drugset / Trial / NCT03432663
Time-dependent Amiodarone Treatment in Atrial Fibrillation
Phase 4
Completed
60 enrolled
Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec Salud
RandomizedParallel-groupSingle-blindTreatment
Summary
Sixty consecutive emergency patients with newly diagnosed Atrial Fibrillation were randomized into two groups. The first received intravenous amiodarone infusions continuously for 24 hours; the second received Amiodarone until sinus rhythms was reached or for up to 72 hours. The efficacy and safety of administering intravenous infusions of amiodarone for up to 72 hours were investigated and compared to the efficacy and safety of administering a standard 24 hours infusion of amiodarone. Specifically, the use of up to 72 hours infusions was considered as a new strategy to improve rates of conversion to sinus rhythm without altering the safety profile of the drug.
Timeline
- Start
- 2008-08-01
- Primary completion
- 2009-11-30
- Completion
- 2009-11-30
Publications
- Background Cotter G, Blatt A, Kaluski E, Metzkor-Cotter E, Koren M, Litinski I, Simantov R, Moshkovitz Y, Zaidenstein R, Peleg E, Vered Z, Golik A. Conversion of recent onset paroxysmal atrial fibrillation to normal sinus rhythm: the effect of no treatment and high-dose amiodarone. A randomized, placebo-controlled study. Eur Heart J. 1999 Dec;20(24):1833-42. doi: 10.1053/euhj.1999.1747.
- Background Snow V, Weiss KB, LeFevre M, McNamara R, Bass E, Green LA, Michl K, Owens DK, Susman J, Allen DI, Mottur-Pilson C; AAFP Panel on Atrial Fibrillation; ACP Panel on Atrial Fibrillation. Management of newly detected atrial fibrillation: a clinical practice guideline from the American Academy of Family Physicians and the American College of Physicians. Ann Intern Med. 2003 Dec 16;139(12):1009-17. doi: 10.7326/0003-4819-139-12-200312160-00011.
- Background Joseph AP, Ward MR. A prospective, randomized controlled trial comparing the efficacy and safety of sotalol, amiodarone, and digoxin for the reversion of new-onset atrial fibrillation. Ann Emerg Med. 2000 Jul;36(1):1-9. doi: 10.1067/mem.2000.107655.
- Background Tuseth V, Jaatun HJ, Dickstein K. Amiodarone infusion in the treatment of acute atrial fibrillation or flutter: high versus low dose treatment. Heart. 2005 Jul;91(7):964-5. doi: 10.1136/hrt.2004.049171. No abstract available.
- Background Waldo AL. Management of atrial fibrillation: the need for AFFIRMative action. AFFIRM investigators. Atrial Fibrillation Follow-up Investigation of Rhythm Management. Am J Cardiol. 1999 Sep 15;84(6):698-700. doi: 10.1016/s0002-9149(99)00419-1. No abstract available.
- Background Wyse DG, Waldo AL, DiMarco JP, Domanski MJ, Rosenberg Y, Schron EB, Kellen JC, Greene HL, Mickel MC, Dalquist JE, Corley SD; Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM) Investigators. A comparison of rate control and rhythm control in patients with atrial fibrillation. N Engl J Med. 2002 Dec 5;347(23):1825-33. doi: 10.1056/NEJMoa021328.
- Background Go AS, Hylek EM, Phillips KA, Chang Y, Henault LE, Selby JV, Singer DE. Prevalence of diagnosed atrial fibrillation in adults: national implications for rhythm management and stroke prevention: the AnTicoagulation and Risk Factors in Atrial Fibrillation (ATRIA) Study. JAMA. 2001 May 9;285(18):2370-5. doi: 10.1001/jama.285.18.2370.
- Background Benjamin EJ, Wolf PA, D'Agostino RB, Silbershatz H, Kannel WB, Levy D. Impact of atrial fibrillation on the risk of death: the Framingham Heart Study. Circulation. 1998 Sep 8;98(10):946-52. doi: 10.1161/01.cir.98.10.946.
- Background Vaziri SM, Larson MG, Benjamin EJ, Levy D. Echocardiographic predictors of nonrheumatic atrial fibrillation. The Framingham Heart Study. Circulation. 1994 Feb;89(2):724-30. doi: 10.1161/01.cir.89.2.724.
