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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
  Purpose

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


Condition Intervention
Atrial Fibrillation
 Drug: amiodarone
Drug: Dronedarone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Amiodarone Compared to Dronedarone , Post Cardioversion Maintenance of Sinus

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Eastbourne General Hospital:

Primary Outcome Measures:
  • maintenance of sinus rhythm at one year post DC Cardioversion [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 100
Study Start Date: March 2011
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Amiodarone
this group will be given Amiodarone to maintain sinus rhythm powst cardioversion.
 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.
Active Comparator: Dronedarone
this group will be given dronedarone to maintain sinus rhythm post DC cardioversion
 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01266681

Contacts
Contact: Steve Podd, MA, MRCP 01323 417400 ext 4132 steven.podd@esht.nhs.uk

Locations
United Kingdom
Eastbourne General Hospital Not yet recruiting
Eastbourne, East Sussex, United Kingdom, BN21 2UD
Sub-Investigator: Oliver Waller, Bsc (hons)            
Sponsors and Collaborators
Eastbourne General Hospital
  More Information

No publications provided

Responsible Party: Dr Steven Furniss, East Sussex Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT01266681     History of Changes
Other Study ID Numbers: ACDC MainS
Study First Received: December 23, 2010
Last Updated: December 23, 2010
Health Authority: United Kingdon: research ethics committee

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Amiodarone
Anti-Arrhythmia Agents
 Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents

ClinicalTrials.gov processed this record on May 23, 2013