Amiodarone Compared to Dronedarone , Post Cardioversion Maintenance of Sinus Rhythm (ACDC)
Primary Purpose
Atrial Fibrillation
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
amiodarone
Dronedarone
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
• 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.
Exclusion Criteria:
• 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.
- 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
Sites / Locations
- Eastbourne General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Amiodarone
Dronedarone
Arm Description
this group will be given Amiodarone to maintain sinus rhythm powst cardioversion.
this group will be given dronedarone to maintain sinus rhythm post DC cardioversion
Outcomes
Primary Outcome Measures
maintenance of sinus rhythm at one year post DC Cardioversion
Secondary Outcome Measures
tolerability of amiodarone compared to dronedarone
measures of quality of life and symptoms in amiodarone compared to dronedarone
Full Information
NCT ID
NCT01266681
First Posted
December 23, 2010
Last Updated
December 23, 2010
Sponsor
Eastbourne General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01266681
Brief Title
Amiodarone Compared to Dronedarone , Post Cardioversion Maintenance of Sinus Rhythm
Acronym
ACDC
Official Title
Amiodarone Compared to Dronedarone , Post Cardioversion Maintenance of Sinus
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Unknown status
Study Start Date
March 2011 (undefined)
Primary Completion Date
May 2012 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Eastbourne General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Amiodarone
Arm Type
Active Comparator
Arm Description
this group will be given Amiodarone to maintain sinus rhythm powst cardioversion.
Arm Title
Dronedarone
Arm Type
Active Comparator
Arm Description
this group will be given dronedarone to maintain sinus rhythm post DC cardioversion
Intervention Type
Drug
Intervention Name(s)
amiodarone
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Dronedarone
Intervention Description
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.
Primary Outcome Measure Information:
Title
maintenance of sinus rhythm at one year post DC Cardioversion
Time Frame
1 year
Secondary Outcome Measure Information:
Title
tolerability of amiodarone compared to dronedarone
Time Frame
1 year
Title
measures of quality of life and symptoms in amiodarone compared to dronedarone
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
• 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.
Exclusion Criteria:
• 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.
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Steve Podd, MA, MRCP
Phone
01323 417400
Ext
4132
Email
steven.podd@esht.nhs.uk
Facility Information:
Facility Name
Eastbourne General Hospital
City
Eastbourne
State/Province
East Sussex
ZIP/Postal Code
BN21 2UD
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oliver Waller, Bsc (hons)
12. IPD Sharing Statement
Learn more about this trial
Amiodarone Compared to Dronedarone , Post Cardioversion Maintenance of Sinus Rhythm
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