Heart Failure, Systolic
Conditions
Keywords
Heart Failure, Systolic, Defibrillators, Implantable, Pacemaker, Artificial
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.
Interventions
BEHAVIORALYoga training
Subjects will complete in class yoga training weekly for 8 weeks with additional practice at home
Sponsors
University of Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed