The Effect of Yoga on Cardiac Sympathetic Innervation Evaluated by I-123 mIBG
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Cardiac sympathetic activity following yoga training
研究概览
简要总结
The purpose of this study is to evaluate if yoga practice will reduce cardiac sympathetic activity and subsequently cardiac arrhythmias.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
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.
干预措施: Yoga training (Behavioral)
结局指标
主要结局
Cardiac sympathetic activity following yoga training
时间窗: 8 weeks
A comparison of of the I-123 MIBG heart to mediastinal uptake ratio at baseline and completion of the yoga training.
次要结局
- Relationship between I-123MIBG heart-to-mediastinal ratios and the total atrial and ventricular arrhythmia burden.(8 weeks)
研究者
Mehran Attari
Professor of Medicine
University of Cincinnati