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

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Other: Conventional rhythm control; Other: Upstream therapy

• Registration Number: NCT00877643
• Lead Sponsor: I.C. Van Gelder

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-04-07
• Study First Submitted QC: 2009-04-07
• Study First Posted: 2009-04-08
• Study Start: 2009-05-04
• Primary Completion: 2018-02-01
• Study Completion: 2021-01-31
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-17
• Last Update Posted: 2021-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional rhythm control	Conventional rhythm control	-
Upstream rhythm control	Upstream therapy	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (19)

Hospital Rijnstate; 🇳🇱 Arnhem, Netherlands

Ter Gooi Hospital; 🇳🇱 Blaricum, Netherlands

Martini Hospital; 🇳🇱 Groningen, Netherlands

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands

Ommelander Hospital Group; 🇳🇱 Winschoten, Netherlands

Deventer Hospital; 🇳🇱 Deventer, Netherlands

University Medical Center Nijmegen; 🇳🇱 Nijmegen, Netherlands

Ziekenhuisgroep Twente; 🇳🇱 Almelo, Netherlands

Onze Lieve Vrouwe Gasthuis; 🇳🇱 Amsterdam, Netherlands

Amhia Hospital; 🇳🇱 Breda, Netherlands

Oosterscheldeziekenhuis; 🇳🇱 Goes, Netherlands

Kennemer Gasthuis; 🇳🇱 Haarlem, Netherlands

Medical University Center Maastricht; 🇳🇱 Maastricht, Netherlands

Viecuri Hospital; 🇳🇱 Venlo, Netherlands

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, United Kingdom