Renal sympathetic denervation versus antiarrhythmic drugs for drug-resistant hypertension and symptomatic atrial fibrillation (RSDforAF) trial: study protocol for a randomized controlled trial

Trials

Qijun Shan¹  Yuehui Yin²  Min Qiu¹ 

[1] Cardiovascular Department, The First Affiliated Hospital of Nanjing Medical University, No 300, Guangzhou Road, Nanjing, Jiangsu 210029, China;Cardiovascular Department, The Second Affiliated Hospital of Chongqing Medical University, No 76, Linjiang Road, Chongqing, China

关键词: Clinical trial;    Sympathetic nerve;    Atrial fibrillation;    Hypertension;    Renal sympathetic denervation;   

Others  :  1093752
DOI  :  10.1186/1745-6215-14-168

 received in 2013-02-18, accepted in 2013-05-28,  发布年份 2013

【 摘 要 】

Background

Recently, catheter-based renal sympathetic denervation (RSD) has been verified to be safely used to substantially reduce the levels of blood pressure, left ventricular hypertrophy, sleep apnea severity and norepinephrine spillover, and improve glucose tolerance. All these pathological changes are recognized as independent risk factors for the development and recurrence of atrial fibrillation (AF). A randomized, single-blind, parallel-control, multicenter clinical trial is being conducted to compare RSD with antiarrhythmic drugs (AAD) in patients with drug-resistant hypertension and symptomatic AF (RSDforAF trial).

Methods/design

Patients with drug-resistant hypertension and symptomatic AF will be randomized to RSD and the drug treatment groups. Patients will be followed for 12 months until study closure. Up to 200 patients may be enrolled in six medical centers in China. The primary objective is to study the effects of RSD on AF burden and blood pressure in patients with hypertension and symptomatic AF.

Discussion

RSDforAF trial will test the hypothesis that RSD is superior to AAD in reducing AF burden and blood pressure in patients with drug-resistant hypertension and symptomatic AF.

