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OpenTrials
Completed

NCT Number: NCT00877643

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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ziekenhuisgroep Twente, Almelo, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Upstream therapy

Other

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

Conventional rhythm control

Other

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

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.

    Time frame: 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.

    Time frame: 5 years after electrical cardioversion

Sponsors and collaborators

Lead sponsor

I.C. Van Gelder

Other

Collaborators

  • Abbott Medical Devices
  • AstraZeneca
  • Bayer
  • Biotronik SE & Co. KG
  • Boehringer Ingelheim
  • Boston Scientific Corporation
  • Dutch Network for Cardiovascular Research
  • Medtronic
  • Netherlands Heart Foundation
  • The Interuniversity Cardiology Institute of the Netherlands
  • Trial Coordination Center UMC Groningen

Registry information

Official study title

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

Acronym: RACE 3

Important dates

Study start
2009
Primary completion
2018
Study completion
2021
First posted
Apr 8, 2009
Registry last updated
Aug 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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