Atrial FibrillationPhase 4NCT01791699
Moxonidine for Prevention of Post-ablation AFib Recurrences
A Phase 4 study testing Moxonidine in people with Atrial Fibrillation, run by Spyridon Deftereos at 3 sites in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Moxonidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 3 sitesGreece
- Study dates
- Aug 2012to Apr 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 18Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
Greece3 sites
Evangelismos General Hospital
Athens, 10676
Athens General Hospital "G. Gennimatas"
Athens, 11527
Red Cross Hospital
Athens
About this study
Official title: 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.
- Conditions
- Atrial Fibrillation
- Being tested
- Moxonidine, Placebo
- Keywords
- atrial fibrillation, paroxysmal, persistent, ablation, pulmonary vein isolation, recurrence
- Medical subject headings
- Atrial Fibrillation, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MoxonidineDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Drug: Moxonidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 months+
Secondary outcomes (2)
Depressive symptoms
The 17-item Hamilton Depression Rating Scale will be administered at baseline, and at the 3- and 6-month visits.
Measured: 6 months
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
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study startAug 2012
- Primary completionNov 2013
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spyridon Deftereos
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Spyridon Deftereos, G.Gennimatas General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01791699
- Sponsor's protocol ID
- MOX.AFABL.9.5.2012
- Status last verified
- May 2014
- First submitted
- 13 Feb 2013
- Last updated
- 6 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 30520854Giannopoulos 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.
PubMed 25847478Giannopoulos 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.
PubMed 25147079
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacologic Suppression of Central Sympathetic Activity for Prevention of Atrial Fibrillation Recurrence After Pulmonary Vein Isolation (MOXAF)
- ClinicalTrials.gov ID
- NCT01791699
- Acronym / sponsor ID
- MOX.AFABL.9.5.2012
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, paroxysmal, persistent, ablation, pulmonary vein isolation, recurrence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Spyridon DeftereosUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 15 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Drug: 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). |
| Moxonidine group | Active comparator | Drug: MoxonidinePatients 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). |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moxonidine | Drug | Moxonidine group |
| Placebo | Drug | Control group |
Primary outcome
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)
2 secondary outcomes
Depressive symptoms
Time frame: 6 months
Early AFib recurrence
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2014.
- Derived from this study: PubMed 30520854Giannopoulos 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.
- Derived from this study: PubMed 25847478Giannopoulos 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.
- Derived from this study: PubMed 25147079Giannopoulos 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.
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Moxonidine in people with Atrial Fibrillation, run by Spyridon Deftereos at 3 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AFib recurrence (time frame: 12 months+). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01791699, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2014.