Heart Failure, SystolicNCT03227393
The Effect of Yoga on Cardiac Sympathetic Innervation Evaluated by I-123 mIBG
A study testing Yoga training in people with Heart Failure, Systolic, run by University of Cincinnati at 1 site in United States.
Trial summary
The purpose of this study is to evaluate if yoga practice will reduce cardiac sympathetic activity and subsequently cardiac arrhythmias. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Systolic
- What is being tested?
- Yoga training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2017to 27 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
About this study
The purpose of this study is to evaluate if yoga practice will reduce cardiac sympathetic activity and subsequently cardiac arrhythmias.
Read the 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.
- Conditions
- Heart Failure, Systolic
- Being tested
- Yoga training
- Keywords
- Heart Failure, Systolic, Defibrillators, Implantable, Pacemaker, Artificial
- Medical subject headings
- Heart Failure, Systolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga trainingBehavioural
Subjects will complete in class yoga training weekly for 8 weeks with additional practice at home
| Study group | Role | What they receive |
|---|---|---|
| No yoga training | No intervention | 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 | Experimental | 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. Receives: Behavioral: Yoga training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (1)
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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study start30 Sep 2017
- Primary completion27 Oct 2017
- Study completion27 Oct 2017
Why it stopped: Study was not opened at site.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (46)Papers the sponsor has linked to this study.
- Other trials for Heart Failure, SystolicStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehran Attari, University of Cincinnati
- Investigators
- Mehran Attari, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03227393
- Sponsor's protocol ID
- 2015-7643
- Status last verified
- Mar 2018
- First submitted
- 20 Jul 2017
- Last updated
- 20 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Roger VL, Go AS, Lloyd-Jones DM, Benjamin EJ, Berry JD, Borden WB, Bravata DM, Dai S, Ford ES, Fox CS, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Makuc DM, Marcus GM, Marelli A, Matchar DB, Moy CS, Mozaffarian D, Mussolino ME, Nichol G, Paynter NP, Soliman EZ, Sorlie PD, Sotoodehnia N, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2012 update: a report from the American Heart Association. Circulation. 2012 Jan 3;125(1):e2-e220. doi: 10.1161/CIR.0b013e31823ac046. Epub 2011 Dec 15. No abstract available.
PubMed 22179539Thrall G, Lip GY, Carroll D, Lane D. Depression, anxiety, and quality of life in patients with atrial fibrillation. Chest. 2007 Oct;132(4):1259-64. doi: 10.1378/chest.07-0036. Epub 2007 Jul 23.
PubMed 17646231Fuster V, Ryden LE, Cannom DS, Crijns HJ, Curtis AB, Ellenbogen KA, Halperin JL, Kay GN, Le Huezey JY, Lowe JE, Olsson SB, Prystowsky EN, Tamargo JL, Wann LS. 2011 ACCF/AHA/HRS focused updates incorporated into the ACC/AHA/ESC 2006 Guidelines for the management of patients with atrial fibrillation: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines developed in partnership with the European Society of Cardiology and in collaboration with the European Heart Rhythm Association and the Heart Rhythm Society. J Am Coll Cardiol. 2011 Mar 15;57(11):e101-98. doi: 10.1016/j.jacc.2010.09.013. No abstract available.
PubMed 21392637Cheriyath P, He F, Peters I, Li X, Alagona P Jr, Wu C, Pu M, Cascio WE, Liao D. Relation of atrial and/or ventricular premature complexes on a two-minute rhythm strip to the risk of sudden cardiac death (the Atherosclerosis Risk in Communities [ARIC] study). Am J Cardiol. 2011 Jan 15;107(2):151-5. doi: 10.1016/j.amjcard.2010.09.002.
PubMed 21211594Florea VG, Cohn JN. The autonomic nervous system and heart failure. Circ Res. 2014 May 23;114(11):1815-26. doi: 10.1161/CIRCRESAHA.114.302589.
PubMed 24855204La Rovere MT, Pinna GD, Hohnloser SH, Marcus FI, Mortara A, Nohara R, Bigger JT Jr, Camm AJ, Schwartz PJ; ATRAMI Investigators. Autonomic Tone and Reflexes After Myocardial Infarcton. Baroreflex sensitivity and heart rate variability in the identification of patients at risk for life-threatening arrhythmias: implications for clinical trials. Circulation. 2001 Apr 24;103(16):2072-7. doi: 10.1161/01.cir.103.16.2072.
PubMed 11319197La Rovere MT, Pinna GD, Maestri R, Mortara A, Capomolla S, Febo O, Ferrari R, Franchini M, Gnemmi M, Opasich C, Riccardi PG, Traversi E, Cobelli F. Short-term heart rate variability strongly predicts sudden cardiac death in chronic heart failure patients. Circulation. 2003 Feb 4;107(4):565-70. doi: 10.1161/01.cir.0000047275.25795.17.
