NCT00877643

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P50-P75 for not_applicable atrial-fibrillation

Timeline
Completed

Started May 2009

Longer than P75 for not_applicable atrial-fibrillation

Geographic Reach
2 countries

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 8, 2009

Completed
26 days until next milestone

Study Start

First participant enrolled

May 4, 2009

Completed
8.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2021

Completed
Last Updated

August 19, 2021

Status Verified

August 1, 2021

Enrollment Period

8.8 years

First QC Date

April 7, 2009

Last Update Submit

August 17, 2021

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 year after electrical cardioversion

Secondary Outcomes (1)

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

    5 years after electrical cardioversion

Study Arms (2)

Upstream rhythm control

EXPERIMENTAL
Other: Upstream therapy

Conventional rhythm control

ACTIVE COMPARATOR
Other: Conventional rhythm control

Interventions

Upstream therapyOTHER

Aldosterone receptor antagonists and statins, dietary restrictions, counseling, and cardiac rehabilitation.

Upstream rhythm control
Conventional rhythm controlOTHER

Usual care for atrial fibrillation and heart failure according to the present guidelines

Conventional rhythm control

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Cardiac resynchronization therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Ziekenhuisgroep Twente

Almelo, Netherlands

Location

Onze Lieve Vrouwe Gasthuis

Amsterdam, Netherlands

Location

Hospital Rijnstate

Arnhem, Netherlands

Location

Ter Gooi Hospital

Blaricum, Netherlands

Location

Amhia Hospital

Breda, Netherlands

Location

Ommelander Hospital Group

Delfzijl, Netherlands

Location

Deventer Hospital

Deventer, Netherlands

Location

Oosterscheldeziekenhuis

Goes, Netherlands

Location

Martini Hospital

Groningen, Netherlands

Location

University Medical Center Groningen

Groningen, Netherlands

Location

Kennemer Gasthuis

Haarlem, Netherlands

Location

Medical University Center Maastricht

Maastricht, Netherlands

Location

University Medical Center Nijmegen

Nijmegen, Netherlands

Location

Viecuri Hospital

Venlo, Netherlands

Location

Ommelander Hospital Group

Winschoten, Netherlands

Location

City Hospital (Sandwell and West Birmingham Hospitals NHS Trust)

Birmingham, United Kingdom

Location

University Hospitals Birmingham NHS Foundation Trust

Birmingham, United Kingdom

Location

Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom

Location

Poole Hospital NHS Foundation Trust

Poole, United Kingdom

Location

Good Hope Hospital (Heart of England NHS Foundation Trust)

Sutton Coldfield, United Kingdom

Location

Related Publications (4)

  • 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.

    PMID: 34791160DERIVED

  • 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.

    PMID: 32067695DERIVED

  • 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.

    PMID: 30629160DERIVED

  • 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.

    PMID: 29401239DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

April 7, 2009

First Posted

April 8, 2009

Study Start

May 4, 2009

Primary Completion

February 1, 2018

Study Completion

January 31, 2021

Last Updated

August 19, 2021

Record last verified: 2021-08

Locations

NL(15)GB(5)