Clinical trial NCT03227393: The Effect of Yoga on Cardiac Sympathetic Innervation Evaluated by I-123 mIBG
Official title: The Effect of Yoga on Cardiac Sympathetic Innervation Evaluated by I-123 mIBG
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Heart Failure, Systolic
Keywords: Heart Failure, Systolic
Defibrillators, Implantable
Pacemaker, Artificial
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
First posted: 2017-07-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate if yoga practice will reduce cardiac sympathetic activity and subsequently cardiac arrhythmias.

Detailed description: Subjects with reduced ejection fraction will be randomized to 8 weeks Yoga training (1 in class session and home practice) vs. no Yoga. They will undergo holter monitoring, cardiac device interrogation, and I-123 mIBG imaging at the beginning and end of the study.

Eligibility criteria: Inclusion Criteria:

* Negative pregnancy test in females
* Ejection Fraction \</= 40% assessed by echocardiogram within the last 12 months
* Stable dose of heart failure medications including afterload reducing medication such as ACE-I, ARB and hydralazine; beta blockers; digoxin and aldosterone antagonist for at least 4 months and no anticipated changes for 8 weeks. (i.e. no greater than a 50% dose change within the past month)
* Has an implantable pacemaker or ICD
* NYHA II-IV

Exclusion Criteria:

* pregnant or lactating female
* females without a pregnancy test
* co-administration of a positive inotrope (i.e. milrinone or dobutamine)
* history of significant medical non-compliance
* unwilling to adhere to the protocol
* Orthopedic limitation making yoga participation difficult
* Underlying cardiac rhythm other than sinus rhythm
* Recent history within 6 months prior to enrollment of unstable coronary artery disease (unstable angina, recent heart attack, recent revascularization, or decompensated heart failure)
* implantation of a cardiac resynchronization therapy device in the past 3 months.
* TIA, CVA, or major surgery in the past 3 months
* iodine or adreview (123-MIBG) allergy

Primary outcomes:
measure: Cardiac sympathetic activity following yoga training
timeFrame: 8 weeks
Secondary outcomes:
measure: Relationship between I-123MIBG heart-to-mediastinal ratios and the total atrial and ventricular arrhythmia burden.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Mehran Attari
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roger VL, Go AS, Lloyd-Jones DM, Benjamin EJ, Berry JD, Borden WB, Bravata DM, Dai S, Ford ES, Fox CS, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Makuc DM, Marcus GM, Marelli A, Matchar DB, Moy CS, Mozaffarian D, Mussolino ME, Nichol G, Paynter NP, Soliman EZ, Sorlie PD, Sotoodehnia N, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2012 update: a report from the American Heart Association. Circulation. 2012 Jan 3;125(1):e2-e220. doi: 10.1161/CIR.0b013e31823ac046. Epub 2011 Dec 15. No abstract available.
citation: Thrall G, Lip GY, Carroll D, Lane D. Depression, anxiety, and quality of life in patients with atrial fibrillation. Chest. 2007 Oct;132(4):1259-64. doi: 10.1378/chest.07-0036. Epub 2007 Jul 23.
citation: 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. 2011 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 developed in partnership with the European Society of Cardiology and in collaboration with the European Heart Rhythm Association and the Heart Rhythm Society. J Am Coll Cardiol. 2011 Mar 15;57(11):e101-98. doi: 10.1016/j.jacc.2010.09.013. No abstract available.
citation: Cheriyath P, He F, Peters I, Li X, Alagona P Jr, Wu C, Pu M, Cascio WE, Liao D. Relation of atrial and/or ventricular premature complexes on a two-minute rhythm strip to the risk of sudden cardiac death (the Atherosclerosis Risk in Communities [ARIC] study). Am J Cardiol. 2011 Jan 15;107(2):151-5. doi: 10.1016/j.amjcard.2010.09.002.
citation: Florea VG, Cohn JN. The autonomic nervous system and heart failure. Circ Res. 2014 May 23;114(11):1815-26. doi: 10.1161/CIRCRESAHA.114.302589.
