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Routine Versus Aggressive Upstream Rhythm Control for Prevention of Early Atrial Fibrillation in Heart Failure (RACE 3)

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ClinicalTrials.gov Identifier: NCT00877643
Recruitment Status : Active, not recruiting
First Posted : April 8, 2009
Last Update Posted : October 29, 2018
Sponsor:
Collaborators:
The Interuniversity Cardiology Institute of the Netherlands
Netherlands Heart Foundation
Dutch Network for Cardiovascular Research
Trial Coordination Center UMC Groningen
Bayer
Boehringer Ingelheim
Medtronic
Biotronik SE & Co. KG
St. Jude Medical
Boston Scientific Corporation
AstraZeneca
Information provided by (Responsible Party):
I.C. Van Gelder, University Medical Center Groningen

April 7, 2009
April 8, 2009
October 29, 2018
May 2009
May 1, 2017   (Final data collection date for primary outcome measure)
Success of rhythm control strategy consisting of 1) the patient is still in a rhythm control strategy according to the attending physician, and 2) that sinus rhythm is maintained after 1 year of follow-up. [ Time Frame: 1 year after electrical cardioversion ]
Sinus rhythm [ Time Frame: 1 year after electrical cardioversion ]
Complete list of historical versions of study NCT00877643 on ClinicalTrials.gov Archive Site
Exploratory randomized long term extension of the RACE 3 study performed to study the long term effects of the two treatment strategies. [ Time Frame: 5 years after electrical cardioversion ]
Not Provided
Not Provided
Not Provided
 
Routine Versus Aggressive Upstream Rhythm Control for Prevention of Early Atrial Fibrillation in Heart Failure
Routine Versus Aggressive Upstream Rhythm Control for Prevention of Early Atrial Fibrillation in Heart Failure: RACE 3

The purpose of this study is to investigate whether in patients with early persistent atrial fibrillation and mild to moderate early heart failure an aggressive upstream rhythm control approach, including aldosterone receptor antagonists and statins, dietary restrictions, counseling and cardiac rehabilitation programs, increases persistence of sinus rhythm compared with conventional rhythm control after one year of follow-up.

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.

Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Atrial Fibrillation
  • Other: Upstream therapy
    Aldosterone receptor antagonists and statins, dietary restrictions, counseling, and cardiac rehabilitation.
  • Other: Conventional rhythm control
    Usual care for atrial fibrillation and heart failure according to the present guidelines
  • Experimental: Upstream rhythm control
    Intervention: Other: Upstream therapy
  • Active Comparator: Conventional rhythm control
    Intervention: Other: Conventional rhythm control
Rienstra M, Hobbelt AH, Alings M, Tijssen JGP, Smit MD, Brügemann 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
250
Same as current
January 2021
May 1, 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Early symptomatic persistent atrial fibrillation
  • 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:

  • On waiting list for pulmonary vein isolation or expected to be placed on waiting list within one year
  • 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
Sexes Eligible for Study: All
40 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Netherlands,   United Kingdom
 
 
NCT00877643
NHS B 2008 035
NHS B 2008 035
Yes
Not Provided
Not Provided
I.C. Van Gelder, University Medical Center Groningen
I.C. Van Gelder
  • The Interuniversity Cardiology Institute of the Netherlands
  • Netherlands Heart Foundation
  • Dutch Network for Cardiovascular Research
  • Trial Coordination Center UMC Groningen
  • Bayer
  • Boehringer Ingelheim
  • Medtronic
  • Biotronik SE & Co. KG
  • St. Jude Medical
  • Boston Scientific Corporation
  • AstraZeneca
Principal Investigator: Marco Alings, MD, PhD Amphia Hospital, Breda
Principal Investigator: Isabelle C Van Gelder, MD, PhD University Medical Center Groningen
Principal Investigator: Harry J Crijns, MD, PhD Maastricht University Medical Center
University Medical Center Groningen
October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP