Amiodarone Compared to Dronedarone , Post Cardioversion Maintenance of Sinus Rhythm
NCT ID: NCT01266681
Last Updated: 2010-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2011-03-31
Brief Summary
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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
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Amiodarone
this group will be given Amiodarone to maintain sinus rhythm powst cardioversion.
amiodarone
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.
Dronedarone
this group will be given dronedarone to maintain sinus rhythm post DC cardioversion
Dronedarone
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.
Interventions
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amiodarone
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.
Dronedarone
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
* 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
18 Years
ALL
No
Sponsors
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Eastbourne General Hospital
OTHER
Responsible Party
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East Sussex Hospitals NHS Trust
Locations
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Eastbourne General Hospital
Eastbourne, East Sussex, United Kingdom
Countries
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Central Contacts
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Other Identifiers
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ACDC MainS
Identifier Type: -
Identifier Source: org_study_id