citation: La Rovere MT, Pinna GD, Hohnloser SH, Marcus FI, Mortara A, Nohara R, Bigger JT Jr, Camm AJ, Schwartz PJ; ATRAMI Investigators. Autonomic Tone and Reflexes After Myocardial Infarcton. Baroreflex sensitivity and heart rate variability in the identification of patients at risk for life-threatening arrhythmias: implications for clinical trials. Circulation. 2001 Apr 24;103(16):2072-7. doi: 10.1161/01.cir.103.16.2072.
citation: La Rovere MT, Pinna GD, Maestri R, Mortara A, Capomolla S, Febo O, Ferrari R, Franchini M, Gnemmi M, Opasich C, Riccardi PG, Traversi E, Cobelli F. Short-term heart rate variability strongly predicts sudden cardiac death in chronic heart failure patients. Circulation. 2003 Feb 4;107(4):565-70. doi: 10.1161/01.cir.0000047275.25795.17.
citation: Mitrani RD, Klein LS, Miles WM, Hackett FK, Burt RW, Wellman HN, Zipes DP. Regional cardiac sympathetic denervation in patients with ventricular tachycardia in the absence of coronary artery disease. J Am Coll Cardiol. 1993 Nov 1;22(5):1344-53. doi: 10.1016/0735-1097(93)90541-8.
citation: Paul M, Schafers M, Kies P, Acil T, Schafers K, Breithardt G, Schober O, Wichter T. Impact of sympathetic innervation on recurrent life-threatening arrhythmias in the follow-up of patients with idiopathic ventricular fibrillation. Eur J Nucl Med Mol Imaging. 2006 Aug;33(8):866-70. doi: 10.1007/s00259-005-0061-7. Epub 2006 Apr 13.
citation: Patterson E, Po SS, Scherlag BJ, Lazzara R. Triggered firing in pulmonary veins initiated by in vitro autonomic nerve stimulation. Heart Rhythm. 2005 Jun;2(6):624-31. doi: 10.1016/j.hrthm.2005.02.012.
citation: Coccagna G, Capucci A, Bauleo S, Boriani G, Santarelli A. Paroxysmal atrial fibrillation in sleep. Sleep. 1997 Jun;20(6):396-8. doi: 10.1093/sleep/20.6.396.
citation: Po SS, Yu L, Scherlag BJ. Cardiac autonomic nervous system: a tug of war between the big brain and little brain--friends or foes? Heart Rhythm. 2009 Dec;6(12):1780-1. doi: 10.1016/j.hrthm.2009.09.006. Epub 2009 Sep 6. No abstract available.
citation: Shen MJ, Shinohara T, Park HW, Frick K, Ice DS, Choi EK, Han S, Maruyama M, Sharma R, Shen C, Fishbein MC, Chen LS, Lopshire JC, Zipes DP, Lin SF, Chen PS. Continuous low-level vagus nerve stimulation reduces stellate ganglion nerve activity and paroxysmal atrial tachyarrhythmias in ambulatory canines. Circulation. 2011 May 24;123(20):2204-12. doi: 10.1161/CIRCULATIONAHA.111.018028. Epub 2011 May 9.
citation: Collura CA, Johnson JN, Moir C, Ackerman MJ. Left cardiac sympathetic denervation for the treatment of long QT syndrome and catecholaminergic polymorphic ventricular tachycardia using video-assisted thoracic surgery. Heart Rhythm. 2009 Jun;6(6):752-9. doi: 10.1016/j.hrthm.2009.03.024. Epub 2009 Mar 19.
citation: Schwartz PJ, Priori SG, Cerrone M, Spazzolini C, Odero A, Napolitano C, Bloise R, De Ferrari GM, Klersy C, Moss AJ, Zareba W, Robinson JL, Hall WJ, Brink PA, Toivonen L, Epstein AE, Li C, Hu D. Left cardiac sympathetic denervation in the management of high-risk patients affected by the long-QT syndrome. Circulation. 2004 Apr 20;109(15):1826-33. doi: 10.1161/01.CIR.0000125523.14403.1E. Epub 2004 Mar 29.
