The Effect of Yoga on Cardiac Sympathetic Innervation Evaluated by I-123 mIBG
NCT ID: NCT03227393
Last Updated: 2018-03-20
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
WITHDRAWN
Clinical Phase
NA
Study Classification
INTERVENTIONAL
Study Start Date
2017-09-30
Study Completion Date
2017-10-27
Brief Summary
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The purpose of this study is to evaluate if yoga practice will reduce cardiac sympathetic activity and subsequently cardiac arrhythmias.
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Detailed Description
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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.
Conditions
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Heart Failure, Systolic
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
SUPPORTIVE_CARE
Blinding Strategy
SINGLE
Investigators
Study Groups
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No yoga training
This will be the control arm. The patients in this arm will not receive any yoga training. They will be continued on all their home, guideline-directed heart failure medications. They will undergo the same baseline and study completion evaluation as the treatment arm, including an I-123 MIBG scan, 24-hour holter monitoring and device interrogation.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Yoga training
The patients in this arm will receive yoga training. This includes weekly group yoga sessions consisting of breathing exercises, yoga poses, and relaxation and meditation lasting for about 80-90 minutes total. Patients will be asked to do home yoga practices at least twice a week and to document the date and time. Patients in this arm will have the same baseline and study completion evaluation as the control arm, including an I-123 MIBG scan, 24-hour holter monitoring and device interrogation.
Group Type
EXPERIMENTAL
Yoga training
Intervention Type
BEHAVIORAL
Subjects will complete in class yoga training weekly for 8 weeks with additional practice at home
Interventions
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Yoga training
Subjects will complete in class yoga training weekly for 8 weeks with additional practice at home
Intervention Type
BEHAVIORAL
Eligibility Criteria
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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
* 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
* 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
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University of Cincinnati
OTHER
Sponsor Role
lead
Responsible Party
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Mehran Attari
Professor of Medicine
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Mehran Attari
Role: PRINCIPAL_INVESTIGATOR
University of Cincinnati
Locations
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University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Site Status
Countries
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United States
References
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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.
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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.
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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.
Reference Type
BACKGROUND
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
RESULT
Other Identifiers
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2015-7643
Identifier Type: -
Identifier Source: org_study_id
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