PubMed 12566367Mitrani RD, Klein LS, Miles WM, Hackett FK, Burt RW, Wellman HN, Zipes DP. Regional cardiac sympathetic denervation in patients with ventricular tachycardia in the absence of coronary artery disease. J Am Coll Cardiol. 1993 Nov 1;22(5):1344-53. doi: 10.1016/0735-1097(93)90541-8.
PubMed 8227790Paul M, Schafers M, Kies P, Acil T, Schafers K, Breithardt G, Schober O, Wichter T. Impact of sympathetic innervation on recurrent life-threatening arrhythmias in the follow-up of patients with idiopathic ventricular fibrillation. Eur J Nucl Med Mol Imaging. 2006 Aug;33(8):866-70. doi: 10.1007/s00259-005-0061-7. Epub 2006 Apr 13.
PubMed 16612587Patterson E, Po SS, Scherlag BJ, Lazzara R. Triggered firing in pulmonary veins initiated by in vitro autonomic nerve stimulation. Heart Rhythm. 2005 Jun;2(6):624-31. doi: 10.1016/j.hrthm.2005.02.012.
PubMed 15922271Coccagna G, Capucci A, Bauleo S, Boriani G, Santarelli A. Paroxysmal atrial fibrillation in sleep. Sleep. 1997 Jun;20(6):396-8. doi: 10.1093/sleep/20.6.396.
PubMed 9302722Po SS, Yu L, Scherlag BJ. Cardiac autonomic nervous system: a tug of war between the big brain and little brain--friends or foes? Heart Rhythm. 2009 Dec;6(12):1780-1. doi: 10.1016/j.hrthm.2009.09.006. Epub 2009 Sep 6. No abstract available.
PubMed 19959129Shen MJ, Shinohara T, Park HW, Frick K, Ice DS, Choi EK, Han S, Maruyama M, Sharma R, Shen C, Fishbein MC, Chen LS, Lopshire JC, Zipes DP, Lin SF, Chen PS. Continuous low-level vagus nerve stimulation reduces stellate ganglion nerve activity and paroxysmal atrial tachyarrhythmias in ambulatory canines. Circulation. 2011 May 24;123(20):2204-12. doi: 10.1161/CIRCULATIONAHA.111.018028. Epub 2011 May 9.
PubMed 21555706Collura CA, Johnson JN, Moir C, Ackerman MJ. Left cardiac sympathetic denervation for the treatment of long QT syndrome and catecholaminergic polymorphic ventricular tachycardia using video-assisted thoracic surgery. Heart Rhythm. 2009 Jun;6(6):752-9. doi: 10.1016/j.hrthm.2009.03.024. Epub 2009 Mar 19.
PubMed 19467503Schwartz PJ, Priori SG, Cerrone M, Spazzolini C, Odero A, Napolitano C, Bloise R, De Ferrari GM, Klersy C, Moss AJ, Zareba W, Robinson JL, Hall WJ, Brink PA, Toivonen L, Epstein AE, Li C, Hu D. Left cardiac sympathetic denervation in the management of high-risk patients affected by the long-QT syndrome. Circulation. 2004 Apr 20;109(15):1826-33. doi: 10.1161/01.CIR.0000125523.14403.1E. Epub 2004 Mar 29.
PubMed 15051644
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Yoga on Cardiac Sympathetic Innervation Evaluated by I-123 mIBG
- ClinicalTrials.gov ID
- NCT03227393
- Acronym / sponsor ID
- 2015-7643
- Conditions
- Heart Failure, Systolic
- Keywords
- Heart Failure, Systolic, Defibrillators, Implantable, Pacemaker, Artificial
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was not opened at site.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- 30 Sep 2017 (actual)
- Primary completion
- 27 Oct 2017 (actual)
- Study completion
- 27 Oct 2017 (actual)
- First posted
- 24 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No yoga training | No intervention | –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 | Experimental | Behavioral: Yoga trainingThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yoga trainingSubjects will complete in class yoga training weekly for 8 weeks with additional practice at home | Behavioural | Yoga training |
Primary outcome
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.
1 secondary outcome
Relationship between I-123MIBG heart-to-mediastinal ratios and the total atrial and ventricular arrhythmia burden.
Time frame: 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2018.
- Background: PubMed 22179539Roger VL, Go AS, Lloyd-Jones DM, Benjamin EJ, Berry JD, Borden WB, Bravata DM, Dai S, Ford ES, Fox CS, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Makuc DM, Marcus GM, Marelli A, Matchar DB, Moy CS, Mozaffarian D, Mussolino ME, Nichol G, Paynter NP, Soliman EZ, Sorlie PD, Sotoodehnia N, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2012 update: a report from the American Heart Association. Circulation. 2012 Jan 3;125(1):e2-e220. doi: 10.1161/CIR.0b013e31823ac046. Epub 2011 Dec 15. No abstract available.