citation: Wilde AA, Bhuiyan ZA, Crotti L, Facchini M, De Ferrari GM, Paul T, Ferrandi C, Koolbergen DR, Odero A, Schwartz PJ. Left cardiac sympathetic denervation for catecholaminergic polymorphic ventricular tachycardia. N Engl J Med. 2008 May 8;358(19):2024-9. doi: 10.1056/NEJMoa0708006.
citation: Bourke T, Vaseghi M, Michowitz Y, Sankhla V, Shah M, Swapna N, Boyle NG, Mahajan A, Narasimhan C, Lokhandwala Y, Shivkumar K. Neuraxial modulation for refractory ventricular arrhythmias: value of thoracic epidural anesthesia and surgical left cardiac sympathetic denervation. Circulation. 2010 Jun 1;121(21):2255-62. doi: 10.1161/CIRCULATIONAHA.109.929703. Epub 2010 May 17.
citation: Thayer JF, Lane RD. The role of vagal function in the risk for cardiovascular disease and mortality. Biol Psychol. 2007 Feb;74(2):224-42. doi: 10.1016/j.biopsycho.2005.11.013. Epub 2006 Dec 19.
citation: Desai MY, Watanabe MA, Laddu AA, Hauptman PJ. Pharmacologic modulation of parasympathetic activity in heart failure. Heart Fail Rev. 2011 Mar;16(2):179-93. doi: 10.1007/s10741-010-9195-1.
citation: Pullen PR, Nagamia SH, Mehta PK, Thompson WR, Benardot D, Hammoud R, Parrott JM, Sola S, Khan BV. Effects of yoga on inflammation and exercise capacity in patients with chronic heart failure. J Card Fail. 2008 Jun;14(5):407-13. doi: 10.1016/j.cardfail.2007.12.007. Epub 2008 May 27.
citation: Cramer H, Lauche R, Haller H, Dobos G, Michalsen A. A systematic review of yoga for heart disease. Eur J Prev Cardiol. 2015 Mar;22(3):284-95. doi: 10.1177/2047487314523132. Epub 2014 Feb 3.
citation: Krishna BH, Pal P, G K P, J B, E J, Y S, M G S, G S G. Effect of yoga therapy on heart rate, blood pressure and cardiac autonomic function in heart failure. J Clin Diagn Res. 2014 Jan;8(1):14-6. doi: 10.7860/JCDR/2014/7844.3983. Epub 2014 Jan 12.
citation: Krishna BH, Pal P, Pal G, Balachander J, Jayasettiaseelon E, Sreekanth Y, Sridhar M, Gaur G. A Randomized Controlled Trial to Study the Effect of Yoga Therapy on Cardiac Function and N Terminal Pro BNP in Heart Failure. Integr Med Insights. 2014 Apr 1;9:1-6. doi: 10.4137/IMI.S13939. eCollection 2014.
citation: Pullen PR, Thompson WR, Benardot D, Brandon LJ, Mehta PK, Rifai L, Vadnais DS, Parrott JM, Khan BV. Benefits of yoga for African American heart failure patients. Med Sci Sports Exerc. 2010 Apr;42(4):651-7. doi: 10.1249/MSS.0b013e3181bf24c4.
citation: Howie-Esquivel J, Lee J, Collier G, Mehling W, Fleischmann K. Yoga in heart failure patients: a pilot study. J Card Fail. 2010 Sep;16(9):742-9. doi: 10.1016/j.cardfail.2010.04.011. Epub 2010 Jun 8.
citation: Vempati RP, Telles S. Yoga-based guided relaxation reduces sympathetic activity judged from baseline levels. Psychol Rep. 2002 Apr;90(2):487-94. doi: 10.2466/pr0.2002.90.2.487.
citation: Khattab K, Khattab AA, Ortak J, Richardt G, Bonnemeier H. Iyengar yoga increases cardiac parasympathetic nervous modulation among healthy yoga practitioners. Evid Based Complement Alternat Med. 2007 Dec;4(4):511-7. doi: 10.1093/ecam/nem087.
