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

Interuniversity Cardiology Institute Netherlands0 个研究点开始时间: 2013年5月1日最近更新: 2013年5月6日

试验速览

暂无简介。

•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

•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.

发起方

Interuniversity Cardiology Institute Netherlands