Moxonidine for Prevention of Post-ablation AFib Recurrences

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2014-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Ablation STrategies for Repeat PrOcedures in Patients With Atrial Fibrillation Recurrences

NCT04056390

Atrial Fibrillation

ACTIVE_NOT_RECRUITING NA

Repeat Ablation Procedure in Patients With Relapse of Atrial Fibrillation

NCT01229306

Ablation Paroxysmal Atrial Fibrillation

UNKNOWN NA

Effect of Cryoballoon and RF Ablation on Left Atrial Function

NCT02611869

Atrial Fibrillation

UNKNOWN NA

Durability of Pulmonary Vein Isolation Following Cryoablation for Treatment of Paroxysmal Atrial Fibrillation

NCT01645917

Paroxysmal Atrial Fibrillation

COMPLETED PHASE4

Ajmaline Utilization in the Diagnosis and Treatment of Cardiac Arrhythmias

NCT00702117

Atrial Fibrillation Tachycardia, Ventricular Brugada Syndrome

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atrial Fibrillation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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).

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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).

Group Type ACTIVE_COMPARATOR

Moxonidine

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Moxonidine

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

25 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No