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 April 2009 by University Medical Centre Groningen

First Received on April 7, 2009. Last Updated on June 24, 2011 History of Changes

Sponsor:	University Medical Centre Groningen
Collaborators:	Netherlands Heart Foundation Interuniversity Cardiology Institute Netherlands Working group Cardiology Netherlands Trial Coordination Center UMC Groningen Sanofi-Aventis Boehringer Ingelheim Pharmaceuticals Medtronic Biotronik SE & 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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Routine Versus Aggressive Upstream Rhythm Control for Prevention of Early Atrial Fibrillation in Heart Failure: RACE 3

Resource links provided by NLM:

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

MedlinePlus related topics: Atrial Fibrillation Heart Failure

U.S. FDA Resources

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:	May 2009
Estimated Study Completion Date:	January 2013
Estimated Primary Completion Date:	January 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	40 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 >= 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

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
Ziekenhuisgroep Twente	Recruiting
Almelo, Netherlands
Onze Lieve Vrouwe Gasthuis	Recruiting
Amsterdam, Netherlands
Hospital Rijnstate	Recruiting
Arnhem/Velp, Netherlands
Ter Gooi Hospital	Recruiting
Blaricum, Netherlands
Amhia Hospital	Recruiting
Breda, Netherlands
Deventer Hospital	Recruiting
Deventer, Netherlands
Oosterscheldeziekenhuis	Recruiting
Goes, Netherlands
University Medical Center Groningen	Recruiting
Groningen, Netherlands
Martini Hospital	Recruiting
Groningen, Netherlands
Kennemer Gasthuis	Recruiting
Haarlem, Netherlands
Medical University Center Maastricht	Recruiting
Maastricht, Netherlands
University Medical Center Nijmegen	Recruiting
Nijmegen, Netherlands
Ommelander Hospital	Recruiting
Winschoten, Netherlands
United Kingdom
City Hospital (Sandwell and West Birmingham Hospitals NHS Trust)	Not yet recruiting
Birmingham, United Kingdom
University Hospitals Birmingham NHS Foundation Trust	Not yet recruiting
Birmingham, United Kingdom
Leeds Teaching Hospitals NHS Trust	Not yet recruiting
Leeds, United Kingdom
Poole Hospital NHS Foundation Trust	Not yet recruiting
Poole, United Kingdom
Good Hope Hospital (Heart of England NHS Foundation Trust)	Not yet recruiting
Sutton Coldfield, United Kingdom
Walsall Manor Hospital (Walsall Healthcare NHS Trust)	Not yet recruiting
Walsall, United Kingdom

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 SE & 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:	Isabelle C. Van Gelder, University Medical Center Groningen
ClinicalTrials.gov Identifier:	NCT00877643 History of Changes
Other Study ID Numbers:	NHS B 2008 035, NHS B 2008 035
Study First Received:	April 7, 2009
Last Updated:	June 24, 2011
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Netherlands: Medical Ethics Review Committee (METC) United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:

Atrial Fibrillation
Heart Failure
Arrhythmias, Cardiac

Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 24, 2012