Persistant Atrial FibrillationNCT00392431
Continuous Versus Episodic Amiodarone Treatment for the Prevention of Permanent Atrial Fibrillation
A study testing amiodarone in people with Persistant Atrial Fibrillation, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
Our hypothesis is that episodic amiodarone treatment (i.e. amiodarone treatment 1 month prior until 1 month after cardioversion) is associated with a lower morbidity and a higher quality of life compared to continuous prophylactic amiodarone treatment while atrial fibrillation is still effectively suppressed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Persistant Atrial Fibrillation
- What is being tested?
- amiodarone
- How many people
- 220 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2003to Mar 2007
- Phase
- Interventional
- 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
- Symptomatic persistent atrial fibrillation for at least 48 hours- 1 year (present episode).
- Older than 18 years of age.
- Ventricular rate during AF > 75 beats per minute, documented on rest-ECG without rate control.
- At least two weeks of oral anticoagulation therapy before screening.
- Written informed consent.
Who cannot join
- Contra indications for amiodarone (severe chronic obstructive pulmonary disease or QTc > 440ms).
- History of relapse of AF during adequate amiodarone treatment (i.e. adequate amiodarone and desethylamiodarone plasma levels).
- Concomitant treatment with class I or III antiarrhythmic drugs. Amiodarone should not have been used during the last 3 months.
- Other (non) cardiac QT prolonging drugs (if not possible to discontinue).
- First episode of persistent atrial fibrillation.
- More than three relapses of persistent atrial fibrillation necessitating electrical cardioversion during the last three years.
Show all 21Show fewer
- Known sick sinus syndrome.
- History of second or third degree AV conduction disturbances.
- Intraventricular conduction disturbances (QRS> 140ms).
- Pacemaker treatment.
- Hemodynamically significant valvular disease.
- Patients with heart failure with symptoms according to NYHA class III or IV.
- Unstable angina pectoris.
- Recent myocardial infarction (< 3 months).
- PTCA, CABG, other cardiac surgery or major non-cardiac surgery within the last three months.
- History of hyperthyroidism or hypothyroidism.
- Serious pulmonary, hepatic, haematological, metabolic, renal, gastrointestinal, CNS or psychiatric disease.
- Pregnant and non-pregnant women who are pre-menopausal and are not practising an acceptable method of contraception.
- Treatment with any other investigational agent.
- Presence of any disease that is likely to shorten life expectancy to < 1 year.
- Any condition that in the opinion of the investigator would jeopardise the evaluation of efficacy or safety or be associated with poor adherence to the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Continuous Versus Episodic Prophylactic Treatment With Oral Amiodarone for the Prevention of Permanent Atrial Fibrillation: a Randomized Study on Morbidity and Quality of Life
Our hypothesis is that episodic amiodarone treatment (i.e. amiodarone treatment 1 month prior until 1 month after cardioversion) is associated with a lower morbidity and a higher quality of life compared to continuous prophylactic amiodarone treatment while atrial fibrillation is still effectively suppressed. The latter means that at the end of the study permanent atrial fibrillation is prevented in comparable percentage of patients (70%) in both treatment strategies. However, this will be accomplished at the cost of a higher number of electrical cardioversions (2-3) in the episodic treatment group compared to the continuous treatment group.
Read the detailed description
Primary objective
To determine differences in adverse event rates between patients with persistent atrial fibrillation who are randomized to episodic amiodarone treatment (EAT) strategy and patients who are randomized to continuous amiodarone treatment (CAT) strategy, while atrial fibrillation is still effectively suppressed.
Adverse events can be related to:
- amiodarone use
- atrial fibrillation itself or underlying heart disease.
Secondary objective
To determine differences in quality of life between patients with persistent atrial fibrillation who are randomized to the EAT strategy and patients who are randomized to the CAT strategy.
- Conditions
- Persistant Atrial Fibrillation
- Being tested
- amiodarone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amiodaroneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events related to amiodarone use and/or atrial fibrillation itself or underlying heart disease
Secondary outcomes (2)
Quality of life
Number of patients with permanent AF at the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2006 (estimated)
- Study startJan 2003
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Persistant 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Netherlands Heart Foundation
- Investigators
- Isabelle C Van Gelder, MD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00392431
- Sponsor's protocol ID
- 2000B133
- Status last verified
- Mar 2007
- First submitted
- 25 Oct 2006
- Last updated
- 22 Mar 2007
- Results posted
- No
Publications
Ahmed S, Ranchor AV, Crijns HJ, Van Veldhuisen DJ, Van Gelder IC; CONVERT investigators. Effect of continuous versus episodic amiodarone treatment on quality of life in persistent atrial fibrillation. Europace. 2010 Jun;12(6):785-91. doi: 10.1093/europace/euq049. Epub 2010 Mar 2.
