Moxonidine for Prevention of Post-ablation AFib Recurrences

Phase 4

Completed

• Conditions: Atrial Fibrillation
• Interventions: Drug: Placebo; Drug: Moxonidine

• Registration Number: NCT01791699
• Lead Sponsor: Spyridon Deftereos

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2013-02-13
• Study First Submitted QC: 2013-02-13
• Study First Posted: 2013-02-15
• Primary Completion: 2013-11
• Study Completion: 2014-04
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-04
• Last Update Posted: 2014-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Placebo	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).
Moxonidine group	Moxonidine	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).

Primary Outcome Measures

Name	Time	Method
AFib recurrence	12 months+	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)

Secondary Outcome Measures

Name	Time	Method
Depressive symptoms	6 months	The 17-item Hamilton Depression Rating Scale will be administered at baseline, and at the 3- and 6-month visits.
Early AFib recurrence	2 months	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

Trial Locations

Locations (3)

Red Cross Hospital; 🇬🇷 Athens, Greece

Evangelismos General Hospital; 🇬🇷 Athens, Greece

Athens General Hospital "G. Gennimatas"; 🇬🇷 Athens, Greece