Atrial FibrillationACDCNCT01266681
Amiodarone Compared to Dronedarone , Post Cardioversion Maintenance of Sinus Rhythm
A study testing amiodarone and Dronedarone in people with Atrial Fibrillation, run by East Sussex Healthcare NHS Trust at 1 site in United Kingdom.
Trial summary
Persistent Atrial Fibrillation (AF) is a common and distressing cardiac arrhythmia and accounts for 1% of the healthcare budget in the UK and it's prevalence is rising. Symptoms of atrial fibrillation include palpitations, chest pain , shortness of breath and fatigue, with quality of life measures reduced for patients… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- amiodarone and Dronedarone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2011to May 2012
- 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
- • Patients with persAF requiring dc cardioversion.
- Patients must be over 18 years old.
- Patients give informed consent form prior to participating in this study.
- Patients must be on warfarin for at least 4 weeks or a transoesphageal ECHO must be performed at the time of dc cardioversion.
Who cannot join
- • Patient is suffering with unstable angina in last 1 week.
- Patient has had a myocardial infarction within last 2 months.
- Patient is expecting or has had major cardiac surgery within last 2 months.
- Patient is participating in a conflicting study.
- Patient is mentally incapacitated and cannot consent or comply with follow-up.
- Patient has NYHA class III/ IV heart failure.
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- Pregnancy.
- Patient suffers with other cardiac rhythm disorders.
- Recent coronary artery intervention or other factors suggesting clinical instability (ECG, clinical or laboratory findings).
- GFR<30mls/min.
- Patients has a contraindication to amiodarone or dronedarone
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Eastbourne General Hospital
Eastbourne, East Sussex, BN21 2UD
Oliver Waller, Bsc (hons)
About this study
Official title: Amiodarone Compared to Dronedarone , Post Cardioversion Maintenance of Sinus
Persistent Atrial Fibrillation (AF) is a common and distressing cardiac arrhythmia and accounts for 1% of the healthcare budget in the UK and it's prevalence is rising. Symptoms of atrial fibrillation include palpitations, chest pain , shortness of breath and fatigue, with quality of life measures reduced for patients with persistent AF, increased stroke risk and increased all cause mortality rates. DC Cardioversion is used to restore normal sinus rhythm in patients with persistent AF. It has a high success rate but reoccurence of AF is common. The use of anti arrhythmic drugs (AADs) can augment the number of patients remaining in sinus rhythm at one year, with amiodarone currently the most superior. Unfortunately it can have serious side affects. Dronedarone is a related drug designed specifically to minimise the most serious side affects and is no approved and used prominently in the management of non permanent AF. However it has not yet been studied in a post DC Cardioversion population.
Patients in persistent AF who are referred for elective DC Cardioversionwill be randomised to receive either Amiodarone or Dronedarone to compare the ability to help maintain sinu rhythm post cardioverion in one NHS hospital. Patients will be followed up for a year post cardioversion to see if they stay in sinus rhythm.
Ho: there will be no difference in maintenance of sinus rhythm with the use of amiodarone or dronedarone
- Conditions
- Atrial Fibrillation
- Being tested
- amiodarone, Dronedarone
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amiodaroneDrug
Visit One:. Once consent is given patarticipants will be randomised into either group and instructed and prescribed the drug as appropriate.
Visit Two: Patients will attend for routine cardioversion. This is performed by an experienced CCU nurse as per normal protocol. Patients will also undergo an ECG, and fill in symptom and quality of life (QoL) questionnaires.
Visit Three: Patients will attend a routine outpatient appointment 6 weeks post cardioversion. They will undergo ECG and fill in symptom and QoL questionnaires
Visit Four: Participants will attend at 12 weeks for ECG, symptom and QoL questionnaires
Visit Five: Participants will attend at 24 weeks for ECG, symptom and QoL questionnaires
Visit Six: Participants will attend at 36 weeks for ECG, symptom and QoL questionnaires
Visit Seven: Participants will attend at 52 weeks for ECG, symptom and QoL questionnaires. Participants will then be followed up as per protocol by their consultant cardiologist.
DronedaroneDrug
Visit One: patarticipants will be randomised into either group and instructed and prescribed the drug as appropriate.
Visit Two: Patients will attend for routine cardioversion. This is performed by an experienced CCU nurse as per normal protocol. Patients will also undergo an ECG, and fill in symptom and quality of life (QoL) questionnaires.
Visit Three: Patients will attend a routine outpatient appointment 6 weeks post cardioversion. They will undergo ECG and fill in symptom and QoL questionnaires
Visit Four: Participants will attend at 12 weeks for ECG, symptom and QoL questionnaires
Visit Five: Participants will attend at 24 weeks for ECG, symptom and QoL questionnaires
Visit Six: Participants will attend at 36 weeks for ECG, symptom and QoL questionnaires
Visit Seven: Participants will attend at 52 weeks for ECG, symptom and QoL questionnaires. Participants will then be followed up as per protocol by their consultant cardiologist.
| Study group | Role | What they receive |
|---|---|---|
| Amiodarone | Active comparator | this group will be given Amiodarone to maintain sinus rhythm powst cardioversion. Receives: Drug: amiodarone |
| Dronedarone | Active comparator | this group will be given dronedarone to maintain sinus rhythm post DC cardioversion Receives: Drug: Dronedarone |
What is being measured
The primary outcome is the main question the study is designed to answer.
