N, Beer JH, Moschovitis G, Kobza R, Aeschbacher S, Baretella O, Muka T, Stettler C, Franco OH, Conte G, Sticherling C, Zuern CS, Conen D, Kuhne M, Osswald S, Roten L, Reichlin T; of the Swiss-Investigators. Association of Diabetes With Atrial Fibrillation Phenotype and Cardiac and Neurological Comorbidities: Insights From the Swiss-AF Study. J Am Heart Assoc. 2021 Nov 16;10(22):e021800. doi: 10.1161/JAHA.121.021800. Epub 2021 Nov 10.

Hammerle P, Aeschbacher S, Springer A, Eken C, Coslovsky M, Dutilh G, Moschovitis G, Rodondi N, Chocano P, Conen D, Osswald S, Kuhne M, Zuern CS. Cardiac autonomic function and cognitive performance in patients with atrial fibrillation. Clin Res Cardiol. 2022 Jan;111(1):60-69. doi: 10.1007/s00392-021-01900-4. Epub 2021 Jun 22.

Hammerle P, Eick C, Poli S, Blum S, Schlageter V, Bauer A, Rizas KD, Eken C, Coslovsky M, Aeschbacher S, Krisai P, Meyre P, Wuerfel J, Sinnecker T, Vesin JM, Beer JH, Moschovitis G, Bonati LH, Sticherling C, Conen D, Osswald S, Kuhne M, Zuern CS. Association of Heart Rate Variability With Silent Brain Infarcts in Patients With Atrial Fibrillation. Front Cardiovasc Med. 2021 May 21;8:684461. doi: 10.3389/fcvm.2021.684461. eCollection 2021.

Benz AP, Aeschbacher S, Krisai P, Moschovitis G, Blum S, Meyre P, Blum MR, Rodondi N, Di Valentino M, Kobza R, De Perna ML, Bonati LH, Beer JH, Kuhne M, Osswald S, Conen D; BEAT-AF, Swiss-AF Investigators. Biomarkers of Inflammation and Risk of Hospitalization for Heart Failure in Patients With Atrial Fibrillation. J Am Heart Assoc. 2021 Apr 20;10(8):e019168. doi: 10.1161/JAHA.120.019168. Epub 2021 Apr 10.

Reddiess P, Aeschbacher S, Meyre P, Coslovsky M, Kuhne M, Rodondi N, Baretella O, Beer JH, Kobza R, Moschovitis G, Di Valentino M, Muller C, Steiner F, Bonati LH, Sticherling C, Osswald S, Conen D; BEAT-AF and Swiss-AF investigators. Alcohol consumption and risk of cardiovascular outcomes and bleeding in patients with established atrial fibrillation. CMAJ. 2021 Jan 25;193(4):E117-E123. doi: 10.1503/cmaj.200778.

Steiner F, Meyre PB, Aeschbacher S, Coslovsky M, Sinnecker T, Blum MR, Rodondi N, Cereda CW, di Valentino M, Wenger F, Cussigh A, Krisai P, Roten L, Reichlin T, Conen D, Osswald S, Bonati LH, Kuhne M; Swiss-AF Investigators. Association of the CHA2D(S2)-VASc Score and Its Components With Overt and Silent Ischemic Brain Lesions in Patients With Atrial Fibrillation. Front Neurol. 2021 Jan 12;11:609234. doi: 10.3389/fneur.2020.609234. eCollection 2020.

Aeschbacher S, Blum S, Meyre PB, Coslovsky M, Vischer AS, Sinnecker T, Rodondi N, Beer JH, Moschovitis G, Moutzouri E, Hunkeler C, Burkard T, Eken C, Roten L, Zuern CS, Sticherling C, Wuerfel J, Bonati LH, Conen D, Osswald S, Kuhne M; Swiss-AF Investigators*. Blood Pressure and Brain Lesions in Patients With Atrial Fibrillation. Hypertension. 2021 Feb;77(2):662-671. doi: 10.1161/HYPERTENSIONAHA.120.16025. Epub 2020 Dec 28.

Meyre PB, Springer A, Aeschbacher S, Blum S, Rodondi N, Beer JH, Di Valentino M, Ammann P, Blum M, Mathys R, Meyer-Zurn C, Bonati LH, Sticherling C, Schwenkglenks M, Kuhne M, Conen D, Osswald S; Swiss-AF investigators. Association of psychosocial factors with all-cause hospitalizations in patients with atrial fibrillation. Clin Cardiol. 2021 Jan;44(1):51-57. doi: 10.1002/clc.23503. Epub 2020 Nov 10.

Hammerle P, Eick C, Blum S, Schlageter V, Bauer A, Rizas KD, Eken C, Coslovsky M, Aeschbacher S, Krisai P, Meyre P, Vesin JM, Rodondi N, Moutzouri E, Beer J, Moschovitis G, Kobza R, Di Valentino M, Corino VDA, Laureanti R, Mainardi L, Bonati LH, Sticherling C, Conen D, Osswald S, Kuhne M, Zuern CS; Swiss-AF Study Investigators. Heart Rate Variability Triangular Index as a Predictor of Cardiovascular Mortality in Patients With Atrial Fibrillation. J Am Heart Assoc. 2020 Aug 4;9(15):e016075. doi: 10.1161/JAHA.120.016075. Epub 2020 Jul 28.

Gugganig R, Aeschbacher S, Leong DP, Meyre P, Blum S, Coslovsky M, Beer JH, Moschovitis G, Muller D, Anker D, Rodondi N, Stempfel S, Mueller C, Meyer-Zurn C, Kuhne M, Conen D, Osswald S; Swiss-AF Investigators. Frailty to predict unplanned hospitalization, stroke, bleeding, and death in atrial fibrillation. Eur Heart J Qual Care Clin Outcomes. 2021 Jan 25;7(1):42-51. doi: 10.1093/ehjqcco/qcaa002.

Layout table for additonal information

Responsible Party:	University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:	NCT02105844
Other Study ID Numbers:	SWISS-AF
First Posted:	April 7, 2014 Key Record Dates
Last Update Posted:	May 24, 2022
Last Verified:	May 2022

Keywords provided by University Hospital, Basel, Switzerland:


atrial fibrillation dementia cognitive dysfunction stroke Magnetic resonance imaging

Additional relevant MeSH terms:

Layout table for MeSH terms

Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes

To Top