Atrial Fibrillation
Conditions
Keywords
atrial fibrillation, paroxysmal, persistent, ablation, pulmonary vein isolation, recurrence
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.
Interventions
DRUGMoxonidine
DRUGPlacebo
Sponsors
Spyridon Deftereos
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse effects | 6 months | Moxonidine-related adverse effects will be monitored and recorded, focusing on xerostomia, headaches, sleep disorders, hypotension, orthostatic hypotension |
Countries
Greece
Outcome results
None listed