- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01070667
Dronedarone in Pacemakers Patients With Paroxysmal Atrial Fibrillation (DROPPAF)
Dronedarone in Pacemaker Patients With Paroxysmal Atrial Fibrillation
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Steven J Podd, MA, MBBS
- Phone Number: 4132 01323417400
- Email: steven.podd@esht.nhs.uk
Study Contact Backup
- Name: A N Sulke, MD
- Phone Number: 5869 01323417400
- Email: pamela.morley@esht.nhs.uk
Study Locations
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East Sussex
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Eastbourne, East Sussex, United Kingdom, BN21 2UD
- Eastbourne DGH
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Contact:
- Steven J Podd, MA, MBBS
- Phone Number: 4132 01323417400
- Email: steven.podd@esht.nhs.uk
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Contact:
- A N Sulke, MD
- Phone Number: 5869 01323417400
- Email: pamela.morley@esht.nhs.uk
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dronedarone
Patients will receive 400 mg of dronedarone per day for 3 months.
|
400mg orally once per day for 3 months
Other Names:
|
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.
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1 tablet once per day for 3 months.
The tablet will appear identical to the active dronedarone tablet.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To accurately assess the number of AF episodes, AF frequency and average duration of sinus rhythm.
Time Frame: 3 months
|
3 months
|
To assess differences in patient experience of dronedarone and placebo therapies by means of questionnaires.
Time Frame: 3 months
|
3 months
|
Quality of life measures - SF-36, visual analogue scores, symptom assessment scores.
Time Frame: 3 months
|
3 months
|
Comparison of side effects and major adverse cardiac events.
Time Frame: 3 months
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3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: A N Sulke, MD, East Sussex NHS Trust
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DROPPAF V2.1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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