- Background Kumana CR, Cheung BM, Cheung GT, Ovedal T, Pederson B, Lauder IJ. Rhythm vs. rate control of atrial fibrillation meta-analysed by number needed to treat. Br J Clin Pharmacol. 2005 Oct;60(4):347-54. doi: 10.1111/j.1365-2125.2005.02449.x.
- Background Lim HS, Hamaad A, Lip GY. Clinical review: clinical management of atrial fibrillation - rate control versus rhythm control. Crit Care. 2004 Aug;8(4):271-9. doi: 10.1186/cc2827. Epub 2004 Feb 19.
- Background Chevalier P, Durand-Dubief A, Burri H, Cucherat M, Kirkorian G, Touboul P. Amiodarone versus placebo and class Ic drugs for cardioversion of recent-onset atrial fibrillation: a meta-analysis. J Am Coll Cardiol. 2003 Jan 15;41(2):255-62. doi: 10.1016/s0735-1097(02)02705-5.
- Background Hauser TH, Pinto DS, Josephson ME, Zimetbaum P. Early recurrence of arrhythmia in patients taking amiodarone or class 1C agents for treatment of atrial fibrillation or atrial flutter. Am J Cardiol. 2004 May 1;93(9):1173-6. doi: 10.1016/j.amjcard.2004.01.051.
- Background Khan IA, Mehta NJ, Gowda RM. Amiodarone for pharmacological cardioversion of recent-onset atrial fibrillation. Int J Cardiol. 2003 Jun;89(2-3):239-48. doi: 10.1016/s0167-5273(02)00477-1.
- Background Hagens VE, Van Gelder IC, Crijns HJ; RAte Control Versus Electrical Cardioversion Of Persistent Atrial Fibrillation (RACE) Study Group. The RACE study in perspective of randomized studies on management of persistent atrial fibrillation. Card Electrophysiol Rev. 2003 Jun;7(2):118-21. doi: 10.1023/a:1027439430017.
- Background McNamara RL, Tamariz LJ, Segal JB, Bass EB. Management of atrial fibrillation: review of the evidence for the role of pharmacologic therapy, electrical cardioversion, and echocardiography. Ann Intern Med. 2003 Dec 16;139(12):1018-33. doi: 10.7326/0003-4819-139-12-200312160-00012.
- Background Maisel WH, Kuntz KM, Reimold SC, Lee TH, Antman EM, Friedman PL, Stevenson WG. Risk of initiating antiarrhythmic drug therapy for atrial fibrillation in patients admitted to a university hospital. Ann Intern Med. 1997 Aug 15;127(4):281-4. doi: 10.7326/0003-4819-127-4-199708150-00004.
- Background Kreiss Y, Sidi Y, Gur H. Efficacy and safety of intravenous amiodarone in recent-onset atrial fibrillation: experience in patients admitted to a general internal medicine department. Postgrad Med J. 1999 May;75(883):278-81. doi: 10.1136/pgmj.75.883.278.
- Background Xanthos T, Bassiakou E, Vlachos IS, Bassiakos S, Michalakis K, Moutzouris DA, Papadimitriou L. Intravenous and oral administration of amiodarone for the treatment of recent onset atrial fibrillation after digoxin administration. Int J Cardiol. 2007 Oct 18;121(3):291-5. doi: 10.1016/j.ijcard.2007.02.024. Epub 2007 Apr 16.
- Background Vardas PE, Kochiadakis GE, Igoumenidis NE, Tsatsakis AM, Simantirakis EN, Chlouverakis GI. Amiodarone as a first-choice drug for restoring sinus rhythm in patients with atrial fibrillation: a randomized, controlled study. Chest. 2000 Jun;117(6):1538-45. doi: 10.1378/chest.117.6.1538.
- Background Hohnloser SH, Kuck KH, Lilienthal J. Rhythm or rate control in atrial fibrillation--Pharmacological Intervention in Atrial Fibrillation (PIAF): a randomised trial. Lancet. 2000 Nov 25;356(9244):1789-94. doi: 10.1016/s0140-6736(00)03230-x.
