Moxonidine for Prevention of Post-ablation AFib Recurrences

NCT01791699 | Completed Phase 4 DMC

• 1 other identifier: MOX.AFABL.9.5.2012
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation; paroxysmal; persistent; ablation; pulmonary vein isolation; recurrence

Outcome Measures

Primary Outcomes (1)

• AFib recurrence

  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 Outcomes (2)

• Depressive symptoms

  6 months

• Early AFib recurrence

  2 months

Other Outcomes (1)

• Adverse effects

  6 months

Study Arms (2)

Control group

PLACEBO COMPARATOR

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

Moxonidine group

ACTIVE COMPARATOR

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

Interventions

Moxonidine DRUG

Moxonidine group

Placebo DRUG

Control group

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• nd 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

Sponsors & Collaborators

• Spyridon Deftereos: lead

Study Sites (3)

Evangelismos General Hospital

Athens, 10676, Greece

Location

Athens General Hospital "G. Gennimatas"

Athens, 11527, Greece

Location

Red Cross Hospital

Athens, Greece

Location

Related Publications (3)

• Giannopoulos G, Vrachatis D, Kossyvakis C, Angelidis C, Koutivas A, Tsitsinakis G, Zacharoulis A, Kolokathis F, Palaiologos D, Vavuranakis M, Deftereos S. Effect of Postablation Statin Treatment on Arrhythmia Recurrence in Patients With Paroxysmal Atrial Fibrillation. J Cardiovasc Pharmacol. 2018 Dec;72(6):285-290. doi: 10.1097/FJC.0000000000000624.

  PMID: 30520854 DERIVED

• Giannopoulos G, Kossyvakis C, Angelidis C, Efremidis M, Panagopoulou V, Letsas K, Bouras G, Vassilikos VP, Goudevenos J, Tousoulis D, Lekakis J, Deftereos S. Amino-terminal B-natriuretic peptide levels and postablation recurrence in hypertensive patients with paroxysmal atrial fibrillation. Heart Rhythm. 2015 Jul;12(7):1470-5. doi: 10.1016/j.hrthm.2015.04.002. Epub 2015 Apr 3.

  PMID: 25847478 DERIVED

• Giannopoulos G, Kossyvakis C, Efremidis M, Katsivas A, Panagopoulou V, Doudoumis K, Raisakis K, Letsas K, Rentoukas I, Pyrgakis V, Manolis AS, Tousoulis D, Stefanadis C, Deftereos S. Central sympathetic inhibition to reduce postablation atrial fibrillation recurrences in hypertensive patients: a randomized, controlled study. Circulation. 2014 Oct 14;130(16):1346-52. doi: 10.1161/CIRCULATIONAHA.114.010999. Epub 2014 Aug 21.

  PMID: 25147079 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Recurrence

Interventions

moxonidine

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director; Catheterization Laboratory and Cardiac Electrophysiology Laboratory

Study Record Dates

• First Submitted: February 13, 2013
• First Posted: February 15, 2013
• Study Start: August 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: April 1, 2014
• Last Updated: May 6, 2014

Record last verified: 2014-05

Locations

GR (3)