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Moxonidine for Prevention of Post-ablation AFib Recurrences

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Spyridon Deftereos, G.Gennimatas General Hospital
ClinicalTrials.gov Identifier:
NCT01791699
First received: February 13, 2013
Last updated: May 4, 2014
Last verified: May 2014

February 13, 2013
May 4, 2014
August 2012
November 2013   (final data collection date for primary outcome measure)
AFib recurrence [ Time Frame: 12 months+ ] [ Designated as safety issue: No ]

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)

AFib recurrence [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Any of the following, occuring after a 2-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)

Complete list of historical versions of study NCT01791699 on ClinicalTrials.gov Archive Site
  • Depressive symptoms [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    The 17-item Hamilton Depression Rating Scale will be administered at baseline, and at the 3- and 6-month visits.
  • Early AFib recurrence [ Time Frame: 2 months ] [ Designated as safety issue: No ]

    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
Same as current
Adverse effects [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Moxonidine-related adverse effects will be monitored and recorded, focusing on xerostomia, headaches, sleep disorders, hypotension, orthostatic hypotension
Same as current
 
Moxonidine for Prevention of Post-ablation AFib Recurrences
Pharmacologic Suppression of Central Sympathetic Activity for Prevention of Atrial Fibrillation Recurrence After Pulmonary Vein Isolation (MOXAF)

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Atrial Fibrillation
  • Drug: Moxonidine
  • Drug: Placebo
  • Placebo Comparator: Control group

    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).

    Intervention: Drug: Placebo
  • Active Comparator: Moxonidine group

    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).

    Intervention: Drug: Moxonidine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
April 2014
November 2013   (final data collection date for primary outcome measure)

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.
Both
25 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Greece
 
NCT01791699
MOX.AFABL.9.5.2012
Yes
Spyridon Deftereos, G.Gennimatas General Hospital
Spyridon Deftereos
Not Provided
Not Provided
G.Gennimatas General Hospital
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP