Routine Versus Aggressive Upstream Rhythm Control for Prevention of Early Atrial Fibrillation in Heart Failure
This trial is active, not recruiting.
|Treatments||upstream therapy, conventional rhythm control|
|Sponsor||I.C. Van Gelder|
|Collaborator||The Interuniversity Cardiology Institute of the Netherlands|
|Start date||May 2009|
|End date||January 2017|
|Trial size||250 participants|
|Trial identifier||NCT00877643, NHS B 2008 035|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Almelo/Hengelo, Netherlands||Ziekenhuisgroep Twente||no longer recruiting|
|Amsterdam, Netherlands||Onze Lieve Vrouwe Gasthuis||no longer recruiting|
|Arnhem/Velp, Netherlands||Hospital Rijnstate||no longer recruiting|
|Blaricum, Netherlands||Ter Gooi Hospital||no longer recruiting|
|Breda, Netherlands||Amhia Hospital||no longer recruiting|
|Delfzijl, Netherlands||Ommelander Hospital Group||no longer recruiting|
|Deventer, Netherlands||Deventer Hospital||no longer recruiting|
|Goes, Netherlands||Oosterscheldeziekenhuis||no longer recruiting|
|Groningen, Netherlands||Martini Hospital||no longer recruiting|
|Groningen, Netherlands||University Medical Center Groningen||no longer recruiting|
|Haarlem, Netherlands||Kennemer Gasthuis||no longer recruiting|
|Maastricht, Netherlands||Medical University Center Maastricht||no longer recruiting|
|Nijmegen, Netherlands||University Medical Center Nijmegen||no longer recruiting|
|Venlo, Netherlands||Viecuri Hospital||no longer recruiting|
|Winschoten, Netherlands||Ommelander Hospital Group||no longer recruiting|
|Birmingham, United Kingdom||City Hospital (Sandwell and West Birmingham Hospitals NHS Trust)||no longer recruiting|
|Birmingham, United Kingdom||University Hospitals Birmingham NHS Foundation Trust||no longer recruiting|
|Leeds, United Kingdom||Leeds Teaching Hospitals NHS Trust||no longer recruiting|
|Poole, United Kingdom||Poole Hospital NHS Foundation Trust||no longer recruiting|
|Sutton Coldfield, United Kingdom||Good Hope Hospital (Heart of England NHS Foundation Trust)||no longer recruiting|
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
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
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
Male or female participants at least 40 years old.
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
|Official title||Routine Versus Aggressive Upstream Rhythm Control for Prevention of Early Atrial Fibrillation in Heart Failure: RACE 3|
|Principal investigator||Marco Alings, MD, PhD|
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