Routine versus Aggressive Upstream Rhythm Control for Prevention of Early Atrial Fibrillation in Heart Failure: RACE 3 - RACE 3

• Conditions: Atrial fibrillation and underlying diastolic or systolic heart failure.; MedDRA version: 14.1Level: PTClassification code 10003658Term: Atrial fibrillationSystem Organ Class: 10007541 - Cardiac disorders

• Registration Number: EUCTR2009-011291-29-NL
• Lead Sponsor: Interuniversity Cardiology Institute Netherlands

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-01
• Last Update Posted: 6 May 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Early persistent atrial fibrillation (total atrial fibrillation history < 5 years, total persistent atrial fibrillation duration > 7 days and < 6 months, and = 1 previous electrical cardioversions during the last 2 years; neither electrical nor chemical cardioversion = 2 years ago are allowed).
2. Mild to moderate early heart failure (Total heart failure history < 1 year, and normal pulmonary function and body mass index < 40 kg/m2, and either (1) left ventricular ejection fraction = 45% and New York Heart Association functional class II-III and signs of heart failure [previously documented heart failure-related NT-proBNP elevation, ór evidence of structural heart disease, ór previous admission for heart failure, ór diastolic dysfunction on echocardiography] ór (2) left ventricular ejection fraction 25-45% and New York Heart Association functional class I-III).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. On waiting list for pulmonary vein isolation (PVI) or expected to be placed on waiting list for PVI within one year.
2. Symptoms not allowing ECV to be delayed for 3 weeks.
3. Heart failure NYHA functional class IV.
4. Left ventricular ejection fraction < 25%.
5. Left atrial size > 50 mm (parasternal axis).
6. Severe valvular disease (previous valve repair/replacement is permitted).
7. Present ARA use.
8. Patients with cardiac resynchronization therapy.
9. Previous use of continuous prophylactic class I or class III antiarrhythmic drugs (except for sotalol, which should be discontinued at inclusion and replaced by a beta-blocker)
10. Postoperative AF.
11. Myocardial infarction within last 3 months.
12. Hypersensitivity against ARAs.
13. Unstable angina pectoris.
14. Open heart surgery within the last 3 months.
15. Serum potassium > 5 mmol/l.
16. Moderate to severe renal insufficiency (creatinine clearance less than 50 ml/min).
17. Patients with liver cirrhosis (Child-Pugh class C) or other significant liver disease.
18. Co-administration of strong CYP3A4 inhibitors or inductors.
19. Complex congenital heart disease.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified