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ISRCTN
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ISRCTN28131679
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ClinicalTrials.gov identifier
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Public title
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Safety and efficacy of procainamide and amiodarone in the treatment of atrial fibrillation of recent onset
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Scientific title
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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To study whether procainamide and amiodarone are both effective after digoxin administration to restore sinus rhythm
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Lay summary
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Ethics approval
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Approved by the University
of Athens on 4/5/1998, reference number 78/1998
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Study design
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Randomised double-blind controlled trial
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Countries of recruitment
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Greece
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Disease/condition/study domain
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Atrial fibrillation
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Participants - inclusion criteria
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Atrial fibrillation of recent onset (less than 24 hours)
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Participants - exclusion criteria
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1. Age <18 years
2. Baseline systolic blood pressure <100 mmHg
3. Known thyroid disease
4. Serum potassium <3.5 mmol/l
5. Pre-treatment with any anti-arrhythmic drug
6. Documented permanent AF, atrial flutter and a corrected heart rate (QTc) interval >440 msec
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Anticipated start date
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05/05/1998
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Anticipated end date
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20/08/2003
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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225
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Interventions
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After administration of digitalis (digoxin), and in case of failure to restore Sinus Rhythm (SR), the patients were randomized into two groups. Randomization was performed with the use of sealed envelopes, thus guaranteeing an almost equal number of patients.
Group A (113 patients) received amiodarone intravenously 300 mg in 30 minutes and in case of failure to restore SR, amiodarone was continued for a further 24 hours as an intravenous infusion (maintenance) of 20 mg/kg.
Group B (110 patients) were administered a bolus dose of 1 g intravenous procainamide, and in the case of failure to restore sinus rhythm in 30 minutes, 2 mg/min (maintenance) for the next 24 hours. The other two participants decided to be treated privately, therefore both received digitalis and the study medication, but did not stay in the NHS long enough to be included in the study.
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Primary outcome measure(s)
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Restoration of sinus rhythm
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Secondary outcome measure(s)
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1. Time of cardioversion
2. Blood pressure fluctuations
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Sources of funding
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Greek National Health Service (Greece)
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Trial website
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Publications
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2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17653020
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Contact name
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Dr
Theodoros
Xanthos
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Address
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15B Agiou Thoma street
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City/town
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Athens
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Zip/Postcode
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11527
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Country
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Greece
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Email
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theodorosxanthos@yahoo.com
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Sponsor
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Greek National Health Service (Greece)
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Address
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15B Agiou Thoma street
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City/town
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Athens
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Zip/Postcode
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11527
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Country
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Greece
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Tel
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+30 (0) 2106972221
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Email
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lilapapadimitriou@hotmail.com
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Date applied
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23/02/2006
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Last edited
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25/09/2009
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Date ISRCTN assigned
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08/03/2006
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