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Dronedarone in Pacemakers Patients With Paroxysmal Atrial Fibrillation (DROPPAF)

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ClinicalTrials.gov Identifier: NCT01070667
Recruitment Status : Unknown
Verified February 2010 by Eastbourne General Hospital.
Recruitment status was:  Not yet recruiting
First Posted : February 18, 2010
Last Update Posted : February 22, 2010
Sponsor:
Information provided by:
Eastbourne General Hospital

Study Description
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Brief Summary:
The purpose of this study is to accurately investigate the efficacy of dronedarone in maintaining sinus rhythm and decreasing AFB in patients with paroxysmal atrial fibrillation as compared with placebo. This has never previously been performed using pacemaker Holter monitoring which provides detailed information of atrial arrhythmia patterns the entire study period. Additionally detailed patient symptom self assessment and questionnaires will be collected. The study design will be double blinded crossover with each phase lasting 3 months.

Condition or disease Intervention/treatment Phase
Paroxysmal Atrial Fibrillation Drug: Dronedarone Drug: Placebo Phase 4

Detailed Description:

The study is planned to commence in March 2010 after obtaining Ethics Committee approval. Patients will be randomised to a three month course of dronedarone or placebo. 1:1 double blinded randomisation will be undertaken. At three months, after a one week washout period, the patients will cross-over treatment groups. To achieve a power of 0.8 with a type one error rate 5% detecting a relative difference of 10% primary outcomes the study will require 42 patients. 50 patients in total will be enrolled in the study. The study will take place at Eastbourne District General Hospital. The study duration per patient is 7 months. The overall study duration will be 1 year.

STUDY OVERVIEW Appropriate patients with DDDRP pacemakers with an AF burden of 1-50% detected on pacemaker holters will be identified from the pacing clinic list and the Cardiology Outpatient Department at the Eastbourne District General Hospital. They will be invited to take part after a verbal explanation of the study has been given. If agreement is obtained each patient will be given the Patient Information Sheet and allowed time to consider their participation in the study and to ask relevant questions. If they are still in agreement they will be asked to sign the Patient Consent Form.

Initially, all patients will have all baseline parameters assessed. All patients will stop taking their anti-arrhythmic drugs for a period of one week. Patients will then have a three month course of either dronedarone or placebo according to randomisation in a double blinded fashion. Randomisation will be performed by use of random number tables. At three months data will be collected from patient questionnaires and pacemaker Holter.

There will be a one week washout period at this time. Patients will then cross-over to dronedarone or placebo for a three month period. Data from patient questionnaires and pacemaker Holters will be collected at three months after cross-over.

Patients will then undergo a further week washout period before re-initiating their original anti-arrhythmic therapy.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Dronedarone in Pacemaker Patients With Paroxysmal Atrial Fibrillation
Study Start Date : March 2010
Estimated Primary Completion Date : March 2010
Estimated Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Dronedarone

Arms and Interventions
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Arm Intervention/treatment
Experimental: Dronedarone
Patients will receive 400 mg of dronedarone per day for 3 months.
 Drug: Dronedarone
400mg orally once per day for 3 months
Other Name: Multaq
Placebo Comparator: Placebo
Patients will receive a placebo tablet once per day for 3 months. AF burden and other parameters described will be monitored from the participants permanent pacemaker. Participants will also be asked to fill out symptom diaries and questionaires.
 Drug: Placebo
1 tablet once per day for 3 months. The tablet will appear identical to the active dronedarone tablet.


Outcome Measures
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Primary Outcome Measures :
  1. To accurately assess, by the use of long term beat to beat pacemaker Holter monitoring, the effect of of dronedarone upon AF burden. [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. To accurately assess the number of AF episodes, AF frequency and average duration of sinus rhythm. [ Time Frame: 3 months ]
  2. To assess differences in patient experience of dronedarone and placebo therapies by means of questionnaires. [ Time Frame: 3 months ]
  3. Quality of life measures - SF-36, visual analogue scores, symptom assessment scores. [ Time Frame: 3 months ]
  4. Comparison of side effects and major adverse cardiac events. [ Time Frame: 3 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with paroxysmal atrial fibrillation (AF burden 1-50% as defined by DDDRP PPM) during the 3 months prior to induction to the study.
  • Patients who have had DDDRP pacemaker implanted for a primary or secondary indication.
  • Patients must be on warfarin.
  • Patients must be over 18 years old.
  • Patients give informed consent form prior to participating in this study.

Exclusion Criteria:

  • Current or previous treatment with amiodarone.
  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01070667


Contacts
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Contact: Steven J Podd, MA, MBBS 01323417400 ext 4132 steven.podd@esht.nhs.uk
Contact: A N Sulke, MD 01323417400 ext 5869 pamela.morley@esht.nhs.uk

Locations
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United Kingdom
Eastbourne DGH
Eastbourne, East Sussex, United Kingdom, BN21 2UD
Contact: Steven J Podd, MA, MBBS    01323417400 ext 4132    steven.podd@esht.nhs.uk   
Contact: A N Sulke, MD    01323417400 ext 5869    pamela.morley@esht.nhs.uk   
Sponsors and Collaborators
Eastbourne General Hospital
Investigators
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Principal Investigator: A N Sulke, MD East Sussex NHS Trust
More Information
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Responsible Party: Dr AN Sulke, East Sussex NHS Trust
ClinicalTrials.gov Identifier: NCT01070667    
Other Study ID Numbers: DROPPAF V2.1
First Posted: February 18, 2010    Key Record Dates
Last Update Posted: February 22, 2010
Last Verified: February 2010
Keywords provided by Eastbourne General Hospital:
PAF
AF
Dronedarone
AF Burden
 AFB
PPM
Permanent Pacemaker
Atrial Fibrillation Burden in Paroxysmal Atrial Fibrillation
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
 Pathologic Processes
Dronedarone
Anti-Arrhythmia Agents