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

Sponsor

University of Cincinnati (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03227393

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Days)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Heart Failure, Systolic	Behavioral: Yoga training	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Sep 30, 2017

Actual Primary Completion Date :

Oct 27, 2017

Actual Study Completion Date :

Oct 27, 2017

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: 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.
Experimental: 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.	Behavioral: Yoga training Subjects will complete in class yoga training weekly for 8 weeks with additional practice at home

Arm

Intervention/Treatment

No Intervention: 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.

Experimental: 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.

Behavioral: Yoga training

Subjects will complete in class yoga training weekly for 8 weeks with additional practice at home

Outcome Measures

Primary Outcome Measures

Cardiac sympathetic activity following yoga training [8 weeks]
A comparison of of the I-123 MIBG heart to mediastinal uptake ratio at baseline and completion of the yoga training.

Secondary Outcome Measures

Relationship between I-123MIBG heart-to-mediastinal ratios and the total atrial and ventricular arrhythmia burden. [8 weeks]
Association between heart to mediastinum ration and ventricular arrhythmia burden

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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