Routine Versus Aggressive Upstream Rhythm Control for Prevention of Early Atrial Fibrillation in Heart Failure
NCT ID: NCT00877643
Last Updated: 2021-08-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
250 participants
INTERVENTIONAL
2009-05-04
2021-01-31
Brief Summary
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A randomized long term extension of the RACE 3 will be performed with a total follow-up of 5 years to investigate the long term effects on persistence of sinus rhythm and cardiovascular morbidity and mortality of the two treatment strategies.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Upstream rhythm control
Upstream therapy
Aldosterone receptor antagonists and statins, dietary restrictions, counseling, and cardiac rehabilitation.
Conventional rhythm control
Conventional rhythm control
Usual care for atrial fibrillation and heart failure according to the present guidelines
Interventions
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Upstream therapy
Aldosterone receptor antagonists and statins, dietary restrictions, counseling, and cardiac rehabilitation.
Conventional rhythm control
Usual care for atrial fibrillation and heart failure according to the present guidelines
Eligibility Criteria
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Inclusion Criteria
* Mild to moderate early heart failure
* Optimal documentation and treatment of underlying heart disease
* No contra-indication for oral anticoagulation
* Eligible for cardiovascular rehabilitation
* Age \>= 40 years
Exclusion Criteria
* Heart failure NYHA class IV
* LVEF \< 25%
* Left atrial size \> 50 mm (parasternal axis)
* Present aldosterone receptor antagonist use
* Previous use of class I or III antiarrhythmic drugs (except for sotalol, which should be discontinued at inclusion and replaced with betablocker)
* Cardiac resynchronization therapy
40 Years
ALL
No
Sponsors
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The Interuniversity Cardiology Institute of the Netherlands
OTHER_GOV
Netherlands Heart Foundation
OTHER
Dutch Network for Cardiovascular Research
UNKNOWN
Trial Coordination Center UMC Groningen
UNKNOWN
Bayer
INDUSTRY
Boehringer Ingelheim
INDUSTRY
Medtronic
INDUSTRY
Biotronik SE & Co. KG
INDUSTRY
Abbott Medical Devices
INDUSTRY
Boston Scientific Corporation
INDUSTRY
AstraZeneca
INDUSTRY
I.C. Van Gelder
OTHER
Responsible Party
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I.C. Van Gelder
Prof.
Principal Investigators
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Marco Alings, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Amphia Hospital Breda
Isabelle C Van Gelder, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Medical Center Groningen
Harry J Crijns, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Maastricht University Medical Center
Locations
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Ziekenhuisgroep Twente
Almelo, , Netherlands
Onze Lieve Vrouwe Gasthuis
Amsterdam, , Netherlands
Hospital Rijnstate
Arnhem, , Netherlands
Ter Gooi Hospital
Blaricum, , Netherlands
Amhia Hospital
Breda, , Netherlands
Ommelander Hospital Group
Delfzijl, , Netherlands
Deventer Hospital
Deventer, , Netherlands
Oosterscheldeziekenhuis
Goes, , Netherlands
Martini Hospital
Groningen, , Netherlands
University Medical Center Groningen
Groningen, , Netherlands
Kennemer Gasthuis
Haarlem, , Netherlands
Medical University Center Maastricht
Maastricht, , Netherlands
University Medical Center Nijmegen
Nijmegen, , Netherlands
Viecuri Hospital
Venlo, , Netherlands
Ommelander Hospital Group
Winschoten, , Netherlands
City Hospital (Sandwell and West Birmingham Hospitals NHS Trust)
Birmingham, , United Kingdom
University Hospitals Birmingham NHS Foundation Trust
Birmingham, , United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, , United Kingdom
Poole Hospital NHS Foundation Trust
Poole, , United Kingdom
Good Hope Hospital (Heart of England NHS Foundation Trust)
Sutton Coldfield, , United Kingdom
Countries
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References
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Nguyen BO, Crijns HJGM, Tijssen JGP, Geelhoed B, Hobbelt AH, Hemels MEW, Mol WJM, Weijs B, Alings M, Smit MD, Tieleman RG, Tukkie R, Van Veldhuisen DJ, Van Gelder IC, Rienstra M; RACE 3 Investigators. Long-term outcome of targeted therapy of underlying conditions in patients with early persistent atrial fibrillation and heart failure: data of the RACE 3 trial. Europace. 2022 Jul 15;24(6):910-920. doi: 10.1093/europace/euab270.
Nguyen BO, Rienstra M, Hobbelt AH, Tijssen JGP, Smit MD, Tieleman RG, Geelhoed B, Van Veldhuisen DJ, Crijns HJGM, Van Gelder IC; RACE 3 Investigators. Optimal treatment of underlying conditions improves rhythm control outcome in atrial fibrillation - Data from RACE 3. Am Heart J. 2020 Aug;226:235-239. doi: 10.1016/j.ahj.2019.12.005. Epub 2020 Feb 14. No abstract available.
De With RR, Rienstra M, Smit MD, Weijs B, Zwartkruis VW, Hobbelt AH, Alings M, Tijssen JGP, Brugemann J, Geelhoed B, Hillege HL, Tukkie R, Hemels ME, Tieleman RG, Ranchor AV, Van Veldhuisen DJ, Crijns HJGM, Van Gelder IC. Targeted therapy of underlying conditions improves quality of life in patients with persistent atrial fibrillation: results of the RACE 3 study. Europace. 2019 Apr 1;21(4):563-571. doi: 10.1093/europace/euy311.
Rienstra M, Hobbelt AH, Alings M, Tijssen JGP, Smit MD, Brugemann J, Geelhoed B, Tieleman RG, Hillege HL, Tukkie R, Van Veldhuisen DJ, Crijns HJGM, Van Gelder IC; RACE 3 Investigators. Targeted therapy of underlying conditions improves sinus rhythm maintenance in patients with persistent atrial fibrillation: results of the RACE 3 trial. Eur Heart J. 2018 Aug 21;39(32):2987-2996. doi: 10.1093/eurheartj/ehx739.
Other Identifiers
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NHS B 2008 035
Identifier Type: -
Identifier Source: secondary_id
NHS B 2008 035
Identifier Type: -
Identifier Source: org_study_id
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