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

Sponsor

Eastbourne General Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01266681

Collaborator

(none)

100

Enrollment

Location

Arms

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Drug: amiodarone Drug: Dronedarone	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Amiodarone Compared to Dronedarone , Post Cardioversion Maintenance of Sinus

Study Start Date :

Mar 1, 2011

Anticipated Primary Completion Date :

May 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

maintenance of sinus rhythm at one year post DC Cardioversion [1 year]

Secondary Outcome Measures

tolerability of amiodarone compared to dronedarone [1 year]
measures of quality of life and symptoms in amiodarone compared to dronedarone [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Eastbourne General Hospital	Eastbourne	East Sussex	United Kingdom	BN21 2UD

Sponsors and Collaborators

Eastbourne General Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01266681

Other Study ID Numbers:

ACDC MainS

First Posted:

Dec 24, 2010

Last Update Posted:

Dec 24, 2010

Last Verified:

Nov 1, 2010

Additional relevant MeSH terms:

Atrial Fibrillation

Amiodarone

Dronedarone

Study Results

No Results Posted as of Dec 24, 2010