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Moxonidine for Prevention of Post-ablation AFib Recurrences

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Phase 4
Locations
Greece
Study Type
Interventional
Intervention
Moxonidine
Placebo
Sponsored by
Spyridon Deftereos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring atrial fibrillation, paroxysmal, persistent, ablation, pulmonary vein isolation, recurrence

Eligibility Criteria

25 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Evangelismos General Hospital
  • Athens General Hospital "G. Gennimatas"
  • Red Cross Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Control group

Moxonidine group

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
February 13, 2013
Last Updated
May 4, 2014
Sponsor
Spyridon Deftereos
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1. Study Identification

Unique Protocol Identification Number
NCT01791699
Brief Title
Moxonidine for Prevention of Post-ablation AFib Recurrences
Official Title
Pharmacologic Suppression of Central Sympathetic Activity for Prevention of Atrial Fibrillation Recurrence After Pulmonary Vein Isolation (MOXAF)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Spyridon Deftereos

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
atrial fibrillation, paroxysmal, persistent, ablation, pulmonary vein isolation, recurrence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
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).
Arm Title
Moxonidine group
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Moxonidine
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
AFib recurrence
Description
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)
Time Frame
12 months+
Secondary Outcome Measure Information:
Title
Depressive symptoms
Description
The 17-item Hamilton Depression Rating Scale will be administered at baseline, and at the 3- and 6-month visits.
Time Frame
6 months
Title
Early AFib recurrence
Description
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
Time Frame
2 months
Other Pre-specified Outcome Measures:
Title
Adverse effects
Description
Moxonidine-related adverse effects will be monitored and recorded, focusing on xerostomia, headaches, sleep disorders, hypotension, orthostatic hypotension
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Evangelismos General Hospital
City
Athens
ZIP/Postal Code
10676
Country
Greece
Facility Name
Athens General Hospital "G. Gennimatas"
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
Red Cross Hospital
City
Athens
Country
Greece

12. IPD Sharing Statement

Citations:
PubMed Identifier
30520854
Citation
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.
Results Reference
derived
PubMed Identifier
25847478
Citation
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.
Results Reference
derived
PubMed Identifier
25147079
Citation
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.
Results Reference
derived

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Moxonidine for Prevention of Post-ablation AFib Recurrences

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