atrial fibrillation
Conditions
Interventions
Dronedarone or intensified standard treatment.
Sponsors
Sanofi-aventis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Paroxysmal AF (according to ACC/AHA/ESC 2006 definition) with HR >80 bpm at rest despite treatment with 45 years of age. • Anticoagulant treatment in line with local guidelines.
Exclusion criteria
Exclusion criteria: • Incapacitated patients. • Permanent AF (according to ACC/AHA/ESC 2006 definition). • Use of class I or III AADs in the past 3 months. • Patients scheduled for cardioversion or pulmonary vein ablation. • Unstable NYHA class III and all class IV HF. • AV block grade 2 or 3. • Known severe renal impairment (serum creatinine >180 µmol/l). • Known severe hepatic impairment (AST, ALT >3x ULN). • Contra-indication for dronedarone. • Participation in a clinical drug study in the 3 months prior to inclusion. • Women of childbearing potential, who do not use adequate contraception (in the opinion of the investigator). • Lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ventricular rate after 1 week. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Ventricular rate after 3 months. - Number of registered AF episodes. - Number of symptomatic AF episodes. - Severity of AF and AF-like symptoms. - Adverse events. - Rate of premature study discontinuation (*going off study prematurely*). - Number of symptomatic episodes of bradycardia. - Incidence of low heart rate ( | — |
Countries
Netherlands
Outcome results
None listed