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

Atrial Fibrillation Clinical Trial

— RACE 3  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00877643
• Other study ID #: NHS B 2008 035
• Secondary ID: NHS B 2008 035
• Status: Completed
• Phase: N/A
• Start date: May 4, 2009
• Est. completion date: January 31, 2021

Study information

• Verified date: August 2021
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: January 31, 2021
• Est. primary completion date: February 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Heart Failure

Intervention

Other:
• Upstream therapy
Aldosterone receptor antagonists and statins, dietary restrictions, counseling, and cardiac rehabilitation.
• Conventional rhythm control
Usual care for atrial fibrillation and heart failure according to the present guidelines

Locations

Country	Name	City	State
Netherlands	Ziekenhuisgroep Twente	Almelo
Netherlands	Onze Lieve Vrouwe Gasthuis	Amsterdam
Netherlands	Hospital Rijnstate	Arnhem
Netherlands	Ter Gooi Hospital	Blaricum
Netherlands	Amhia Hospital	Breda
Netherlands	Ommelander Hospital Group	Delfzijl
Netherlands	Deventer Hospital	Deventer
Netherlands	Oosterscheldeziekenhuis	Goes
Netherlands	Martini Hospital	Groningen
Netherlands	University Medical Center Groningen	Groningen
Netherlands	Kennemer Gasthuis	Haarlem
Netherlands	Medical University Center Maastricht	Maastricht
Netherlands	University Medical Center Nijmegen	Nijmegen
Netherlands	Viecuri Hospital	Venlo
Netherlands	Ommelander Hospital Group	Winschoten
United Kingdom	City Hospital (Sandwell and West Birmingham Hospitals NHS Trust)	Birmingham
United Kingdom	University Hospitals Birmingham NHS Foundation Trust	Birmingham
United Kingdom	Leeds Teaching Hospitals NHS Trust	Leeds
United Kingdom	Poole Hospital NHS Foundation Trust	Poole
United Kingdom	Good Hope Hospital (Heart of England NHS Foundation Trust)	Sutton Coldfield

Sponsors (12)

Lead Sponsor	Collaborator
I.C. Van Gelder	Abbott Medical Devices, AstraZeneca, Bayer, Biotronik SE & Co. KG, Boehringer Ingelheim, Boston Scientific Corporation, Dutch Network for Cardiovascular Research, Medtronic, Netherlands Heart Foundation, The Interuniversity Cardiology Institute of the Netherlands, Trial Coordination Center UMC Groningen

Countries where clinical trial is conducted

Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		1 year after electrical cardioversion
Secondary	Exploratory randomized long term extension of the RACE 3 study performed to study the long term effects of the two treatment strategies.		5 years after electrical cardioversion