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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by University Medical Centre Groningen
Sponsor:
Collaborators:
The Interuniversity Cardiology Institute of the Netherlands
Netherlands Heart Foundation
Working group Cardiology Netherlands
Trial Coordination Center UMC Groningen
Bayer
Boehringer Ingelheim
Medtronic
Biotronik SE & Co. KG
St. Jude Medical
Boston Scientific Corporation
AstraZeneca
Information provided by (Responsible Party):
I.C. Van Gelder, University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT00877643
First received: April 7, 2009
Last updated: March 7, 2013
Last verified: March 2013
  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 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.


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:


Further study details as provided by University Medical Centre Groningen:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: May 2009
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: July 2015 (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
Usual care for atrial fibrillation and heart failure according to the present guidelines

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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@umcg.nl

Locations
Netherlands
Ziekenhuisgroep Twente Recruiting
Almelo/Hengelo, 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
Ommelander Hospital Group Not yet recruiting
Delfzijl, Netherlands
Deventer Hospital Recruiting
Deventer, Netherlands
Oosterscheldeziekenhuis Recruiting
Goes, Netherlands
Martini Hospital Recruiting
Groningen, Netherlands
University Medical Center Groningen Recruiting
Groningen, Netherlands
Kennemer Gasthuis Recruiting
Haarlem, Netherlands
Medical University Center Maastricht Recruiting
Maastricht, Netherlands
University Medical Center Nijmegen Recruiting
Nijmegen, Netherlands
Viecuri Hospital Not yet recruiting
Venlo, Netherlands
Ommelander Hospital Group Recruiting
Winschoten, Netherlands
United Kingdom
City Hospital (Sandwell and West Birmingham Hospitals NHS Trust) Recruiting
Birmingham, United Kingdom
University Hospitals Birmingham NHS Foundation Trust Not yet recruiting
Birmingham, United Kingdom
Leeds Teaching Hospitals NHS Trust Recruiting
Leeds, United Kingdom
Poole Hospital NHS Foundation Trust Recruiting
Poole, United Kingdom
Good Hope Hospital (Heart of England NHS Foundation Trust) Not yet recruiting
Sutton Coldfield, United Kingdom
Sponsors and Collaborators
I.C. Van Gelder
The Interuniversity Cardiology Institute of the Netherlands
Netherlands Heart Foundation
Working group Cardiology Netherlands
Trial Coordination Center UMC Groningen
Bayer
Boehringer Ingelheim
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: I.C. Van Gelder, Prof., University Medical Centre 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: March 7, 2013
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
Aldosterone Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014