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

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Upstream therapy
Conventional rhythm control
Sponsored by
I.C. Van Gelder
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ziekenhuisgroep Twente
  • Onze Lieve Vrouwe Gasthuis
  • Hospital Rijnstate
  • Ter Gooi Hospital
  • Amhia Hospital
  • Ommelander Hospital Group
  • Deventer Hospital
  • Oosterscheldeziekenhuis
  • Martini Hospital
  • University Medical Center Groningen
  • Kennemer Gasthuis
  • Medical University Center Maastricht
  • University Medical Center Nijmegen
  • Viecuri Hospital
  • Ommelander Hospital Group
  • City Hospital (Sandwell and West Birmingham Hospitals NHS Trust)
  • University Hospitals Birmingham NHS Foundation Trust
  • Leeds Teaching Hospitals NHS Trust
  • Poole Hospital NHS Foundation Trust
  • Good Hope Hospital (Heart of England NHS Foundation Trust)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Upstream rhythm control

Conventional rhythm control

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Exploratory randomized long term extension of the RACE 3 study performed to study the long term effects of the two treatment strategies.

Full Information

First Posted
April 7, 2009
Last Updated
August 17, 2021
Sponsor
I.C. Van Gelder
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, Abbott Medical Devices, Boston Scientific Corporation, AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00877643
Brief Title
Routine Versus Aggressive Upstream Rhythm Control for Prevention of Early Atrial Fibrillation in Heart Failure
Acronym
RACE 3
Official Title
Routine Versus Aggressive Upstream Rhythm Control for Prevention of Early Atrial Fibrillation in Heart Failure: RACE 3
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
May 4, 2009 (Actual)
Primary Completion Date
February 1, 2018 (Actual)
Study Completion Date
January 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
I.C. Van Gelder
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, Abbott Medical Devices, Boston Scientific Corporation, AstraZeneca

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Upstream rhythm control
Arm Type
Experimental
Arm Title
Conventional rhythm control
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Upstream therapy
Intervention Description
Aldosterone receptor antagonists and statins, dietary restrictions, counseling, and cardiac rehabilitation.
Intervention Type
Other
Intervention Name(s)
Conventional rhythm control
Intervention Description
Usual care for atrial fibrillation and heart failure according to the present guidelines
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Alings, MD, PhD
Organizational Affiliation
Amphia Hospital Breda
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Isabelle C Van Gelder, MD, PhD
Organizational Affiliation
University Medical Center Groningen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Harry J Crijns, MD, PhD
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ziekenhuisgroep Twente
City
Almelo
Country
Netherlands
Facility Name
Onze Lieve Vrouwe Gasthuis
City
Amsterdam
Country
Netherlands
Facility Name
Hospital Rijnstate
City
Arnhem
Country
Netherlands
Facility Name
Ter Gooi Hospital
City
Blaricum
Country
Netherlands
Facility Name
Amhia Hospital
City
Breda
Country
Netherlands
Facility Name
Ommelander Hospital Group
City
Delfzijl
Country
Netherlands
Facility Name
Deventer Hospital
City
Deventer
Country
Netherlands
Facility Name
Oosterscheldeziekenhuis
City
Goes
Country
Netherlands
Facility Name
Martini Hospital
City
Groningen
Country
Netherlands
Facility Name
University Medical Center Groningen
City
Groningen
Country
Netherlands
Facility Name
Kennemer Gasthuis
City
Haarlem
Country
Netherlands
Facility Name
Medical University Center Maastricht
City
Maastricht
Country
Netherlands
Facility Name
University Medical Center Nijmegen
City
Nijmegen
Country
Netherlands
Facility Name
Viecuri Hospital
City
Venlo
Country
Netherlands
Facility Name
Ommelander Hospital Group
City
Winschoten
Country
Netherlands
Facility Name
City Hospital (Sandwell and West Birmingham Hospitals NHS Trust)
City
Birmingham
Country
United Kingdom
Facility Name
University Hospitals Birmingham NHS Foundation Trust
City
Birmingham
Country
United Kingdom
Facility Name
Leeds Teaching Hospitals NHS Trust
City
Leeds
Country
United Kingdom
Facility Name
Poole Hospital NHS Foundation Trust
City
Poole
Country
United Kingdom
Facility Name
Good Hope Hospital (Heart of England NHS Foundation Trust)
City
Sutton Coldfield
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
34791160
Citation
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.
Results Reference
derived
PubMed Identifier
32067695
Citation
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.
Results Reference
derived
PubMed Identifier
30629160
Citation
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.
Results Reference
derived
PubMed Identifier
29401239
Citation
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.
Results Reference
derived

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Routine Versus Aggressive Upstream Rhythm Control for Prevention of Early Atrial Fibrillation in Heart Failure

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