SOAR: Study Observing Antiarrhythmic Remodelling Using LGE-MRI

NCT01182376 | Completed Phase 3 Results DMC

• 1 other identifier: IRB_00040931
• Study Type: interventional
• Target: 33
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of this study is to demonstrate how dronedarone (Multaq®) may aid in the slowing of progression of left atrial and ventricular fibrosis in patients with atrial fibrillation as assessed by late gadolinium enhanced magnetic resonance imaging.

Conditions

Atrial Fibrillation

Keywords

Multaq; dronedarone; Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• LA Fibrosis

  The change in left atrial fibrosis percentage, as measured on a scale, using MRI imaging, from baseline to the end of treatment.

  baseline, 1 year

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Half of the patients will be assigned placebo.

Drug: Placebo

Multaq® (dronedarone)

EXPERIMENTAL

Half of the patients will be prescribed dronedarone.

Drug: dronedarone

Interventions

dronedarone DRUG

Dronedarone will be prescribed by the patient's team according to established guidelines.

Also known as: Multaq®

Multaq® (dronedarone)

Placebo DRUG

Placebo will be administered by the patient's team according to established guidelines.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients age 18 and older
• Must carry a diagnosis of Paroxysmal Atrial Fibrillation for 1 months or longer prior to being enrolled.
• AAD: Multaq® (dronedarone) candidate
• Patients have given informed consent

You may not qualify if:

• Patients who are unavailable to continue follow-up at the University of Utah outpatient clinic.
• Patients weighing \>200 lbs (MR image efficacy decreases due to density)
• Prior RF Ablation treatment for atrial fibrillation
• Severe renal failure manifested by a chronic GFR of \< 30 mL/min, or acute renal failure regardless of the GFR, until the renal function has stabilized. (Gadolinium contraindication)
• Enrollment in any other investigational trial for anti-arrhythmic therapy
• Any health related Gadolinium/MRI contraindications: Pacemaker devices, etc.
• Pregnant women
• Individuals with cognitive impairments who are unable to give informed consent
• Multaq® (dronedarone) contraindications:
• NYHA Class IV heart failure or NYHA Class II - III heart failure with a recent decompensation requiring hospitalization or referral to a specialized heart failure clinic
• Second- or third-degree atrioventricular (AV) block or sick sinus syndrome
• Bradycardia \< 50 bpm
• Concomitant use of strong CYP 3A inhibitors, such as ketoconazole, itraconazole, voriconazole, cyclosporine, telithromycin, clarithromycin, nefazodone, and ritonavir
• Concomitant use of drugs or herbal products that prolong the QT interval and might increase the risk of Torsade de Pointes, such as phenothiazine anti-psychotics, tricyclic antidepressants, certain oral macrolide antibiotics, and Class I and III antiarrhythmics
• QTc Bazett interval ≥ 500 ms or PR interval \> 280 ms

Sponsors & Collaborators

• University of Utah: lead
• Sanofi: collaborator

Related Publications (15)

• Swynghedauw B. Molecular mechanisms of myocardial remodeling. Physiol Rev. 1999 Jan;79(1):215-62. doi: 10.1152/physrev.1999.79.1.215.

  PMID: 9922372 BACKGROUND

• Oral H, Pappone C, Chugh A, Good E, Bogun F, Pelosi F Jr, Bates ER, Lehmann MH, Vicedomini G, Augello G, Agricola E, Sala S, Santinelli V, Morady F. Circumferential pulmonary-vein ablation for chronic atrial fibrillation. N Engl J Med. 2006 Mar 2;354(9):934-41. doi: 10.1056/NEJMoa050955.

  PMID: 16510747 BACKGROUND

• Lee SH, Tai CT, Hsieh MH, Tsai CF, Lin YK, Tsao HM, Yu WC, Huang JL, Ueng KC, Cheng JJ, Ding YA, Chen SA. Predictors of early and late recurrence of atrial fibrillation after catheter ablation of paroxysmal atrial fibrillation. J Interv Card Electrophysiol. 2004 Jun;10(3):221-6. doi: 10.1023/B:JICE.0000026915.02503.92.

  PMID: 15133358 BACKGROUND

• Oral H, Knight BP, Ozaydin M, Tada H, Chugh A, Hassan S, Scharf C, Lai SW, Greenstein R, Pelosi F Jr, Strickberger SA, Morady F. Clinical significance of early recurrences of atrial fibrillation after pulmonary vein isolation. J Am Coll Cardiol. 2002 Jul 3;40(1):100-4. doi: 10.1016/s0735-1097(02)01939-3.

  PMID: 12103262 BACKGROUND

• O'Donnell D, Furniss SS, Dunuwille A, Bourke JP. Delayed cure despite early recurrence after pulmonary vein isolation for atrial fibrillation. Am J Cardiol. 2003 Jan 1;91(1):83-5. doi: 10.1016/s0002-9149(02)03005-9. No abstract available.

