Routine Versus Aggressive Upstream Rhythm Control for Prevention of Early Atrial Fibrillation in Heart Failure (RACE 3)
This study is currently recruiting participants.
Verified March 2013 by University Medical Centre Groningen
Sponsor:
I.C. Van Gelder
Collaborators:
The Interuniversity Cardiology Institute of the Netherlands
Netherlands Heart Foundation
Working group Cardiology Netherlands
Trial Coordination Center UMC Groningen
Bayer
Boehringer Ingelheim Pharmaceuticals
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
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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
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 Pharmaceuticals
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 May 16, 2013