Status:
WITHDRAWN
The Effect of Yoga on Cardiac Sympathetic Innervation Evaluated by I-123 mIBG
Lead Sponsor:
University of Cincinnati
Conditions:
Heart Failure, Systolic
Eligibility:
All Genders
18+ years
Phase:
NA
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 interrogatio...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 30 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 27 2017
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03227393
Start Date
September 30 2017
End Date
October 27 2017
Last Update
March 20 2018
Active Locations (1)
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1
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45219