citation: Santaella DF, Devesa CR, Rojo MR, Amato MB, Drager LF, Casali KR, Montano N, Lorenzi-Filho G. Yoga respiratory training improves respiratory function and cardiac sympathovagal balance in elderly subjects: a randomised controlled trial. BMJ Open. 2011 May 24;1(1):e000085. doi: 10.1136/bmjopen-2011-000085.
citation: Lakkireddy D, Atkins D, Pillarisetti J, Ryschon K, Bommana S, Drisko J, Vanga S, Dawn B. Effect of yoga on arrhythmia burden, anxiety, depression, and quality of life in paroxysmal atrial fibrillation: the YOGA My Heart Study. J Am Coll Cardiol. 2013 Mar 19;61(11):1177-82. doi: 10.1016/j.jacc.2012.11.060. Epub 2013 Jan 30.
citation: Kiecolt-Glaser JK, Christian LM, Andridge R, Hwang BS, Malarkey WB, Belury MA, Emery CF, Glaser R. Adiponectin, leptin, and yoga practice. Physiol Behav. 2012 Dec 5;107(5):809-13. doi: 10.1016/j.physbeh.2012.01.016. Epub 2012 Jan 27.
citation: Toise SC, Sears SF, Schoenfeld MH, Blitzer ML, Marieb MA, Drury JH, Slade MD, Donohue TJ. Psychosocial and cardiac outcomes of yoga for ICD patients: a randomized clinical control trial. Pacing Clin Electrophysiol. 2014 Jan;37(1):48-62. doi: 10.1111/pace.12252. Epub 2013 Aug 26.
citation: Jacobson AF, Lombard J, Banerjee G, Camici PG. 123I-mIBG scintigraphy to predict risk for adverse cardiac outcomes in heart failure patients: design of two prospective multicenter international trials. J Nucl Cardiol. 2009 Jan-Feb;16(1):113-21. doi: 10.1007/s12350-008-9008-2. Epub 2009 Jan 20.
citation: Jacobson AF, Senior R, Cerqueira MD, Wong ND, Thomas GS, Lopez VA, Agostini D, Weiland F, Chandna H, Narula J; ADMIRE-HF Investigators. Myocardial iodine-123 meta-iodobenzylguanidine imaging and cardiac events in heart failure. Results of the prospective ADMIRE-HF (AdreView Myocardial Imaging for Risk Evaluation in Heart Failure) study. J Am Coll Cardiol. 2010 May 18;55(20):2212-21. doi: 10.1016/j.jacc.2010.01.014. Epub 2010 Feb 25.
citation: Narula J, Gerson M, Thomas GS, Cerqueira MD, Jacobson AF. (1)(2)(3)I-MIBG Imaging for Prediction of Mortality and Potentially Fatal Events in Heart Failure: The ADMIRE-HFX Study. J Nucl Med. 2015 Jul;56(7):1011-8. doi: 10.2967/jnumed.115.156406. Epub 2015 Jun 11.
citation: Verschure DO, Veltman CE, Manrique A, Somsen GA, Koutelou M, Katsikis A, Agostini D, Gerson MC, van Eck-Smit BL, Scholte AJ, Jacobson AF, Verberne HJ. For what endpoint does myocardial 123I-MIBG scintigraphy have the greatest prognostic value in patients with chronic heart failure? Results of a pooled individual patient data meta-analysis. Eur Heart J Cardiovasc Imaging. 2014 Sep;15(9):996-1003. doi: 10.1093/ehjci/jeu044. Epub 2014 Mar 30.
citation: Gerson MC, McGuire N, Wagoner LE. Sympathetic nervous system function as measured by I-123 metaiodobenzylguanidine predicts transplant-free survival in heart failure patients with idiopathic dilated cardiomyopathy. J Card Fail. 2003 Oct;9(5):384-91. doi: 10.1054/s1071-9164(03)00134-9.
