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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Placebo Comparator | 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 | Active Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moxonidine | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| AFib recurrence | Any of the following, occuring after a 3-month blanking period, will be considered an AF recurrence:
(AF=atrial fibrillation, MRAT=macro-reentrant atrial tachycardia) | 12 months+ |
| Measure | Description | Time Frame |
|---|---|---|
| Depressive symptoms | The 17-item Hamilton Depression Rating Scale will be administered at baseline, and at the 3- and 6-month visits. | 6 months |
| Early AFib recurrence | Any of the following, occuring within 2 months post-ablation, will be considered an early AF recurrence:
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse effects | Moxonidine-related adverse effects will be monitored and recorded, focusing on xerostomia, headaches, sleep disorders, hypotension, orthostatic hypotension | 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Evangelismos General Hospital | Athens | 10676 | Greece | |||
| Athens General Hospital "G. Gennimatas" |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30520854 | Derived | Giannopoulos G, Vrachatis D, Kossyvakis C, Angelidis C, Koutivas A, Tsitsinakis G, Zacharoulis A, Kolokathis F, Palaiologos D, Vavuranakis M, Deftereos S. Effect of Postablation Statin Treatment on Arrhythmia Recurrence in Patients With Paroxysmal Atrial Fibrillation. J Cardiovasc Pharmacol. 2018 Dec;72(6):285-290. doi: 10.1097/FJC.0000000000000624. | |
| 25847478 |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| C043482 | moxonidine |
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|
| 2 months |
| Athens |
| 11527 |
| Greece |
| Red Cross Hospital | Athens | Greece |
| Giannopoulos G, Kossyvakis C, Angelidis C, Efremidis M, Panagopoulou V, Letsas K, Bouras G, Vassilikos VP, Goudevenos J, Tousoulis D, Lekakis J, Deftereos S. Amino-terminal B-natriuretic peptide levels and postablation recurrence in hypertensive patients with paroxysmal atrial fibrillation. Heart Rhythm. 2015 Jul;12(7):1470-5. doi: 10.1016/j.hrthm.2015.04.002. Epub 2015 Apr 3. |
| 25147079 | Derived | Giannopoulos G, Kossyvakis C, Efremidis M, Katsivas A, Panagopoulou V, Doudoumis K, Raisakis K, Letsas K, Rentoukas I, Pyrgakis V, Manolis AS, Tousoulis D, Stefanadis C, Deftereos S. Central sympathetic inhibition to reduce postablation atrial fibrillation recurrences in hypertensive patients: a randomized, controlled study. Circulation. 2014 Oct 14;130(16):1346-52. doi: 10.1161/CIRCULATIONAHA.114.010999. Epub 2014 Aug 21. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |