Clinical trial NCT00877643: Routine Versus Aggressive Upstream Rhythm Control for Prevention of Early Atrial Fibrillation in Heart Failure
Official title: Routine Versus Aggressive Upstream Rhythm Control for Prevention of Early Atrial Fibrillation in Heart Failure: RACE 3
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: The Interuniversity Cardiology Institute of the Netherlands
name: Netherlands Heart Foundation
name: Dutch Network for Cardiovascular Research
name: Trial Coordination Center UMC Groningen
name: Bayer
name: Boehringer Ingelheim
name: Medtronic
name: Biotronik SE & Co. KG
name: Abbott Medical Devices
name: Boston Scientific Corporation
name: AstraZeneca
First posted: 2009-04-08
Enrollment: 250
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: 1 year after electrical cardioversion
Secondary outcomes:
measure: Exploratory randomized long term extension of the RACE 3 study performed to study the long term effects of the two treatment strategies.
timeFrame: 5 years after electrical cardioversion
Other outcomes:
Locations:
city: Almelo
country: Netherlands
facility: Ziekenhuisgroep Twente
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis
city: Arnhem
country: Netherlands
facility: Hospital Rijnstate
city: Blaricum
country: Netherlands
facility: Ter Gooi Hospital
city: Breda
country: Netherlands
facility: Amhia Hospital
city: Delfzijl
country: Netherlands
facility: Ommelander Hospital Group
city: Deventer
country: Netherlands
facility: Deventer Hospital
city: Goes
country: Netherlands
facility: Oosterscheldeziekenhuis
city: Groningen
country: Netherlands
facility: Martini Hospital
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Haarlem
country: Netherlands
facility: Kennemer Gasthuis
city: Maastricht
country: Netherlands
facility: Medical University Center Maastricht
city: Nijmegen
country: Netherlands
facility: University Medical Center Nijmegen
city: Venlo
country: Netherlands
facility: Viecuri Hospital
city: Winschoten
country: Netherlands
facility: Ommelander Hospital Group
city: Birmingham
country: United Kingdom
facility: City Hospital (Sandwell and West Birmingham Hospitals NHS Trust)
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust
city: Poole
country: United Kingdom
facility: Poole Hospital NHS Foundation Trust
city: Sutton Coldfield
country: United Kingdom
facility: Good Hope Hospital (Heart of England NHS Foundation Trust)
Study officials:
affiliation: Amphia Hospital Breda
name: Marco Alings, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Medical Center Groningen
name: Isabelle C Van Gelder, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastricht University Medical Center
name: Harry J Crijns, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nguyen BO, Crijns HJGM, Tijssen JGP, Geelhoed B, Hobbelt AH, Hemels MEW, Mol WJM, Weijs B, Alings M, Smit MD, Tieleman RG, Tukkie R, Van Veldhuisen DJ, Van Gelder IC, Rienstra M; RACE 3 Investigators. Long-term outcome of targeted therapy of underlying conditions in patients with early persistent atrial fibrillation and heart failure: data of the RACE 3 trial. Europace. 2022 Jul 15;24(6):910-920. doi: 10.1093/europace/euab270.
citation: Nguyen BO, Rienstra M, Hobbelt AH, Tijssen JGP, Smit MD, Tieleman RG, Geelhoed B, Van Veldhuisen DJ, Crijns HJGM, Van Gelder IC; RACE 3 Investigators. Optimal treatment of underlying conditions improves rhythm control outcome in atrial fibrillation - Data from RACE 3. Am Heart J. 2020 Aug;226:235-239. doi: 10.1016/j.ahj.2019.12.005. Epub 2020 Feb 14. No abstract available.
citation: De With RR, Rienstra M, Smit MD, Weijs B, Zwartkruis VW, Hobbelt AH, Alings M, Tijssen JGP, Brugemann J, Geelhoed B, Hillege HL, Tukkie R, Hemels ME, Tieleman RG, Ranchor AV, Van Veldhuisen DJ, Crijns HJGM, Van Gelder IC. Targeted therapy of underlying conditions improves quality of life in patients with persistent atrial fibrillation: results of the RACE 3 study. Europace. 2019 Apr 1;21(4):563-571. doi: 10.1093/europace/euy311.
citation: Rienstra M, Hobbelt AH, Alings M, Tijssen JGP, Smit MD, Brugemann J, Geelhoed B, Tieleman RG, Hillege HL, Tukkie R, Van Veldhuisen DJ, Crijns HJGM, Van Gelder IC; RACE 3 Investigators. Targeted therapy of underlying conditions improves sinus rhythm maintenance in patients with persistent atrial fibrillation: results of the RACE 3 trial. Eur Heart J. 2018 Aug 21;39(32):2987-2996. doi: 10.1093/eurheartj/ehx739.