To demonstrate that dronedarone is superior to amiodarone in the maintenance of sinus rhythm after pharmacological, electrical or spontaneous conversion of AF.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Treatment failure defined as recurrence of AF or premature study drug
discontinuation for intolerance or lack of efficacy.
Secondary outcome
There are no secundary endpoints defined in the protocol.
Background summary
Atrial fibrillation (AF) is the most frequent sustained arrhythmia in elderly
people. It is associated with an increase in mortality risk and the symptoms
can lead to heart failure and embolic complications. It is therefore common
practice to restore sinus rhythm and to prevent AF recurrence.
Study objective
To demonstrate that dronedarone is superior to amiodarone in the maintenance of
sinus rhythm after pharmacological, electrical or spontaneous conversion of AF.
Study design
Randomised, double blind.
Intervention
Patients will be treated with either amiodarone or dronedarone.
Amiodarone will have a loading dose of 600 mg per day and after 28 days this
will decrease to 200 mg. Dronedarone will be administered 400 mg twice daily.
Study burden and risks
The patient will perform maximally 11 study visits during a maximal treatment
period of 1 year. During the screening period, the patient will undergo the
following examinations: ECG, chest X-ray, pulmonary function test and blood
drawing.
During the remaining visits, the patient will undergo the following
examinations: ECG, measurement of blood pressure and blood drawing.
The chest X-ray will be repeated at the M6 and EOT visits.
The risks are possible amiodarone or dronedarone side effects.
The general tolerability of 400 mg twice daily was good and the most frequent
adverse events repored were gastrointestinal disorders (mainly diarrhea). Other
adverse events which could be slightly increased are skin disorders, blood
disorders (mainly anemia) and psychological disorders (mainly sleeping
disorders).
Amiodarone side effects can be gastrointestinal disorders such as nausea,
vomiting or constipation, excessive slowing of heart rate, thyroid disorders
like hypothyroidism and hyperthyroidism, liver enzyme elevation, sleep
disorders, skin disorders like sensitivity to sunburning more rarely grey
bluish pigmentation, vision problems: blurred vision, halos, or eyes become
light sensitive, numbness or 'pins and needles' in arms or legs, muscle
weakness, uncontrolled movements, tremor, poor coordination and difficulty
walking, increased bleeding.
Kampenringweg 45 D-E
2803 PE Gouda
NL
Kampenringweg 45 D-E
2803 PE Gouda
NL
Listed location countries
Age
Inclusion criteria
- Patients with documented AF for more than 72 hours for whom cardioversion and antiarrhythmic treatment is indicated in the opinion of the Investigator and receiving anticoagulants,
- Signed informed consent for the study.
Exclusion criteria
- Patients aged below 21 years,
- Contraindication to oral anticoagulation,
- Patient having received amiodarone in the past whatever the date (more than a total of twenty 200 mg tablets or more than 5 days intravenous [IV]),
- Women of childbearing potential without adequate birthcontrol; pregnant women; breastfeeding women,
- Clinically relevant haematologic, hepatic, gastrointestinal, renal, pulmonary, endocrinologic, psychiatric, neurological or dermatological disease,
- Serum potassium < 3.5 mmol/l and uncorrected or > 5.5 mmol/l before randomization,
- History of torsades de pointes; first degree family history of sudden cardiac death below age 50 years in the absence of coronary heart disease,
- History of high degree atrio-ventricular block (2nd degree Mobitz 2 or higher), or significant sinus node disease (documented pause of 3 sec or more) without a permanent pacemaker implanted,
- Bradycardia < 50 beats per minute (bpm) on the last 12-lead electrocardiogram (ECG) before randomization,
- Clinically overt congestive heart failure with NYHA class III or IV at the time of randomization,
- Ongoing potentially dangerous symptoms when in AF such as angina pectoris, transient ischemic attacks, stroke, syncope, as judged by the investigator,
- Patients known to have chronic AF defined as continuous AF for more than 12 months,
- Long QT syndrome or QT- or QTc-interval > or = 500 msecs before randomization,
- Wolff-Parkinson-White Syndrome,
- Patients with atrial flutter; patients with paroxysmal AF,
- Hyperthyroidism; hypothyroidism; other contraindications to amiodarone,
- Treatment with other Class I or III antiarrhythmic drugs.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2006-005804-15-NL |
| CCMO | NL16794.044.07 |