citation: Waqar F, Dunlap SH, Gerson MC. What will be the role of I-123 MIBG in improving the outcome of medically treated heart failure patients? J Nucl Cardiol. 2012 Dec;19(6):1198-205; quiz 1206-10. doi: 10.1007/s12350-012-9612-z. No abstract available.
citation: Gerson MC, Dwivedi AK, Abdallah M, Shukla R, Jacobson AF. Significance of I-123 metaiodobenzylguanidine ((1)(2)(3)I-MIBG) lung activity in subjects with heart failure in comparison to healthy control subjects. J Nucl Cardiol. 2013 Aug;20(4):592-9. doi: 10.1007/s12350-013-9714-2. Epub 2013 Apr 30.
citation: Gerson MC, Caldwell JH, Ananthasubramaniam K, Clements IP, Henzlova MJ, Amanullah A, Jacobson AF. Influence of diabetes mellitus on prognostic utility of imaging of myocardial sympathetic innervation in heart failure patients. Circ Cardiovasc Imaging. 2011 Mar;4(2):87-93. doi: 10.1161/CIRCIMAGING.110.954784. Epub 2010 Dec 30.
citation: Mushtaq N, Gerson MC. I-123 metaiodobenzylguanidine imaging in non-insulin-dependent diabetic patients with normal myocardial perfusion scans: new insights into their increased cardiac morbidity and mortality rates. J Nucl Cardiol. 2006 Jan-Feb;13(1):8-10. doi: 10.1016/j.nuclcard.2005.11.005. No abstract available.
citation: Gerson MC, Wagoner LE, McGuire N, Liggett SB. Activity of the uptake-1 norepinephrine transporter as measured by I-123 MIBG in heart failure patients with a loss-of-function polymorphism of the presynaptic alpha2C-adrenergic receptor. J Nucl Cardiol. 2003 Nov-Dec;10(6):583-9. doi: 10.1016/j.nuclcard.2003.07.001.
citation: Gerson MC, Craft LL, McGuire N, Suresh DP, Abraham WT, Wagoner LE. Carvedilol improves left ventricular function in heart failure patients with idiopathic dilated cardiomyopathy and a wide range of sympathetic nervous system function as measured by iodine 123 metaiodobenzylguanidine. J Nucl Cardiol. 2002 Nov-Dec;9(6):608-15. doi: 10.1067/mnc.2002.127717.
citation: Abdallah M, Gerson MC. A step forward in the use of SPECT imaging with I-123 MIBG. J Nucl Cardiol. 2012 Feb;19(1):16-8. doi: 10.1007/s12350-011-9495-4. No abstract available.
citation: Kubo A, Hung YY, Ritterman J. Yoga for heart failure patients: a feasibility pilot study with a multiethnic population. Int J Yoga Therap. 2011;(21):77-83.
citation: Barclay S, Momen N, Case-Upton S, Kuhn I, Smith E. End-of-life care conversations with heart failure patients: a systematic literature review and narrative synthesis. Br J Gen Pract. 2011 Jan;61(582):e49-62. doi: 10.3399/bjgp11X549018.
citation: Heidenreich PA, Trogdon JG, Khavjou OA, Butler J, Dracup K, Ezekowitz MD, Finkelstein EA, Hong Y, Johnston SC, Khera A, Lloyd-Jones DM, Nelson SA, Nichol G, Orenstein D, Wilson PW, Woo YJ; American Heart Association Advocacy Coordinating Committee; Stroke Council; Council on Cardiovascular Radiology and Intervention; Council on Clinical Cardiology; Council on Epidemiology and Prevention; Council on Arteriosclerosis; Thrombosis and Vascular Biology; Council on Cardiopulmonary; Critical Care; Perioperative and Resuscitation; Council on Cardiovascular Nursing; Council on the Kidney in Cardiovascular Disease; Council on Cardiovascular Surgery and Anesthesia, and Interdisciplinary Council on Quality of Care and Outcomes Research. Forecasting the future of cardiovascular disease in the United States: a policy statement from the American Heart Association. Circulation. 2011 Mar 1;123(8):933-44. doi: 10.1161/CIR.0b013e31820a55f5. Epub 2011 Jan 24.