Routine Versus Aggressive Upstream Rhythm Control for Prevention of Early Atrial Fibrillation in Heart Failure (RACE 3)
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|ClinicalTrials.gov Identifier: NCT00877643|
Recruitment Status : Active, not recruiting
First Posted : April 8, 2009
Last Update Posted : October 29, 2018
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 or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Other: Upstream therapy Other: Conventional rhythm control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Routine Versus Aggressive Upstream Rhythm Control for Prevention of Early Atrial Fibrillation in Heart Failure: RACE 3|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||May 1, 2017|
|Estimated Study Completion Date :||January 2021|
|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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00877643
|Principal Investigator:||Marco Alings, MD, PhD||Amphia Hospital Breda|
|Principal Investigator:||Isabelle C Van Gelder, MD, PhD||University Medical Center Groningen|
|Principal Investigator:||Harry J Crijns, MD, PhD||Maastricht University Medical Center|