Title
Moxonidine for Prevention of Post-ablation AFib Recurrences
Pharmacologic Suppression of Central Sympathetic Activity for Prevention of Atrial Fibrillation Recurrence After Pulmonary Vein Isolation (MOXAF)
Phase
Phase 4Lead Sponsor
G.Gennimatas General HospitalStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Atrial FibrillationIntervention/Treatment
normocoxib ...Study Participants
150Hypothesis: Modulation of central nervous sympathetic activation by administration of moxonidine, a centrally acting medication which decreases the sympathetic nervous system activity, can lead to a decrease in atrial fibrillation recurrence after ablation treatment with pulmonary vein isolation.
The patients of the control group will undergo standard ablation procedure (pulmonary vein isolation) and will receive placebo, starting one week before scheduled ablation. Optimal antihypertensive treatment will be prescribed, with adequate follow-up to ensure good control of hypertension (goal <= 140/90).
Patients of the active treatment group will receive moxonidine in a starting dose of 0.2 mg daily. The first dose will be administered 1 week before scheduled ablation. 3 weeks after the first dose the daily dose will be increased to 0.4 mg, if the lower dose is well tolerated. Optimal antihypertensive treatment, in addition to moxonidine, will be prescribed, if needed, with adequate follow-up to ensure good control of hypertension (goal <= 140/90).
Inclusion Criteria: Hypertensive patients with paroxysmal atrial fibrillation. At least two documented episodes within the last 12 months (either self-terminating within 7 days or cardioverted, medically or electrically, in less than 48 hours). At least one episode should have been documented under treatment with a class Ic or III antiarrhythmic drug. Exclusion Criteria: age <25 or >80 years presence of atrial thrombus left atrial volume index >55 ml/m2 hypersensitivity to moxonidine sick sinus syndrome or sino-atrial block 2nd or 3rd degree atrioventricular block bradycardia (below 50 beats/minute at rest) estimated glomerular filtration rate <40 ml/min/1.73 m2 history of angioneurotic oedema heart failure symptoms OR impaired left ventricular function (EF <40%), even if asymptomatic stable or unstable angina pectoris intermittent claudication or known peripheral artery disease Parkinson's disease epileptic disorders glaucoma history of depression pregnancy or lactation inability or unwillingness to adhere to standard treatment or to provide consent.
