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

University of Cincinnati

Status: Withdrawn

Conditions: Heart Failure, Systolic

Treatments: Behavioral: Yoga training

Study type: Interventional

Funder types: Other

Identifiers

NCT03227393

2015-7643

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

No yoga training

No Intervention group

Description:

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.

Yoga training

Experimental group

Description:

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.

Treatment:

Behavioral: Yoga training