Atrial Fibrillation Clinical Trial
Official title:
Pharmacologic Suppression of Central Sympathetic Activity for Prevention of Atrial Fibrillation Recurrence After Pulmonary Vein Isolation (MOXAF)
Verified date | May 2014 |
Source | G.Gennimatas General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Greece: Ethics Committee |
Study type | Interventional |
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.
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Greece | Athens General Hospital "G. Gennimatas" | Athens | |
Greece | Evangelismos General Hospital | Athens | |
Greece | Red Cross Hospital | Athens |
Lead Sponsor | Collaborator |
---|---|
Spyridon Deftereos |
Greece,
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 |
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