maintenance of sinus rhythm at one year post DC Cardioversion
Measured: 1 year
Secondary outcomes (2)
tolerability of amiodarone compared to dronedarone
Measured: 1 year
measures of quality of life and symptoms in amiodarone compared to dronedarone
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2010 (estimated)
- Study startMar 2011
- Primary completionMay 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- East Sussex Healthcare NHS Trust
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01266681
- Sponsor's protocol ID
- ACDC MainS
- Acronym
- ACDC
- Status last verified
- Nov 2010
- First submitted
- 23 Dec 2010
- Last updated
- 24 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amiodarone Compared to Dronedarone , Post Cardioversion Maintenance of Sinus
- ClinicalTrials.gov ID
- NCT01266681
- Acronym / sponsor ID
- ACDC / ACDC MainS
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- East Sussex Healthcare NHS TrustUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- May 2012 (estimated)
- First posted
- 24 Dec 2010 (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.
Persistent Atrial Fibrillation (AF) is a common and distressing cardiac arrhythmia and accounts for 1% of the healthcare budget in the UK and it's prevalence is rising. Symptoms of atrial fibrillation include palpitations, chest pain , shortness of breath and fatigue, with quality of life measures reduced for patients with persistent AF, increased stroke risk and increased all cause mortality rates. DC Cardioversion is used to restore normal sinus rhythm in patients with persistent AF. It has a high success rate but reoccurence of AF is common. The use of anti arrhythmic drugs (AADs) can augment the number of patients remaining in sinus rhythm at one year, with amiodarone currently the most superior. Unfortunately it can have serious side affects. Dronedarone is a related drug designed specifically to minimise the most serious side affects and is no approved and used prominently in the management of non permanent AF. However it has not yet been studied in a post DC Cardioversion population.
Patients in persistent AF who are referred for elective DC Cardioversionwill be randomised to receive either Amiodarone or Dronedarone to compare the ability to help maintain sinu rhythm post cardioverion in one NHS hospital. Patients will be followed up for a year post cardioversion to see if they stay in sinus rhythm.
Ho: there will be no difference in maintenance of sinus rhythm with the use of amiodarone or dronedarone
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amiodarone | Active comparator | Drug: amiodaronethis group will be given Amiodarone to maintain sinus rhythm powst cardioversion. |
| Dronedarone | Active comparator | Drug: Dronedaronethis group will be given dronedarone to maintain sinus rhythm post DC cardioversion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- • Patients with persAF requiring dc cardioversion.
Key exclusion criteria (11 listed)
- • Patient is suffering with unstable angina in last 1 week.
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 |
|---|---|---|
| amiodaroneVisit One:. Once consent is given patarticipants will be randomised into either group and instructed and prescribed the drug as appropriate. Visit Two: Patients will attend for routine cardioversion. This is performed by an experienced CCU nurse as per normal protocol. Patients will also undergo an ECG, and fill in symptom and quality of life (QoL) questionnaires. Visit Three: Patients will attend a routine outpatient appointment 6 weeks post cardioversion. They will undergo ECG and fill in symptom and QoL questionnaires Visit Four: Participants will attend at 12 weeks for ECG, symptom and QoL questionnaires Visit Five: Participants will attend at 24 weeks for ECG, symptom and QoL questionnaires Visit Six: Participants will attend at 36 weeks for ECG, symptom and QoL questionnaires Visit Seven: Participants will attend at 52 weeks for ECG, symptom and QoL questionnaires. Participants will then be followed up as per protocol by their consultant cardiologist. | Drug | Amiodarone |
| DronedaroneVisit One: patarticipants will be randomised into either group and instructed and prescribed the drug as appropriate. Visit Two: Patients will attend for routine cardioversion. This is performed by an experienced CCU nurse as per normal protocol. Patients will also undergo an ECG, and fill in symptom and quality of life (QoL) questionnaires. Visit Three: Patients will attend a routine outpatient appointment 6 weeks post cardioversion. They will undergo ECG and fill in symptom and QoL questionnaires Visit Four: Participants will attend at 12 weeks for ECG, symptom and QoL questionnaires Visit Five: Participants will attend at 24 weeks for ECG, symptom and QoL questionnaires Visit Six: Participants will attend at 36 weeks for ECG, symptom and QoL questionnaires Visit Seven: Participants will attend at 52 weeks for ECG, symptom and QoL questionnaires. Participants will then be followed up as per protocol by their consultant cardiologist. | Drug | Dronedarone |
Primary outcome
maintenance of sinus rhythm at one year post DC Cardioversion
Time frame: 1 year
2 secondary outcomes
tolerability of amiodarone compared to dronedarone
Time frame: 1 year
measures of quality of life and symptoms in amiodarone compared to dronedarone
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2010.
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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.
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 and Dronedarone in people with Atrial Fibrillation, run by East Sussex Healthcare NHS Trust at 1 site in United Kingdom.
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 4 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 24 Dec 2010. 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Steve Podd, MA, MRCP (01323 417400 ext. 4132, steven.podd@esht.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maintenance of sinus rhythm at one year post DC Cardioversion (time frame: 1 year). 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 Dec 2010.