PubMed 20200016Ahmed S, Rienstra M, Crijns HJ, Links TP, Wiesfeld AC, Hillege HL, Bosker HA, Lok DJ, Van Veldhuisen DJ, Van Gelder IC; CONVERT Investigators. Continuous vs episodic prophylactic treatment with amiodarone for the prevention of atrial fibrillation: a randomized trial. JAMA. 2008 Oct 15;300(15):1784-92. doi: 10.1001/jama.300.15.1784.
PubMed 18854540
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Versus Episodic Prophylactic Treatment With Oral Amiodarone for the Prevention of Permanent Atrial Fibrillation: a Randomized Study on Morbidity and Quality of Life
- ClinicalTrials.gov ID
- NCT00392431
- Acronym / sponsor ID
- 2000B133
- Conditions
- Persistant Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- Netherlands Heart Foundation
- Study start
- Jan 2003
- Study completion
- Mar 2007 (actual)
- First posted
- 26 Oct 2006 (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.
Our hypothesis is that episodic amiodarone treatment (i.e. amiodarone treatment 1 month prior until 1 month after cardioversion) is associated with a lower morbidity and a higher quality of life compared to continuous prophylactic amiodarone treatment while atrial fibrillation is still effectively suppressed. The latter means that at the end of the study permanent atrial fibrillation is prevented in comparable percentage of patients (70%) in both treatment strategies. However, this will be accomplished at the cost of a higher number of electrical cardioversions (2-3) in the episodic treatment group compared to the continuous treatment group.
Detailed description
Primary objective
To determine differences in adverse event rates between patients with persistent atrial fibrillation who are randomized to episodic amiodarone treatment (EAT) strategy and patients who are randomized to continuous amiodarone treatment (CAT) strategy, while atrial fibrillation is still effectively suppressed.
Adverse events can be related to:
- amiodarone use
- atrial fibrillation itself or underlying heart disease.
Secondary objective
To determine differences in quality of life between patients with persistent atrial fibrillation who are randomized to the EAT strategy and patients who are randomized to the CAT strategy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Symptomatic persistent atrial fibrillation for at least 48 hours- 1 year (present episode).
- Older than 18 years of age.
- Ventricular rate during AF > 75 beats per minute, documented on rest-ECG without rate control.
- At least two weeks of oral anticoagulation therapy before screening.
- Written informed consent.
Key exclusion criteria (21 listed)
- Contra indications for amiodarone (severe chronic obstructive pulmonary disease or QTc > 440ms).
- History of relapse of AF during adequate amiodarone treatment (i.e. adequate amiodarone and desethylamiodarone plasma levels).
- Concomitant treatment with class I or III antiarrhythmic drugs. Amiodarone should not have been used during the last 3 months.
- Other (non) cardiac QT prolonging drugs (if not possible to discontinue).
- First episode of persistent atrial fibrillation.
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 |
|---|---|---|
| amiodarone | Drug | – |
Primary outcome
Adverse events related to amiodarone use and/or atrial fibrillation itself or underlying heart disease
2 secondary outcomes
Quality of life
Number of patients with permanent AF at the end of the study
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 22 Mar 2007.
- Derived from this study: PubMed 20200016Ahmed S, Ranchor AV, Crijns HJ, Van Veldhuisen DJ, Van Gelder IC; CONVERT investigators. Effect of continuous versus episodic amiodarone treatment on quality of life in persistent atrial fibrillation. Europace. 2010 Jun;12(6):785-91. doi: 10.1093/europace/euq049. Epub 2010 Mar 2.
- Derived from this study: PubMed 18854540Ahmed S, Rienstra M, Crijns HJ, Links TP, Wiesfeld AC, Hillege HL, Bosker HA, Lok DJ, Van Veldhuisen DJ, Van Gelder IC; CONVERT Investigators. Continuous vs episodic prophylactic treatment with amiodarone for the prevention of atrial fibrillation: a randomized trial. JAMA. 2008 Oct 15;300(15):1784-92. doi: 10.1001/jama.300.15.1784.
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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 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 study testing amiodarone in people with Persistant 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 21 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 22 Mar 2007. 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.
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?
Adverse events related to amiodarone use and/or atrial fibrillation itself or underlying heart disease. 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 NCT00392431, which also lists 2 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 22 Mar 2007.