The Effect of Yoga on Cardiac Sympathetic Innervation Evaluated by I-123 mIBG

Study Overview
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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.

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.

Official Title
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The Effect of Yoga on Cardiac Sympathetic Innervation Evaluated by I-123 mIBG

Conditions
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Heart Failure, Systolic

Intervention / Treatment
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* Behavioral: Yoga training


Participation Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No yoga training<br>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. | |
| Experimental: Yoga training<br>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. | Behavioral: Yoga training<br>* Subjects will complete in class yoga training weekly for 8 weeks with additional practice at home<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac sympathetic activity following yoga training | A comparison of of the I-123 MIBG heart to mediastinal uptake ratio at baseline and completion of the yoga training. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship between I-123MIBG heart-to-mediastinal ratios and the total atrial and ventricular arrhythmia burden. | Association between heart to mediastinum ration and ventricular arrhythmia burden | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure, Systolic, Defibrillators, Implantable, Pacemaker, Artificial