- Background: PubMed 17646231Thrall G, Lip GY, Carroll D, Lane D. Depression, anxiety, and quality of life in patients with atrial fibrillation. Chest. 2007 Oct;132(4):1259-64. doi: 10.1378/chest.07-0036. Epub 2007 Jul 23.
- Background: PubMed 21392637Fuster V, Ryden LE, Cannom DS, Crijns HJ, Curtis AB, Ellenbogen KA, Halperin JL, Kay GN, Le Huezey JY, Lowe JE, Olsson SB, Prystowsky EN, Tamargo JL, Wann LS. 2011 ACCF/AHA/HRS focused updates incorporated into the ACC/AHA/ESC 2006 Guidelines for the management of patients with atrial fibrillation: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines developed in partnership with the European Society of Cardiology and in collaboration with the European Heart Rhythm Association and the Heart Rhythm Society. J Am Coll Cardiol. 2011 Mar 15;57(11):e101-98. doi: 10.1016/j.jacc.2010.09.013. No abstract available.
- Background: PubMed 21211594Cheriyath P, He F, Peters I, Li X, Alagona P Jr, Wu C, Pu M, Cascio WE, Liao D. Relation of atrial and/or ventricular premature complexes on a two-minute rhythm strip to the risk of sudden cardiac death (the Atherosclerosis Risk in Communities [ARIC] study). Am J Cardiol. 2011 Jan 15;107(2):151-5. doi: 10.1016/j.amjcard.2010.09.002.
- Background: PubMed 24855204Florea VG, Cohn JN. The autonomic nervous system and heart failure. Circ Res. 2014 May 23;114(11):1815-26. doi: 10.1161/CIRCRESAHA.114.302589.
- Background: PubMed 11319197La Rovere MT, Pinna GD, Hohnloser SH, Marcus FI, Mortara A, Nohara R, Bigger JT Jr, Camm AJ, Schwartz PJ; ATRAMI Investigators. Autonomic Tone and Reflexes After Myocardial Infarcton. Baroreflex sensitivity and heart rate variability in the identification of patients at risk for life-threatening arrhythmias: implications for clinical trials. Circulation. 2001 Apr 24;103(16):2072-7. doi: 10.1161/01.cir.103.16.2072.
- Background: PubMed 12566367La Rovere MT, Pinna GD, Maestri R, Mortara A, Capomolla S, Febo O, Ferrari R, Franchini M, Gnemmi M, Opasich C, Riccardi PG, Traversi E, Cobelli F. Short-term heart rate variability strongly predicts sudden cardiac death in chronic heart failure patients. Circulation. 2003 Feb 4;107(4):565-70. doi: 10.1161/01.cir.0000047275.25795.17.
- Background: PubMed 8227790Mitrani RD, Klein LS, Miles WM, Hackett FK, Burt RW, Wellman HN, Zipes DP. Regional cardiac sympathetic denervation in patients with ventricular tachycardia in the absence of coronary artery disease. J Am Coll Cardiol. 1993 Nov 1;22(5):1344-53. doi: 10.1016/0735-1097(93)90541-8.
- Background: PubMed 16612587Paul M, Schafers M, Kies P, Acil T, Schafers K, Breithardt G, Schober O, Wichter T. Impact of sympathetic innervation on recurrent life-threatening arrhythmias in the follow-up of patients with idiopathic ventricular fibrillation. Eur J Nucl Med Mol Imaging. 2006 Aug;33(8):866-70. doi: 10.1007/s00259-005-0061-7. Epub 2006 Apr 13.
- Background: PubMed 15922271Patterson E, Po SS, Scherlag BJ, Lazzara R. Triggered firing in pulmonary veins initiated by in vitro autonomic nerve stimulation. Heart Rhythm. 2005 Jun;2(6):624-31. doi: 10.1016/j.hrthm.2005.02.012.
- Background: PubMed 9302722Coccagna G, Capucci A, Bauleo S, Boriani G, Santarelli A. Paroxysmal atrial fibrillation in sleep. Sleep. 1997 Jun;20(6):396-8. doi: 10.1093/sleep/20.6.396.
- Background: PubMed 19959129Po SS, Yu L, Scherlag BJ. Cardiac autonomic nervous system: a tug of war between the big brain and little brain--friends or foes? Heart Rhythm. 2009 Dec;6(12):1780-1. doi: 10.1016/j.hrthm.2009.09.006. Epub 2009 Sep 6. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehran Attari principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga training in people with Heart Failure, Systolic, run by University of Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac sympathetic activity following yoga training (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03227393, which also lists 46 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2018.