A Phase 3 interventional study of Amiodarone and Placebo in Atrial Fibrillation, sponsored by Rambam Health Care Campus. Status unknown. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2016-03-22.
Sponsored by Rambam Health Care Campus · Phase 3, Interventional, and Prevention
Post-operative atrial fibrillation (POAF) is the most common complication encountered after cardiac surgery; reports show POAF to occur in \~ 35% of patients after CABG. Prophylactic use amiodarone was found to be effective, however, due to serious extracardiac adverse effects therapy is probably appropriate just for patients at high risk for POAF.
the common practice for management of POAF is treatment with intravenous Amiodarone until return to sinus rhythm, following which the drug is given orally. Our protocol involves continued treatment with amiodarone for 30 day post-discharge from the hospital in a dose of 200mg per day.
This protocol is a common practice in many cardiac surgical departments worldwide, nevertheless, it is not evidence-based protocol and it was never examined as such.
This study is a randomized placebo controlled trial, to evaluate the requirement for post-discharge treatment with oral Amiodarone.
Atrial fibrillation (AF) is the most widespread complication encountered after cardiac surgery, associated with prolonged hospitalization, morbidity, mortality, and an annual cost of more than $1 billion to the American healthcare system.
AF has been reported to predict postoperative stroke, congestive heart failure, and late AF among patients undergoing mitral valve surgery. Postoperative AF (POAF) occurs in 62% of patients undergoing combined aortic valve and coronary artery bypass graft (CABG) surgery, in 49% of patients undergoing aortic valve surgery alone, in 42% of patients undergoing mitral valve surgery, and in 32% of patients undergoing CABG surgery alone. These figures are expected to rise in the future, given that the patients undergoing cardiac surgery are getting elder and that the incidence of AF in the general population is markedly age-dependent.
POAF peak incidence occurs on the 2nd and 3rd postoperative days (PODs). Seventy percent of patients develop this arrhythmia before the end of the 4th POD and 94% before the end of the 6th. Although generally well-tolerated and seen as a temporary problem related to surgery, POAF can be life-threatening, particularly in elderly patients and those with left ventricular dysfunction.
Recent guidelines for the prevention and management of POAF were jointly published in 2006 by the American College of Cardiology, the American Heart Association (AHA), and the European Society of Cardiology. These guidelines recommended (i) preoperative treatment with an oral beta-blocker drug for prevention of POAF as a class IA indication, and (ii) preoperative administration of amiodarone for patients at a high risk for POAF as a class IIA indication.
Amiodarone is associated with several complications, both cardiac, and extracardiac; among the cardiac complications, it is predominantly related to increased risk of bradycardia and hypotension, particularly when (i) administered intravenously, (ii) using average daily doses exceeding 1 g, and (iii) initiating prophylaxis during the postoperative period.45 Among the most severe extracardiac complications, amiodarone is associated with thyroid toxicity, lung fibrosis, and corneal damage, which may be aggravated by the drug's delayed onset of action (2 - 3 days) and long elimination half-life time (up to 6 months).
Currently the common practice for management of POAF is treatment with intravenous Amiodarone until return to sinus rhythm, following which the drug is given orally. Our protocol involves continued treatment with amiodarone for 30 day post-discharge from the hospital in a dose of 200mg per day.
This protocol is a common practice in many cardiac surgical departments worldwide, nevertheless, it is not evidence-based protocol and it was never examined as such.
This study is a randomized placebo controlled trial, to evaluate the requirement for post-discharge treatment with oral Amiodarone.
3,957 studies on the registry are indexed under Atrial Fibrillation; 933 are open to participants now.
This study's planned enrollment of 400 is above the median of 145 across 2,437 interventional studies indexed under Atrial Fibrillation.
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Exclusion Criteria:
Will receive 30 days treatment with oral placebo of 200mg
Drug: Placebo
Will receive 30 days treatment with oral Amiodarone of 200mg
Drug: Amiodarone
Will receive 30 days treatment with oral amniodarone of 200mg
Also known as: amiodacore
Will receive 30 days treatment with oral placebo of 200mg
Postoperative atrial fibrillation
Post-discharge monitoring with a continous loop-recorder type of ECG monitoring device named "CardioR" will be provided for all participants. The device will continuously record and transmit ECG monitoring to a dedicated monitoring company. All arrhythmias will be recorded and reported.
Time frame: 30 days after discharge
Post-discharge return to admission
Any return to admission will be recorded and reported.
Time frame: 30 days after discharge
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
The record gives a start of Mar 2016, a primary completion of Dec 2017 and a completion of Dec 2018. It does not say whether these dates are actual or estimated.
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This study is status unknown, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Amiodarone