Moxonidine for Prevention of Post-ablation AFib Recurrences

Study Overview
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Brief Summary
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Hypothesis: 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.

Official Title
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Pharmacologic Suppression of Central Sympathetic Activity for Prevention of Atrial Fibrillation Recurrence After Pulmonary Vein Isolation (MOXAF)

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Drug: Moxonidine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control group<br>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). | Drug: Placebo<br> <br> |
| Active Comparator: Moxonidine group<br>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). | Drug: Moxonidine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AFib recurrence | Any of the following, occuring after a 3-month blanking period, will be considered an AF recurrence: symptomatic recurrence (AF/MRAT of any duration in ECGs performed in patients reporting symptoms of arrhythmia); the patients will be encouraged to visit the research site or any affiliated center to have an ECG performed at any time (24/7) they may feel symptoms of arrhythmia during the study follow-up AF/MRAT of at least 30 seconds in duration in 48-hour Holter recordings performed monthly AF/MRAT of any duration recorded in electrocardiograms performed during patient visits at the arrhythmia clinic, even if the patient is asymptomatic (AF=atrial fibrillation, MRAT=macro-reentrant atrial tachycardia) | 12 months+ | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depressive symptoms | The 17-item Hamilton Depression Rating Scale will be administered at baseline, and at the 3- and 6-month visits. | 6 months | 
| Early AFib recurrence | Any of the following, occuring within 2 months post-ablation, will be considered an early AF recurrence: symptomatic recurrence (AF/MRAT of any duration in ECGs performed in patients reporting symptoms of arrhythmia); the patients will be encouraged to visit the research site or any affiliated center to have an ECG performed at any time (24/7) they may feel symptoms of arrhythmia during the study follow-up AF/MRAT of at least 30 seconds in duration in 48-hour Holter recordings performed monthly AF/MRAT of any duration recorded in electrocardiograms performed during patient visits at the arrhythmia clinic, even if the patient is asymptomatic | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atrial fibrillation, paroxysmal, persistent, ablation, pulmonary vein isolation, recurrence