Trial registration

ClinicalTrials.gov, NCT01713270

【 授权许可】

   
2013 Qiu et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

【 参考文献 】

• [1]Fuster V, Ryden LE, Cannom DS, Crijns HJ, Curtis AB, Ellenbogen KA, Halperin JL, Kay GN, Le Huezey JY, Lowe JE, Olsson SB, Prystowsky EN, Tamargo JL, Wann LS, Smith SJ, Priori SG, Estes NR, Ezekowitz MD, Jackman WM, January CT, Lowe JE, Page RL, Slotwiner DJ, Stevenson WG, Tracy CM, Jacobs AK, Anderson JL, Albert N, Buller CE, Creager MA, et al.: ACCF/AHA/HRS focused updates incorporated into the ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation: a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Circulation 2011, 2011(123):e269-e367.
• [2]Healey JS, Connolly SJ: Atrial fibrillation: hypertension as a causative agent, risk factor for complications, and potential therapeutic target. Am J Cardiol 2003, 91:9G-14G.
• [3]Krum H, Schlaich M, Whitbourn R, Sobotka PA, Sadowski J, Bartus K, Kapelak B, Walton A, Sievert H, Thambar S, Abraham WT, Esler M: Catheter-based renal sympathetic denervation for resistant hypertension: a multicentre safety and proof-of-principle cohort study. Lancet 2009, 373:1275-1281.
• [4]Witkowski A, Prejbisz A, Florczak E, Kadziela J, Sliwinski P, Bielen P, Michalowska I, Kabat M, Warchol E, Januszewicz M, Narkiewicz K, Somers VK, Sobotka PA, Januszewicz A: Effects of renal sympathetic denervation on blood pressure, sleep apnea course, and glycemic control in patients with resistant hypertension and sleep apnea. Hypertension 2011, 58:559-565.
• [5]Brandt MC, Mahfoud F, Reda S, Schirmer SH, Erdmann E, Bohm M, Hoppe UC: Renal sympathetic denervation reduces left ventricular hypertrophy and improves cardiac function in patients with resistant hypertension. J Am Coll Cardiol 2012, 59:901-909.
• [6]Schlaich MP, Sobotka PA, Krum H, Lambert E, Esler MD: Renal sympathetic-nerve ablation for uncontrolled hypertension. N Engl J Med 2009, 361:932-934.
• [7]Calkins H, Kuck KH, Cappato R, Brugada J, Camm AJ, Chen SA, Crijns HJ, Damiano RJ, Davies DW, DiMarco J, Edgerton J, Ellenbogen K, Ezekowitz MD, Haines DE, Haissaguerre M, Hindricks G, Iesaka Y, Jackman W, Jalife J, Jais P, Kalman J, Keane D, Kim YH, Kirchhof P, Klein G, Kottkamp H, Kumagai K, Lindsay BD, Mansour M, Marchlinski FE, et al.: 2012 HRS/EHRA/ECAS expert consensus statement on catheter and surgical ablation of atrial fibrillation: recommendations for patient selection, procedural techniques, patient management and follow-up, definitions, endpoints, and research trial design: a report of the Heart Rhythm Society (HRS) Task Force on Catheter and Surgical Ablation of Atrial Fibrillation. Developed in partnership with the European Heart Rhythm Association (EHRA), a registered branch of the European Society of Cardiology (ESC) and the European Cardiac Arrhythmia Society (ECAS); and in collaboration with the American College of Cardiology (ACC), American Heart Association (AHA), the Asia Pacific Heart Rhythm Society (APHRS), and the Society of Thoracic Surgeons (STS). Endorsed by the governing bodies of the American College of Cardiology Foundation, the American Heart Association, the European Cardiac Arrhythmia Society, the European Heart Rhythm Association, the Society of Thoracic Surgeons, the Asia Pacific Heart Rhythm Society, and the Heart Rhythm Society. Hear Rhythm 2012, 9:632-696.
• [8]Ahmed H, Neuzil P, Skoda J, Petru J, Sediva L, Schejbalova M, Reddy VY: Renal sympathetic denervation using an irrigated radiofrequency ablation catheter for the management of drug-resistant hypertension. JACC Cardiovasc Interv 2012, 5:758-765.
• [9]Pokushalov E, Romanov A, Corbucci G, Artyomenko S, Baranova V, Turov A, Shirokova N, Karaskov A, Mittal S, Steinberg JS: A randomized comparison of pulmonary vein isolation with versus without concomitant renal artery denervation in patients with refractory symptomatic atrial fibrillation and resistant hypertension. J Am Coll Cardiol 2012, 60:1163-1170.
• [10]Sorgente A, Tung P, Wylie J, Josephson ME: Six year follow-up after catheter ablation of atrial fibrillation: a palliation more than a true cure. Am J Cardiol 2012, 109:1179-1186.
