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

Not Applicable

Withdrawn

• Conditions: Heart Failure, Systolic
• Interventions: Behavioral: Yoga training

• Registration Number: NCT03227393
• Lead Sponsor: University of Cincinnati

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.

Study Timeline

• Study First Submitted: 2017-07-20
• Study First Submitted QC: 2017-07-20
• Study First Posted: 2017-07-24
• Study Start: 2017-09-30
• Primary Completion: 2017-10-27
• Study Completion: 2017-10-27
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-18
• Last Update Posted: 2018-03-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Yoga training	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

University of Cincinnati Medical Center; 🇺🇸 Cincinnati, Ohio, United States