Amiodarone Compared to Dronedarone , Post Cardioversion Maintenance of Sinus Rhythm

Atrial Fibrillation Clinical Trial

— ACDC  

Official title:

Amiodarone Compared to Dronedarone , Post Cardioversion Maintenance of Sinus

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01266681
• Other study ID #: ACDC MainS
• Status: Not yet recruiting
• Phase: N/A
• First received: December 23, 2010
• Last updated: December 23, 2010
• Start date: March 2011

Study information

• Verified date: November 2010
• Source: Eastbourne General Hospital
• Contact: Steve Podd, MA, MRCP
• Phone: 01323 417400
• Email: steven.podd[@]esht.nhs.uk
• Is FDA regulated: No
• Health authority: United Kingdon: research ethics committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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.
• 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.

Locations

Country	Name	City	State
United Kingdom	Eastbourne General Hospital	Eastbourne	East Sussex

Sponsors (1)

Lead Sponsor	Collaborator
Eastbourne General Hospital

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	maintenance of sinus rhythm at one year post DC Cardioversion		1 year	No
Secondary	tolerability of amiodarone compared to dronedarone		1 year	No
Secondary	measures of quality of life and symptoms in amiodarone compared to dronedarone		1 year	No