Amiodarone Compared to Dronedarone , Post Cardioversion Maintenance of Sinus Rhythm

NCT01266681 | Unknown DMC

• 1 other identifier: ACDC MainS
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• maintenance of sinus rhythm at one year post DC Cardioversion

  1 year

Secondary Outcomes (2)

• tolerability of amiodarone compared to dronedarone

  1 year

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

  1 year

Study Arms (2)

Amiodarone

ACTIVE COMPARATOR

this group will be given Amiodarone to maintain sinus rhythm powst cardioversion.

Drug: amiodarone

Dronedarone

ACTIVE COMPARATOR

this group will be given dronedarone to maintain sinus rhythm post DC cardioversion

Drug: Dronedarone

Interventions

amiodarone DRUG

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.

Amiodarone

Dronedarone DRUG

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.

Dronedarone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Eastbourne General Hospital: lead

Study Sites (1)

Eastbourne General Hospital

Eastbourne, East Sussex, BN21 2UD, United Kingdom

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Amiodarone; Dronedarone

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Steve Podd, MA, MRCP

CONTACT

01323 417400; steven.podd@esht.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 23, 2010
• First Posted: December 24, 2010
• Study Start: March 1, 2011
• Primary Completion: May 1, 2012
• Last Updated: December 24, 2010

Record last verified: 2010-11

Locations

GB (1)