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

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.

Conditions

• Atrial Fibrillation

Interventions

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

Sponsors & Collaborators

• The Interuniversity Cardiology Institute of the Netherlands

  collaborator OTHER_GOV

• Netherlands Heart Foundation

  collaborator OTHER

• Dutch Network for Cardiovascular Research

  collaborator UNKNOWN

• Trial Coordination Center UMC Groningen

  collaborator UNKNOWN

• Bayer

  collaborator INDUSTRY

• Boehringer Ingelheim

  collaborator INDUSTRY

• Medtronic

  collaborator INDUSTRY

• Biotronik SE & Co. KG

  collaborator INDUSTRY

• Abbott Medical Devices

  collaborator INDUSTRY

• Boston Scientific Corporation

  collaborator INDUSTRY

• AstraZeneca

  collaborator INDUSTRY

• I.C. Van Gelder

  lead OTHER

Principal Investigators

• Marco Alings, MD, PhD · Amphia Hospital Breda

• Isabelle C Van Gelder, MD, PhD · University Medical Center Groningen

• Harry J Crijns, MD, PhD · Maastricht University Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-05-04

Primary Completion

2018-02-01

Completion

2021-01-31

Countries

• Netherlands
• United Kingdom

Study Locations