  PMID: 12505579 BACKGROUND

• Vasamreddy CR, Lickfett L, Jayam VK, Nasir K, Bradley DJ, Eldadah Z, Dickfeld T, Berger R, Calkins H. Predictors of recurrence following catheter ablation of atrial fibrillation using an irrigated-tip ablation catheter. J Cardiovasc Electrophysiol. 2004 Jun;15(6):692-7. doi: 10.1046/j.1540-8167.2004.03538.x.

  PMID: 15175066 BACKGROUND

• Lo LW, Tai CT, Lin YJ, Chang SL, Wongcharoen W, Hsieh MH, Tuan TC, Udyavar AR, Hu YF, Chen YJ, Tsao HM, Chen SA. Mechanisms of recurrent atrial fibrillation: comparisons between segmental ostial versus circumferential pulmonary vein isolation. J Cardiovasc Electrophysiol. 2007 Aug;18(8):803-7. doi: 10.1111/j.1540-8167.2007.00848.x. Epub 2007 May 14.

  PMID: 17504254 BACKGROUND

• Pappone C, Oreto G, Rosanio S, Vicedomini G, Tocchi M, Gugliotta F, Salvati A, Dicandia C, Calabro MP, Mazzone P, Ficarra E, Di Gioia C, Gulletta S, Nardi S, Santinelli V, Benussi S, Alfieri O. Atrial electroanatomic remodeling after circumferential radiofrequency pulmonary vein ablation: efficacy of an anatomic approach in a large cohort of patients with atrial fibrillation. Circulation. 2001 Nov 20;104(21):2539-44. doi: 10.1161/hc4601.098517.

  PMID: 11714647 BACKGROUND

• Riley MJ, Marrouche NF. Ablation of atrial fibrillation. Curr Probl Cardiol. 2006 May;31(5):361-90. doi: 10.1016/j.cpcardiol.2006.01.002.

  PMID: 16690376 BACKGROUND

• Wazni OM, Marrouche NF, Martin DO, Verma A, Bhargava M, Saliba W, Bash D, Schweikert R, Brachmann J, Gunther J, Gutleben K, Pisano E, Potenza D, Fanelli R, Raviele A, Themistoclakis S, Rossillo A, Bonso A, Natale A. Radiofrequency ablation vs antiarrhythmic drugs as first-line treatment of symptomatic atrial fibrillation: a randomized trial. JAMA. 2005 Jun 1;293(21):2634-40. doi: 10.1001/jama.293.21.2634.

  PMID: 15928285 BACKGROUND

• Oakes RS, Badger TJ, Kholmovski EG, Akoum N, Burgon NS, Fish EN, Blauer JJ, Rao SN, DiBella EV, Segerson NM, Daccarett M, Windfelder J, McGann CJ, Parker D, MacLeod RS, Marrouche NF. Detection and quantification of left atrial structural remodeling with delayed-enhancement magnetic resonance imaging in patients with atrial fibrillation. Circulation. 2009 Apr 7;119(13):1758-67. doi: 10.1161/CIRCULATIONAHA.108.811877. Epub 2009 Mar 23.

  PMID: 19307477 BACKGROUND

• Badger TJ, Oakes RS, Daccarett M, Burgon NS, Akoum N, Fish EN, Blauer JJ, Rao SN, Adjei-Poku Y, Kholmovski EG, Vijayakumar S, Di Bella EV, MacLeod RS, Marrouche NF. Temporal left atrial lesion formation after ablation of atrial fibrillation. Heart Rhythm. 2009 Feb;6(2):161-8. doi: 10.1016/j.hrthm.2008.10.042. Epub 2008 Nov 6.

  PMID: 19187904 BACKGROUND

• Sinha AM, Schmidt M, Marschang H, Gutleben K, Ritscher G, Brachmann J, Marrouche NF. Role of left ventricular scar and Purkinje-like potentials during mapping and ablation of ventricular fibrillation in dilated cardiomyopathy. Pacing Clin Electrophysiol. 2009 Mar;32(3):286-90. doi: 10.1111/j.1540-8159.2008.02233.x.

  PMID: 19272055 BACKGROUND

• Badger TJ, Adjei-Poku YA, Marrouche NF. MRI in cardiac electrophysiology: the emerging role of delayed-enhancement MRI in atrial fibrillation ablation. Future Cardiol. 2009 Jan;5(1):63-70. doi: 10.2217/14796678.5.1.63.

  PMID: 19371204 BACKGROUND

• Weber KT, Weglicki WB, Simpson RU. Macro- and micronutrient dyshomeostasis in the adverse structural remodelling of myocardium. Cardiovasc Res. 2009 Feb 15;81(3):500-8. doi: 10.1093/cvr/cvn261. Epub 2008 Oct 3.

  PMID: 18835843 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Dronedarone

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amiodarone; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Clinical Research Manager
• Organization: University of Utah

christina.pacchia@hsc.utah.edu

8015873889

Study Officials

• Nassir F Marrouche, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of cardiology

Study Record Dates

• First Submitted: August 11, 2010
• First Posted: August 16, 2010
• Study Start: November 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 19, 2016
• Results First Posted: February 19, 2016

Record last verified: 2016-01