Completed
Pharmacologic Suppression of Central Sympathetic Activity for Prevention of Atrial Fibrillation Recurrence After Pulmonary Vein Isolation (MOXAF)
What is being tested
Placebo
+ Moxonidine
Drug
Who is being recruted
Arrhythmias, Cardiac+5
+ Cardiovascular Diseases
+ Heart Diseases
From 25 to 80 Years
+21 Eligibility Criteria
How is the trial designed
Treatment Study
Placebo-ControlledPhase 4
Interventional
Study Start: August 2012
Summary
Principal SponsorSpyridon Deftereos
Last updated: May 6, 2014
Sourced from a government-validated database.Claim as a partner
Study start date: August 1, 2012
Actual date on which the first participant was enrolled.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.
Principal SponsorSpyridon Deftereos
Last updated: May 6, 2014
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
150 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 25 to 80 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Arrhythmias, CardiacCardiovascular DiseasesHeart DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDisease AttributesAtrial FibrillationRecurrence
Criteria
3 inclusion criteria required to participate
At least one episode should have been documented under treatment with a class Ic or III antiarrhythmic drug
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)
Hypertensive patients with paroxysmal atrial fibrillation
18 exclusion criteria prevent from participating
2nd or 3rd degree atrioventricular block
Parkinson's disease
age < 25 or > 80 years
bradycardia (below 50 beats/minute at rest)
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
PlaceboThe 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).
Group II
Active ComparatorPatients 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).
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 3 locations
Athens General Hospital "G. Gennimatas"
Athens, GreeceRed Cross Hospital
Athens, GreeceCompleted3 Study Centers