• [11]Cosedis NJ, Johannessen A, Raatikainen P, Hindricks G, Walfridsson H, Kongstad O, Pehrson S, Englund A, Hartikainen J, Mortensen LS, Hansen PS: Radiofrequency ablation as initial therapy in paroxysmal atrial fibrillation. N Engl J Med 2012, 367:1587-1595.
• [12]Kannel WB, Wolf PA, Benjamin EJ, Levy D: Prevalence, incidence, prognosis, and predisposing conditions for atrial fibrillation: population-based estimates. Am J Cardiol 1998, 82:2N-9N.
• [13]Kalifa J, Jalife J, Zaitsev AV, Bagwe S, Warren M, Moreno J, Berenfeld O, Nattel S: Intra-atrial pressure increases rate and organization of waves emanating from the superior pulmonary veins during atrial fibrillation. Circulation 2003, 108:668-671.
• [14]Burstein B, Nattel S: Atrial fibrosis: mechanisms and clinical relevance in atrial fibrillation. J Am Coll Cardiol 2008, 51:802-809.
• [15]Lau DH, Mackenzie L, Kelly DJ, Psaltis PJ, Brooks AG, Worthington M, Rajendram A, Kelly DR, Zhang Y, Kuklik P, Nelson AJ, Wong CX, Worthley SG, Rao M, Faull RJ, Edwards J, Saint DA, Sanders P: Hypertension and atrial fibrillation: evidence of progressive atrial remodeling with electrostructural correlate in a conscious chronically instrumented ovine model. Hear Rhythm 2010, 7:1282-1290.
• [16]Patterson E, Lazzara R, Szabo B, Liu H, Tang D, Li YH, Scherlag BJ, Po SS: Sodium-calcium exchange initiated by the Ca2+ transient: an arrhythmia trigger within pulmonary veins. J Am Coll Cardiol 2006, 47:1196-1206.
• [17]Sharifov OF, Fedorov VV, Beloshapko GG, Glukhov AV, Yushmanova AV, Rosenshtraukh LV: Roles of adrenergic and cholinergic stimulation in spontaneous atrial fibrillation in dogs. J Am Coll Cardiol 2004, 43:483-490.
• [18]Oral H, Crawford T, Frederick M, Gadeela N, Wimmer A, Dey S, Sarrazin JF, Kuhne M, Chalfoun N, Wells D, Good E, Jongnarangsin K, Chugh A, Bogun F, Pelosi FJ, Morady F: Inducibility of paroxysmal atrial fibrillation by isoproterenol and its relation to the mode of onset of atrial fibrillation. J Cardiovasc Electrophysiol 2008, 19:466-470.
• [19]Kuhlkamp V, Schirdewan A, Stangl K, Homberg M, Ploch M, Beck OA: Use of metoprolol CR/XL to maintain sinus rhythm after conversion from persistent atrial fibrillation: a randomized, double-blind, placebo-controlled study. J Am Coll Cardiol 2000, 36:139-146.
• [20]Nergardh AK, Rosenqvist M, Nordlander R, Frick M: Maintenance of sinus rhythm with metoprolol CR initiated before cardioversion and repeated cardioversion of atrial fibrillation: a randomized double-blind placebo-controlled study. Eur Heart J 2007, 28:1351-1357.
• [21]Chang CM, Wu TJ, Zhou S, Doshi RN, Lee MH, Ohara T, Fishbein MC, Karagueuzian HS, Chen PS, Chen LS: Nerve sprouting and sympathetic hyperinnervation in a canine model of atrial fibrillation produced by prolonged right atrial pacing. Circulation 2001, 103:22-25.
• [22]Yi Z, Zhang HC, Zhang P, Liu G, Lu P, Sun JL, Liu B, Guo JH: The relationship of paroxysmal atrial fibrillation and regional sympathetic innervations in the atria and pulmonary veins: experiment with dogs. Zhonghua Yi Xue Za Zhi 2007, 87:3433-3435.
• [23]Shen MJ, Choi EK, Tan AY, Lin SF, Fishbein MC, Chen LS, Chen PS: Neural mechanisms of atrial arrhythmias. Nat Rev Cardiol 2012, 9:30-39.
• [24]Zhao Q, Yu S, Zou M, Dai Z, Wang X, Xiao J, Huang C: Effect of renal sympathetic denervation on the inducibility of atrial fibrillation during rapid atrial pacing. J Interv Card Electrophysiol 2012, 35:119-125.
• [25]Linz D, Mahfoud F, Schotten U, Ukena C, Neuberger HR, Wirth K, Bohm M: Renal sympathetic denervation suppresses postapneic blood pressure rises and atrial fibrillation in a model for sleep apnea. Hypertension 2012, 60:172-178.
• [26]Linz D, Mahfoud F, Schotten U, Ukena C, Hohl M, Neuberger HR, Wirth K, Bohm M: Renal sympathetic denervation provides ventricular rate control but does not prevent atrial electrical remodeling during atrial fibrillation. Hypertension 2013, 61(1):225-231.
• [27]Vollmann D, Sossalla S, Schroeter MR, Zabel M: Renal artery ablation instead of pulmonary vein ablation in a hypertensive patient with symptomatic, drug-resistant, persistent atrial fibrillation. Clin Res Cardiol 2012, 102(4):315-318.