- Background Bernard EO, Schmid ER, Schmidlin D, Scharf C, Candinas R, Germann R. Ibutilide versus amiodarone in atrial fibrillation: a double-blinded, randomized study. Crit Care Med. 2003 Apr;31(4):1031-4. doi: 10.1097/01.CCM.0000053555.78624.0F.
- Background Thomas SP, Guy D, Wallace E, Crampton R, Kijvanit P, Eipper V, Ross DL, Cooper MJ. Rapid loading of sotalol or amiodarone for management of recent onset symptomatic atrial fibrillation: a randomized, digoxin-controlled trial. Am Heart J. 2004 Jan;147(1):E3. doi: 10.1016/s0002-8703(03)00526-x.
- Background Decker WW, Smars PA, Vaidyanathan L, Goyal DG, Boie ET, Stead LG, Packer DL, Meloy TD, Boggust AJ, Haro LH, Laudon DA, Lobl JK, Sadosty AT, Schears RM, Schiebel NE, Hodge DO, Shen WK. A prospective, randomized trial of an emergency department observation unit for acute onset atrial fibrillation. Ann Emerg Med. 2008 Oct;52(4):322-8. doi: 10.1016/j.annemergmed.2007.12.015. Epub 2008 Mar 14.
- Background del Arco C, Martin A, Laguna P, Gargantilla P; Investigators in the Spanish Atrial Fibrillation in Emergency Medicine Study Group (GEFAUR). Analysis of current management of atrial fibrillation in the acute setting: GEFAUR-1 study. Ann Emerg Med. 2005 Nov;46(5):424-30. doi: 10.1016/j.annemergmed.2005.03.002. Epub 2005 May 31.
- Background Carlsson J, Miketic S, Windeler J, Cuneo A, Haun S, Micus S, Walter S, Tebbe U; STAF Investigators. Randomized trial of rate-control versus rhythm-control in persistent atrial fibrillation: the Strategies of Treatment of Atrial Fibrillation (STAF) study. J Am Coll Cardiol. 2003 May 21;41(10):1690-6. doi: 10.1016/s0735-1097(03)00332-2.
- Background Roy D, Talajic M, Nattel S, Wyse DG, Dorian P, Lee KL, Bourassa MG, Arnold JM, Buxton AE, Camm AJ, Connolly SJ, Dubuc M, Ducharme A, Guerra PG, Hohnloser SH, Lambert J, Le Heuzey JY, O'Hara G, Pedersen OD, Rouleau JL, Singh BN, Stevenson LW, Stevenson WG, Thibault B, Waldo AL; Atrial Fibrillation and Congestive Heart Failure Investigators. Rhythm control versus rate control for atrial fibrillation and heart failure. N Engl J Med. 2008 Jun 19;358(25):2667-77. doi: 10.1056/NEJMoa0708789.
- Background Galve E, Rius T, Ballester R, Artaza MA, Arnau JM, Garcia-Dorado D, Soler-Soler J. Intravenous amiodarone in treatment of recent-onset atrial fibrillation: results of a randomized, controlled study. J Am Coll Cardiol. 1996 Apr;27(5):1079-82. doi: 10.1016/0735-1097(95)00595-1.
- Background Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke. 1991 Aug;22(8):983-8. doi: 10.1161/01.str.22.8.983.
- Background Martinez-Marcos FJ, Garcia-Garmendia JL, Ortega-Carpio A, Fernandez-Gomez JM, Santos JM, Camacho C. Comparison of intravenous flecainide, propafenone, and amiodarone for conversion of acute atrial fibrillation to sinus rhythm. Am J Cardiol. 2000 Nov 1;86(9):950-3. doi: 10.1016/s0002-9149(00)01128-0.
- Background Kochiadakis GE, Igoumenidis NE, Hamilos ME, Marketou ME, Chlouverakis GI, Vardas PE. A comparative study of the efficacy and safety of procainamide versus propafenone versus amiodarone for the conversion of recent-onset atrial fibrillation. Am J Cardiol. 2007 Jun 15;99(12):1721-5. doi: 10.1016/j.amjcard.2007.01.059. Epub 2007 Apr 26.
- Background Cybulski J, Kulakowski P, Budaj A, Danielewicz H, Maciejewicz J, Kawka-Urbanek T, Ceremuzynski L. Intravenous amiodarone for cardioversion of recent-onset atrial fibrillation. Clin Cardiol. 2003 Jul;26(7):329-35. doi: 10.1002/clc.4950260707.
