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| ID | Type | Description | Link |
|---|---|---|---|
| NHS B 2008 035 |
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| Name | Class |
|---|---|
| The Interuniversity Cardiology Institute of the Netherlands | OTHER_GOV |
| Netherlands Heart Foundation | OTHER |
| Dutch Network for Cardiovascular Research | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Upstream rhythm control | Experimental |
| |
| Conventional rhythm control | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Upstream therapy | Other | Aldosterone receptor antagonists and statins, dietary restrictions, counseling, and cardiac rehabilitation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziekenhuisgroep Twente | Almelo | Netherlands | ||||
| Onze Lieve Vrouwe Gasthuis |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34791160 | Derived | 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. | |
| 32067695 |
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| Trial Coordination Center UMC Groningen |
| UNKNOWN |
| Bayer | INDUSTRY |
| Boehringer Ingelheim | INDUSTRY |
| Medtronic | INDUSTRY |
| Biotronik SE & Co. KG | INDUSTRY |
| Abbott Medical Devices | INDUSTRY |
| Boston Scientific Corporation | INDUSTRY |
| AstraZeneca | INDUSTRY |
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| Conventional rhythm control | Other | Usual care for atrial fibrillation and heart failure according to the present guidelines |
|
| 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 | 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 |
| Derived |
| 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. |
| 30629160 | Derived | 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. |
| 29401239 | Derived | 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. |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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