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

Primary Purpose

Heart Failure, Systolic

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Yoga training
Sponsored by
University of Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Heart Failure, Systolic focused on measuring Heart Failure, Systolic, Defibrillators, Implantable, Pacemaker, Artificial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Cincinnati Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

No yoga training

Yoga training

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
July 20, 2017
Last Updated
March 18, 2018
Sponsor
University of Cincinnati
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1. Study Identification

Unique Protocol Identification Number
NCT03227393
Brief Title
The Effect of Yoga on Cardiac Sympathetic Innervation Evaluated by I-123 mIBG
Official Title
The Effect of Yoga on Cardiac Sympathetic Innervation Evaluated by I-123 mIBG
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Study was not opened at site.
Study Start Date
September 30, 2017 (Actual)
Primary Completion Date
October 27, 2017 (Actual)
Study Completion Date
October 27, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cincinnati

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Systolic
Keywords
Heart Failure, Systolic, Defibrillators, Implantable, Pacemaker, Artificial

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No yoga training
Arm Type
No Intervention
Arm Description
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.
Arm Title
Yoga training
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Yoga training
Intervention Description
Subjects will complete in class yoga training weekly for 8 weeks with additional practice at home
Primary Outcome Measure Information:
Title
Cardiac sympathetic activity following yoga training
Description
A comparison of of the I-123 MIBG heart to mediastinal uptake ratio at baseline and completion of the yoga training.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Relationship between I-123MIBG heart-to-mediastinal ratios and the total atrial and ventricular arrhythmia burden.
Description
Association between heart to mediastinum ration and ventricular arrhythmia burden
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehran Attari
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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The Effect of Yoga on Cardiac Sympathetic Innervation Evaluated by I-123 mIBG

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