DROPPAF
Research type
Research Study
Full title
Dronedarone in pacemaker patients with paroxysmal atrial fibrillation
IRAS ID
44344
Contact name
AN Sulke
Sponsor organisation
Research Department
Eudract number
2010-019442-87
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to accurately investigate the effect of a new drug (dronedarone) in maintaining a normal heart rhythm in patients with an intermittently irregular pulse (paroxysmal atrial fibrillation). Dronedarone is a novel drug that is designed to suppress atrial fibrillation but, unlike similiar medication, without serious side effects. The study aims to recruit potential participants who already have a pacemaker and who have trouble with paroxysmal atrial fibrillation (usual symptoms are shortness of breath, dizzyness and palpitations). This has never previously been performed using a pacemaker to monitor the heart rhythm which provides detailed and continuous information of the heart rhythm for the entire study period. Additionally detailed participant symptom self assessment and questionnaires will be collected. The study is designed to last 6 months. Initially half of the participants will receive the dronedarone drug and half a placebo tablet (a sugar tablet). After 3 months the participants will swap over their treatment ?? i.e. those taking dronedarone will take placebo and vice versa. Neither the doctor nor the participant will know which treatment they are taking and allocation to each group will be random i.e. the study is a double blinded randomised crossover trial. At the end of each 3 month period the pacemaker will be examined and the questionaires and symptom assessments collected to find out exactly how effective the treatment has been.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
10/H0406/22
Date of REC Opinion
30 Apr 2010
REC opinion
Further Information Favourable Opinion