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
  Purpose

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.


Condition Intervention Phase
Atrial Fibrillation
Drug: Moxonidine
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pharmacologic Suppression of Central Sympathetic Activity for Prevention of Atrial Fibrillation Recurrence After Pulmonary Vein Isolation (MOXAF)

Resource links provided by NLM:


Further study details as provided by G.Gennimatas General Hospital:

Primary Outcome Measures:
  • 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)



Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • 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


Estimated Enrollment: 150
Study Start Date: August 2012
Study Completion Date: April 2014
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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).

Drug: Moxonidine

  Eligibility

Ages Eligible for Study:   25 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01791699

Locations
Greece
Athens General Hospital "G. Gennimatas"
Athens, Greece, 11527
Evangelismos General Hospital
Athens, Greece, 10676
Red Cross Hospital
Athens, Greece
Sponsors and Collaborators
Spyridon Deftereos
  More Information

No publications provided

Responsible Party: Spyridon Deftereos, Director; Catheterization Laboratory and Cardiac Electrophysiology Laboratory, G.Gennimatas General Hospital
ClinicalTrials.gov Identifier: NCT01791699     History of Changes
Other Study ID Numbers: MOX.AFABL.9.5.2012
Study First Received: February 13, 2013
Last Updated: May 4, 2014
Health Authority: Greece: Ethics Committee

Keywords provided by G.Gennimatas General Hospital:
atrial fibrillation
paroxysmal
persistent
ablation
pulmonary vein isolation
recurrence

Additional relevant MeSH terms:
Atrial Fibrillation
Recurrence
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Disease Attributes
Moxonidine
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014