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

March 18, 2018 updated by: Mehran Attari, University of Cincinnati
The purpose of this study is to evaluate if yoga practice will reduce cardiac sympathetic activity and subsequently cardiac arrhythmias.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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.
Experimental: 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.
Behavioral: Yoga training
Subjects will complete in class yoga training weekly for 8 weeks with additional practice at home

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac sympathetic activity following yoga training
Time Frame: 8 weeks
A comparison of of the I-123 MIBG heart to mediastinal uptake ratio at baseline and completion of the yoga training.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relationship between I-123MIBG heart-to-mediastinal ratios and the total atrial and ventricular arrhythmia burden.
Time Frame: 8 weeks
Association between heart to mediastinum ration and ventricular arrhythmia burden
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cincinnati

Investigators

  • Principal Investigator: Mehran Attari, University of Cincinnati

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2017

Primary Completion (Actual)

October 27, 2017

Study Completion (Actual)

October 27, 2017

Study Registration Dates

First Submitted

July 20, 2017

First Submitted That Met QC Criteria

July 20, 2017

First Posted (Actual)

July 24, 2017

Study Record Updates

Last Update Posted (Actual)

March 20, 2018

Last Update Submitted That Met QC Criteria

March 18, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-7643

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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