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Amiodarone Compared to Dronedarone , Post Cardioversion Maintenance of Sinus Rhythm (ACDC)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Eastbourne General Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Eastbourne General Hospital
ClinicalTrials.gov Identifier:
NCT01266681
First received: December 23, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted

December 23, 2010
December 23, 2010
March 2011
May 2012   (final data collection date for primary outcome measure)
maintenance of sinus rhythm at one year post DC Cardioversion [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • tolerability of amiodarone compared to dronedarone [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • measures of quality of life and symptoms in amiodarone compared to dronedarone [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Amiodarone Compared to Dronedarone , Post Cardioversion Maintenance of Sinus Rhythm
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

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Atrial Fibrillation
  • Drug: 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.

  • Drug: 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.

  • Active Comparator: Amiodarone
    this group will be given Amiodarone to maintain sinus rhythm powst cardioversion.
    Intervention: Drug: amiodarone
  • Active Comparator: Dronedarone
    this group will be given dronedarone to maintain sinus rhythm post DC cardioversion
    Intervention: Drug: Dronedarone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
100
Not Provided
May 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Steve Podd, MA, MRCP 01323 417400 ext 4132 steven.podd@esht.nhs.uk
United Kingdom
 
NCT01266681
ACDC MainS
Yes
Dr Steven Furniss, East Sussex Hospitals NHS Trust
Eastbourne General Hospital
Not Provided
Not Provided
Eastbourne General Hospital
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP