Persistent Atrial FibrillationPhase 4WISDOMNCT00845780
Withdrawal Versus Continuation of Amiodarone in Successfully Treated Patients With Persistent Atrial Fibrillation
A Phase 4 study testing withdrawal or continuation of amiodarone therapy in people with Persistent Atrial Fibrillation, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
Amiodarone is considered to be the most effective antiarrhythmic drug in the prevention of persistent atrial fibrillation. It can however cause many adverse events, both cardiac and non-cardiac. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Persistent Atrial Fibrillation
- What is being tested?
- withdrawal or continuation of amiodarone therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2000to Jun 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- history of persistent atrial fibrillation, necessitating at least one electrical cardioversion
- presence of sinus rhythm during the last 6 months, while on amiodarone treatment without adverse events related to amiodarone
- clinically stable
- age > 18 years
- written informed consent
Who cannot join
- sinus rhythm maintenance is preferable (because of atrial fibrillation related morbidity or any other reason)
- symptomatic heart failure NYHA III or IV
- unstable angina pectoris
- hemodynamically significant valvular disease
- concomitant treatment with other class I or III antiarrhythmic drug
- PCI,CABG, other cardiac surgery or major non-cardiac surgery within the last three months
- recent myocardial infarction (< 3 months)
- presence of any disease that is likely to shorten life expectancy to < 1 year
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
University Medical Center Groningen
Groningen, Provincie Groningen, 9700 RB
About this study
Official title: Withdrawal of Amiodarone Treatment Versus Continuation in Successfully Treated Patients With Persistent Atrial Fibrillation. A Randomized Study.
Amiodarone is considered to be the most effective antiarrhythmic drug in the prevention of persistent atrial fibrillation. It can however cause many adverse events, both cardiac and non-cardiac. Long-term maintenance of sinus rhythm after cardioversion is difficult especially because of high recurrence rates during the first month after cardioversion. Duration of atrial fibrillation, type of underlying disease, left ventricular function, left atrial size and age are associated with maintaining sinus rhythm. Early recurrence of atrial fibrillation may be related to a highly arrhythmogenic period due to recovery from electrical remodelling. Late recurrences may be related to other triggers than recovery from electrical remodelling. In this study the investigators want to investigate the effect of amiodarone withdrawal on the occurrence of late relapses of persistent atrial fibrillation. Furthermore, the investigators want to investigate the effect of amiodarone withdrawal on the occurrence of amiodarone related adverse events as well as adverse events related to atrial fibrillation or underlying heart disease. The investigators also want to investigate which patients characteristics are and potential triggers have a prognostic value in the occurence of late relapses after amiodarone withdrawal.
- Conditions
- Persistent Atrial Fibrillation
- Being tested
- withdrawal or continuation of amiodarone therapy
- Keywords
- persistent atrial fibrillation, amiodarone, late recurrence atrial fibrillation, adverse events
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
withdrawal or continuation of amiodarone therapyDrug
withdrawal or continuation of amiodarone therapy after at least 6 months sinus rhythm maintenance on amiodarone therapy
| Study group | Role | What they receive |
|---|---|---|
| withdrawal amiodarone | Experimental | withdrawal amiodarone afer at least 6 months of sinus rhythm maintenance on amiodarone therapy Receives: Drug: withdrawal or continuation of amiodarone therapy |
| continuation amiodarone | Active comparator | continuation of amiodarone after 6 months of sinus rhythm maintenance on amiodarone therapy Receives: Drug: withdrawal or continuation of amiodarone therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
occurrence of late relapse of persistent atrial fibrillation
Measured: 2 years
Secondary outcomes (1)
difference in occurrence of adverse events (amiodarone and atrial fibrillation/underlying heart disease related) between both strategies
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2009 (estimated)
- Study startAug 2000
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Investigators
- Isabelle C. Van Gelder, MD PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00845780
- Sponsor's protocol ID
- T377
- Acronym
- WISDOM
- Status last verified
- Jun 2009
- First submitted
- 17 Feb 2009
- Last updated
- 24 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Withdrawal of Amiodarone Treatment Versus Continuation in Successfully Treated Patients With Persistent Atrial Fibrillation. A Randomized Study.
- ClinicalTrials.gov ID
- NCT00845780
- Acronym / sponsor ID
- WISDOM / T377
- Conditions
- Persistent Atrial Fibrillation
- Keywords
- persistent atrial fibrillation, amiodarone, late recurrence atrial fibrillation, adverse events
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Aug 2000
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 18 Feb 2009 (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.
Amiodarone is considered to be the most effective antiarrhythmic drug in the prevention of persistent atrial fibrillation. It can however cause many adverse events, both cardiac and non-cardiac. Long-term maintenance of sinus rhythm after cardioversion is difficult especially because of high recurrence rates during the first month after cardioversion. Duration of atrial fibrillation, type of underlying disease, left ventricular function, left atrial size and age are associated with maintaining sinus rhythm. Early recurrence of atrial fibrillation may be related to a highly arrhythmogenic period due to recovery from electrical remodelling. Late recurrences may be related to other triggers than recovery from electrical remodelling. In this study the investigators want to investigate the effect of amiodarone withdrawal on the occurrence of late relapses of persistent atrial fibrillation. Furthermore, the investigators want to investigate the effect of amiodarone withdrawal on the occurrence of amiodarone related adverse events as well as adverse events related to atrial fibrillation or underlying heart disease. The investigators also want to investigate which patients characteristics are and potential triggers have a prognostic value in the occurence of late relapses after amiodarone withdrawal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| withdrawal amiodarone | Experimental | Drug: withdrawal or continuation of amiodarone therapywithdrawal amiodarone afer at least 6 months of sinus rhythm maintenance on amiodarone therapy |
| continuation amiodarone | Active comparator | Drug: withdrawal or continuation of amiodarone therapycontinuation of amiodarone after 6 months of sinus rhythm maintenance on amiodarone therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- history of persistent atrial fibrillation, necessitating at least one electrical cardioversion
- presence of sinus rhythm during the last 6 months, while on amiodarone treatment without adverse events related to amiodarone
- clinically stable
- age > 18 years
- written informed consent
Key exclusion criteria (8 listed)
- sinus rhythm maintenance is preferable (because of atrial fibrillation related morbidity or any other reason)
- symptomatic heart failure NYHA III or IV
- unstable angina pectoris
- hemodynamically significant valvular disease
- concomitant treatment with other class I or III antiarrhythmic drug
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 |
|---|---|---|
| withdrawal or continuation of amiodarone therapywithdrawal or continuation of amiodarone therapy after at least 6 months sinus rhythm maintenance on amiodarone therapy | Drug | continuation amiodarone, withdrawal amiodarone |
Primary outcome
occurrence of late relapse of persistent atrial fibrillation
Time frame: 2 years
1 secondary outcome
difference in occurrence of adverse events (amiodarone and atrial fibrillation/underlying heart disease related) between both strategies
Time frame: 2 years
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 24 Jun 2009.
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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.
Isabelle C. Van Gelder, MD PhD principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing withdrawal or continuation of amiodarone therapy in people with Persistent Atrial Fibrillation, run by University Medical Center Groningen at 1 site in Netherlands.
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 5 inclusion and 8 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 24 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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. 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?
occurrence of late relapse of persistent atrial fibrillation (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jun 2009.