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Amiodarone Compared to Dronedarone , Post Cardioversion Maintenance of Sinus Rhythm

Information source: Eastbourne General Hospital
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Atrial Fibrillation

Intervention: amiodarone (Drug); Dronedarone (Drug)

Phase: N/A

Status: Not yet recruiting

Sponsored by: Eastbourne General Hospital

Overall contact:
Steve Podd, MA, MRCP, Phone: 01323 417400, Ext: 4132, Email: steven.podd@esht.nhs.uk

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

Clinical Details

Official title: Amiodarone Compared to Dronedarone , Post Cardioversion Maintenance of Sinus

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

Primary outcome: maintenance of sinus rhythm at one year post DC Cardioversion

Secondary outcome:

tolerability of amiodarone compared to dronedarone

measures of quality of life and symptoms in amiodarone compared to dronedarone

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Steve Podd, MA, MRCP, Phone: 01323 417400, Ext: 4132, Email: steven.podd@esht.nhs.uk

Eastbourne General Hospital, Eastbourne, East Sussex BN21 2UD, United Kingdom; Not yet recruiting
Oliver Waller, Bsc (hons), Sub-Investigator
Additional Information

Starting date: March 2011
Last updated: December 23, 2010

Page last updated: February 07, 2013

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