Moxonidine for Prevention of Post-ablation AFib Recurrences

May 4, 2014 updated by: Spyridon Deftereos

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece
        • Red Cross Hospital
      • Athens, Greece, 10676
        • Evangelismos General Hospital
      • Athens, Greece, 11527
        • Athens General Hospital "G. Gennimatas"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
12 months+

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months
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
2 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse effects
Time Frame: 6 months
Moxonidine-related adverse effects will be monitored and recorded, focusing on xerostomia, headaches, sleep disorders, hypotension, orthostatic hypotension
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spyridon Deftereos

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (ACTUAL)

November 1, 2013

Study Completion (ACTUAL)

April 1, 2014

Study Registration Dates

First Submitted

February 13, 2013

First Submitted That Met QC Criteria

February 13, 2013

First Posted (ESTIMATE)

February 15, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

May 6, 2014

Last Update Submitted That Met QC Criteria

May 4, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MOX.AFABL.9.5.2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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