Routine Versus Aggressive Upstream Rhythm Control for Prevention of Early Atrial Fibrillation in Heart Failure - Full Text View

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

This study is currently recruiting participants.

Verified by University Medical Centre Groningen, April 2009

First Received: April 7, 2009 No Changes Posted

Sponsors and Collaborators:	University Medical Centre Groningen Netherlands Heart Foundation Interuniversity Cardiology Institute Netherlands Working group Cardiology Netherlands Trial Coordination Center UMC Groningen Sanofi-Aventis Boehringer Ingelheim Pharmaceuticals Medtronic Biotronik GmbH & Co. KG St. Jude Medical Boston Scientific Corporation AstraZeneca
Information provided by:	University Medical Centre Groningen
ClinicalTrials.gov Identifier:	NCT00877643

Purpose

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.

Condition	Intervention
Atrial Fibrillation	Other: Upstream therapy Other: Conventional rhythm control

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation Heart Failure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Routine Versus Aggressive Upstream Rhythm Control for Prevention of Early Atrial Fibrillation in Heart Failure: RACE 3

Further study details as provided by University Medical Centre Groningen:

Primary Outcome Measures:

Sinus rhythm [ Time Frame: 1 year after electrical cardioversion ] [ Designated as safety issue: No ]

Estimated Enrollment:	250
Study Start Date:	April 2009
Estimated Study Completion Date:	January 2012
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Upstream rhythm control: Experimental	Other: Upstream therapy Aldosterone receptor antagonists and statins, dietary restrictions, counseling, and cardiac rehabilitation.
Conventional rhythm control: Active Comparator	Other: Conventional rhythm control

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 > 18 years

Exclusion Criteria:

Not 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
Cardiac resynchronization therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00877643

Contacts

Contact: Isabelle C Van Gelder, MD, PhD

+31-50-361-1327

i.c.van.gelder@thorax.umcg.nl

Locations

Netherlands
Amhia Hospital	Not yet recruiting
Breda, Netherlands
Medical University Center Maastricht	Not yet recruiting
Maastricht, Netherlands
Medical Spectrum Twente	Not yet recruiting
Enschede, Netherlands
Kennemer Gasthuis	Not yet recruiting
Haarlem, Netherlands
Ziekenhuisgroep Twente	Not yet recruiting
Almelo, Netherlands
Hospital Rijnstate	Not yet recruiting
Arnhem/Velp, Netherlands
Ter Gooi Hospital	Not yet recruiting
Blaricum, Netherlands
IJsselland Hospital	Not yet recruiting
Capelle a/d IJssel, Netherlands
MCH Westeinde	Not yet recruiting
The Hague, Netherlands
University Medical Center Nijmegen	Not yet recruiting
Nijmegen, Netherlands
Oosterscheldeziekenhuis	Not yet recruiting
Goes, Netherlands
Martini Hospital	Not yet recruiting
Groningen, Netherlands
Hospital St. Jansdal	Not yet recruiting
Harderwijk, Netherlands
De Tjongerschans	Not yet recruiting
Heerenveen, Netherlands
St. Elisabeth Hospital	Not yet recruiting
Tilburg, Netherlands
University Medical Center Groningen	Recruiting
Groningen, Netherlands
Rijnland Hospital	Not yet recruiting
Leiderdorp, Netherlands
Hospital Gelderse Vallei	Not yet recruiting
Ede, Netherlands

Sponsors and Collaborators

University Medical Centre Groningen

Netherlands Heart Foundation

Interuniversity Cardiology Institute Netherlands

Working group Cardiology Netherlands

Trial Coordination Center UMC Groningen

Sanofi-Aventis

Boehringer Ingelheim Pharmaceuticals

Medtronic

Biotronik GmbH & Co. KG

St. Jude Medical

Boston Scientific Corporation

AstraZeneca

Investigators

Principal Investigator:	Marco Alings, MD, PhD	Amphia Hospital, Breda
Principal Investigator:	Isabelle C Van Gelder, MD, PhD	University Medical Centre Groningen
Principal Investigator:	Harry J Crijns, MD, PhD	Maastricht University Medical Center

More Information

No publications provided

Responsible Party:	University Medical Center Groningen ( Isabelle C. Van Gelder )
Study ID Numbers:	NHS B 2008 035, NHS B 2008 035
Study First Received:	April 7, 2009
Last Updated:	April 7, 2009
ClinicalTrials.gov Identifier:	NCT00877643 History of Changes
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study placed in the following topic categories:

Heart Failure
Heart Diseases
Atrial Fibrillation

Hydroxymethylglutaryl-CoA Reductase Inhibitors
Aggression
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Heart Failure
Pathologic Processes
Heart Diseases

Cardiovascular Diseases
Atrial Fibrillation
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on May 07, 2009