Moxonidine for Prevention of Post-ablation AFib Recurrences

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01791699
• Other study ID #: MOX.AFABL.9.5.2012
• Status: Completed
• Phase: Phase 4
• First received: February 13, 2013
• Last updated: May 4, 2014
• Start date: August 2012
• Est. completion date: April 2014

Study information

• Verified date: May 2014
• Source: G.Gennimatas General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: April 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Recurrence

Intervention

Drug:
• Moxonidine

• Placebo

Locations

Country	Name	City	State
Greece	Athens General Hospital "G. Gennimatas"	Athens
Greece	Evangelismos General Hospital	Athens
Greece	Red Cross Hospital	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Spyridon Deftereos

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse effects	Moxonidine-related adverse effects will be monitored and recorded, focusing on xerostomia, headaches, sleep disorders, hypotension, orthostatic hypotension	6 months	Yes
Primary	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+	No
Secondary	Depressive symptoms	The 17-item Hamilton Depression Rating Scale will be administered at baseline, and at the 3- and 6-month visits.	6 months	Yes
Secondary	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	No