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OpenTrials
Completed

NCT Number: NCT01791699

Moxonidine for Prevention of Post-ablation AFib Recurrences

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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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Disease Attributes Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

25 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Athens General Hospital "G. Gennimatas", Athens, Greece

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • age <25 or >80 years
  • presence of atrial thrombus
  • left atrial volume index >55 ml/m2
  • hypersensitivity to moxonidine
  • sick sinus syndrome or sino-atrial block
  • 2nd or 3rd degree atrioventricular block
  • bradycardia (below 50 beats/minute at rest)
  • estimated glomerular filtration rate <40 ml/min/1.73 m2
  • history of angioneurotic oedema
  • heart failure symptoms OR impaired left ventricular function (EF <40%), even if asymptomatic
  • stable or unstable angina pectoris
  • intermittent claudication or known peripheral artery disease
  • Parkinson's disease
  • epileptic disorders
  • glaucoma
  • history of depression
  • pregnancy or lactation
  • inability or unwillingness to adhere to standard treatment or to provide consent.

Treatment and study plan

Moxonidine

Drug

Placebo

Drug

Primary outcomes

  1. AFib recurrence

    Time frame: 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 outcomes

  1. Depressive symptoms

    Time frame: 6 months

    The 17-item Hamilton Depression Rating Scale will be administered at baseline, and at the 3- and 6-month visits.

  2. Early AFib recurrence

    Time frame: 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 outcomes

  1. Adverse effects

    Time frame: 6 months

    Moxonidine-related adverse effects will be monitored and recorded, focusing on xerostomia, headaches, sleep disorders, hypotension, orthostatic hypotension

Sponsors and collaborators

Lead sponsor

Spyridon Deftereos

Other

Registry information

Official study title

Pharmacologic Suppression of Central Sympathetic Activity for Prevention of Atrial Fibrillation Recurrence After Pulmonary Vein Isolation (MOXAF)

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Feb 15, 2013
Registry last updated
May 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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