Moxonidine for Prevention of Post-ablation AFib Recurrences

Spyridon Deftereos

Status and phase: Completed; Phase 4

Conditions: Atrial Fibrillation

Treatments: Drug: Placebo; Drug: Moxonidine

Study type: Interventional

Funder types: Other

Identifiers

NCT01791699

MOX.AFABL.9.5.2012

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 25 to 80 years old

Volunteers: No Healthy Volunteers

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

1. age <25 or >80 years
2. presence of atrial thrombus
3. left atrial volume index >55 ml/m2
4. hypersensitivity to moxonidine
5. sick sinus syndrome or sino-atrial block
6. 2nd or 3rd degree atrioventricular block
7. bradycardia (below 50 beats/minute at rest)
8. estimated glomerular filtration rate <40 ml/min/1.73 m2
9. history of angioneurotic oedema
10. heart failure symptoms OR impaired left ventricular function (EF <40%), even if asymptomatic
11. stable or unstable angina pectoris
12. intermittent claudication or known peripheral artery disease
13. Parkinson's disease
14. epileptic disorders
15. glaucoma
16. history of depression
17. pregnancy or lactation
18. inability or unwillingness to adhere to standard treatment or to provide consent.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups, including a placebo group

Control group

Placebo Comparator group

Description:

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).

Treatment:

Drug: Placebo

Moxonidine group

Active Comparator group

Description:

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).

Treatment:

Drug: Moxonidine