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

August 17, 2021 updated by: I.C. Van Gelder

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Almelo, Netherlands
        • Ziekenhuisgroep Twente
      • Amsterdam, Netherlands
        • Onze Lieve Vrouwe Gasthuis
      • Arnhem, Netherlands
        • Hospital Rijnstate
      • Blaricum, Netherlands
        • Ter Gooi Hospital
      • Breda, Netherlands
        • Amhia Hospital
      • Delfzijl, Netherlands
        • Ommelander Hospital Group
      • Deventer, Netherlands
        • Deventer Hospital
      • Goes, Netherlands
        • Oosterscheldeziekenhuis
      • Groningen, Netherlands
        • University Medical Center Groningen
      • Groningen, Netherlands
        • Martini Hospital
      • Haarlem, Netherlands
        • Kennemer Gasthuis
      • Maastricht, Netherlands
        • Medical University Center Maastricht
      • Nijmegen, Netherlands
        • University Medical Center Nijmegen
      • Venlo, Netherlands
        • VieCuri Hospital
      • Winschoten, Netherlands
        • Ommelander Hospital Group
  • United Kingdom
      • Birmingham, United Kingdom
        • University Hospitals Birmingham NHS Foundation Trust
      • Birmingham, United Kingdom
        • City Hospital (Sandwell and West Birmingham Hospitals NHS Trust)
      • Leeds, United Kingdom
        • Leeds Teaching Hospitals NHS Trust
      • Poole, United Kingdom
        • Poole Hospital NHS Foundation Trust
      • Sutton Coldfield, United Kingdom
        • Good Hope Hospital (Heart of England NHS Foundation Trust)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Upstream rhythm control
Other: Upstream therapy
Aldosterone receptor antagonists and statins, dietary restrictions, counseling, and cardiac rehabilitation.
ACTIVE_COMPARATOR: Conventional rhythm control
Other: Conventional rhythm control
Usual care for atrial fibrillation and heart failure according to the present guidelines

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1 year after electrical cardioversion

Secondary Outcome Measures

Outcome Measure
Time Frame
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
5 years after electrical cardioversion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

I.C. Van Gelder

Collaborators

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

Investigators

  • Principal Investigator: Marco Alings, MD, PhD, Amphia hospital Breda
  • Principal Investigator: Harry J Crijns, MD, PhD, Maastricht University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 4, 2009

Primary Completion (ACTUAL)

February 1, 2018

Study Completion (ACTUAL)

January 31, 2021

Study Registration Dates

First Submitted

April 7, 2009

First Submitted That Met QC Criteria

April 7, 2009

First Posted (ESTIMATE)

April 8, 2009

Study Record Updates

Last Update Posted (ACTUAL)

August 19, 2021

Last Update Submitted That Met QC Criteria

August 17, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NHS B 2008 035

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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