- Background Hilleman DE, Spinler SA. Conversion of recent-onset atrial fibrillation with intravenous amiodarone: a meta-analysis of randomized controlled trials. Pharmacotherapy. 2002 Jan;22(1):66-74. doi: 10.1592/phco.22.1.66.33492.
- Background National Clinical Guideline Centre (UK). Atrial Fibrillation: The Management of Atrial Fibrillation. London: National Institute for Health and Care Excellence (UK); 2014 Jun. Available from http://www.ncbi.nlm.nih.gov/books/NBK248059/
- Background January CT, Wann LS, Alpert JS, Calkins H, Cigarroa JE, Cleveland JC Jr, Conti JB, Ellinor PT, Ezekowitz MD, Field ME, Murray KT, Sacco RL, Stevenson WG, Tchou PJ, Tracy CM, Yancy CW; ACC/AHA Task Force Members. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines and the Heart Rhythm Society. Circulation. 2014 Dec 2;130(23):e199-267. doi: 10.1161/CIR.0000000000000041. Epub 2014 Mar 28. No abstract available.
- Background Freemantle N, Lafuente-Lafuente C, Mitchell S, Eckert L, Reynolds M. Mixed treatment comparison of dronedarone, amiodarone, sotalol, flecainide, and propafenone, for the management of atrial fibrillation. Europace. 2011 Mar;13(3):329-45. doi: 10.1093/europace/euq450. Epub 2011 Jan 11.
- Background Nadarasa K, Williams MJ. Single high oral dose amiodarone for cardioversion of recent onset atrial fibrillation. Heart Lung Circ. 2012 Aug;21(8):444-8. doi: 10.1016/j.hlc.2012.03.015. Epub 2012 May 2.
- Background Patel DA, Lavie CJ, Milani RV, Shah S, Gilliland Y. Clinical implications of left atrial enlargement: a review. Ochsner J. 2009 Winter;9(4):191-6.
- Background Danias PG, Caulfield TA, Weigner MJ, Silverman DI, Manning WJ. Likelihood of spontaneous conversion of atrial fibrillation to sinus rhythm. J Am Coll Cardiol. 1998 Mar 1;31(3):588-92. doi: 10.1016/s0735-1097(97)00534-2.
- Background Emren SV, Kocabas U, Duygu H, Levent F, Simsek EC, Yapan Emren Z, Tuluce S. The role of HATCH score in predicting the success rate of sinus rhythm following electrical cardioversion of atrial fibrillation. Kardiol Pol. 2016;74(9):978-84. doi: 10.5603/KP.a2016.0044. Epub 2016 Apr 4.
- Background Suenari K, Chao TF, Liu CJ, Kihara Y, Chen TJ, Chen SA. Usefulness of HATCH score in the prediction of new-onset atrial fibrillation for Asians. Medicine (Baltimore). 2017 Jan;96(1):e5597. doi: 10.1097/MD.0000000000005597.
- Background Fuster V, Ryden LE, Cannom DS, Crijns HJ, Curtis AB, Ellenbogen KA, Halperin JL, Le Heuzey JY, Kay GN, Lowe JE, Olsson SB, Prystowsky EN, Tamargo JL, Wann S, Smith SC Jr, Jacobs AK, Adams CD, Anderson JL, Antman EM, Halperin JL, Hunt SA, Nishimura R, Ornato JP, Page RL, Riegel B, Priori SG, Blanc JJ, Budaj A, Camm AJ, Dean V, Deckers JW, Despres C, Dickstein K, Lekakis J, McGregor K, Metra M, Morais J, Osterspey A, Tamargo JL, Zamorano JL; American College of Cardiology; American Heart Association Task Force; European Society of Cardiology Committee for Practice Guidelines; European Heart Rhythm Association; Heart Rhythm Society. ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation: full text: a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Revise the 2001 guidelines for the management of patients with atrial fibrillation) developed in collaboration with the European Heart Rhythm Association and the Heart Rhythm Society. Europace. 2006 Sep;8(9):651-745. doi: 10.1093/europace/eul097. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amiodarone | Small molecule | 20 mg/kg | Intravenous |