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

Heart Failure, Systolic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03227393
• Other study ID #: 2015-7643
• Status: Withdrawn
• Phase: N/A
• First received: July 20, 2017
• Last updated: March 18, 2018
• Start date: September 30, 2017
• Est. completion date: October 27, 2017

Study information

• Verified date: March 2018
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 27, 2017
• Est. primary completion date: October 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Systolic

Intervention

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

Locations

Country	Name	City	State
United States	University of Cincinnati Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University of Cincinnati

Country where clinical trial is conducted

United States, 

References & Publications (46)

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* Note: There are 46 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac sympathetic activity following yoga training	A comparison of of the I-123 MIBG heart to mediastinal uptake ratio at baseline and completion of the yoga training.	8 weeks
Secondary	Relationship between I-123MIBG heart-to-mediastinal ratios and the total atrial and ventricular arrhythmia burden.	Association between heart to mediastinum ration and ventricular arrhythmia burden	8 weeks