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CTRI Number  CTRI/2024/10/074641 [Registered on: 03/10/2024] Trial Registered Prospectively
Last Modified On: 30/09/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Other 
Public Title of Study   How Yoga based cardiac rehabilitation affects heart functioning in patients with heart failure - A study using echocardiography  
Scientific Title of Study   Effect of Yoga based Cardiac Rehabilitation (Yoga-CaRe) on Structural and Functional changes in Heart using Ballistocardiography and Echocardiography (Substudy of Yoga- CaRe HF Trial) heart using Ballistocardiography and echocardiography  
Trial Acronym  Echocardiography Sub-study 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Dorairaj Pabhakaran MD DM Msc 
Designation  Executive Director 
Affiliation  Centre for Chronic Disease Control 
Address  Centre for Chronic Disease Control Clinical Trial Department Flat number 52 second floor Block C1 Safdarjung Development Area New Delhi
Centre for Chronic Disease Control Clinical Trial Department Flat number 52 second floor Block C1 Safdarjung Development Area New Delhi
New Delhi
DELHI
110016
India 
Phone  9810118696  
Fax    
Email  dprabhakaran@ccdcindia.org  
 
Details of Contact Person
Scientific Query  
Name  Prof Dorairaj Pabhakaran MD DM Msc 
Designation  Executive Director 
Affiliation  Centre for Chronic Disease Control 
Address  Centre for Chronic Disease Control Clinical Trial Department Flat number 52 second floor Block C1 Safdarjung Development Area New Delhi
Centre for Chronic Disease Control Clinical Trial Department Flat number 52 second floor Block C1 Safdarjung Development Area New Delhi
New Delhi
DELHI
110016
India 
Phone  9810118696  
Fax    
Email  dprabhakaran@ccdcindia.org  
 
Details of Contact Person
Public Query  
Name  Dr Chandrasekaran BNYS MPH 
Designation  Programme Officer 
Affiliation  Centre for Chronic Disease Control 
Address  Centre for Chronic Disease Control Clinical Trial Department Flat number 52 second floor Block C1 Safdarjung Development Area New Delhi
Centre for Chronic Disease Control Clinical Trial Department Flat number 52 second floor Block C1 Safdarjung Development Area
South
DELHI
110016
India 
Phone  8287992563  
Fax    
Email  chandrasekaran@ccdcindia.org  
 
Source of Monetary or Material Support  
Central Council for Research in Yoga & Naturopathy 
 
Primary Sponsor  
Name  Central Council for Research in Yoga & Naturopathy 
Address  61-65, Institutional Area, Sewa Marg, Pocket D 1A, Janakpuri, New Delhi, Delhi 110058 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 9  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Bhanu Duggal  All India Institute of Medical Sciences  Department of Cardiology Virbhadra Road Shivaji Nagar near barrage sturida colony Rishikesh
Dehradun
UTTARANCHAL 		 09869418148

bhanuduggal2@gmail.com 
Dr Bhupinder Singh  All India Institute of Medical Sciences  Department of cardiology All India Institute of Medical Sciences Dabwali road Bathinda
Bathinda
PUNJAB 		 8427800682

doc_bhupi@rediffmail.com 
Dr Sunil Kumar  JSS Hospital  Department of Cardiology JSS Hospital 2nd Floor MG road Mysore
Mysore
KARNATAKA 		 08212335555

sunil_cardio@yahoo.co.in 
Dr Amit Malviya  North Eastern Indira Gandhi Regional Institute of Medical Sciences  Department of Cardiology NEIGRIMS Mawdiangdiang Shillong
East Khasi Hills
MEGHALAYA 		 08794705698

dramit_malviya@rediffmail.com 
Dr Kiran Aithal  SDM College of Medical Sciences and Hospital  Department of Medicine SDM College of Medical Sciences and Hospital SDM University Manjushree Nagar Sattur Dharwad
Dharwad
KARNATAKA 		 8362370057

drkiranaithal@yahoo.com 
Dr Prabhavathi Batt  Sri Jayadeva Institute of Cardiovascular Sciences and Research  Clinical Research Office 2nd Floor Sri Jayadeva Institute of Cardiovascular Sciences and Research Bannerghatta road 9th Block Jayanagar Bengaluru
Bangalore
KARNATAKA 		 8022977400

prabhavathi_in@yahoo.com 
Dr Sadananda  Sri Jayadeva Institute of Cardiovascular Sciences and Research  Department Clinical Research 1st Floor KRS Road Kumabara Koppalu Mysore
Mysore
KARNATAKA 		 821242150

Sadanand_dm@rediffmail.com 
Dr Nagendra Boopathy  Sri Ramachandra Institute of Higher Education and Research, Chennai  Department of Cardiology, Sri Ramachandra Medical College, Trunk Rd Sri Ramachandra Nagar Porur Chennai Tamil Nadu 600116
Chennai
TAMIL NADU 		 04446928916

srmcclinicalresearch@gmail.com 
Dr Bishav Mohan  Unit Hero DMC Heart Institute  Unite Hero DMC Heart Insititute Dayanand Medical college and Hospital Ludhiana
Ludhiana
PUNJAB 		 01612304282

bishav_68@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 9  
Name of Committee  Approval Status 
Institutional Ethics Committee - All India Institute of Medical Sciences Bhatinda  Submittted/Under Review 
Institutional Ethics Committee - All India Institute of Medical Sciences Rishikesh   Submittted/Under Review 
Institutional Ethics Committee - Dayanand Medical College Hospital  Submittted/Under Review 
Institutional Ethics Committee - JSS Hospital  Submittted/Under Review 
Institutional Ethics Committee - North Eastern Indira Gandhi Regional Institute of Medical Sciences Shillong  Submittted/Under Review 
Institutional Ethics Committee - North Eastern Sri Jayadeva Institute of Cardiovascular Sciences and Research Bengaluru  Submittted/Under Review 
Institutional Ethics Committee - SDM College of Medical Sciences & Hospital  Approved 
Institutional Ethics Committee - Sri Jayadeva Institute of Cardiovascular Sciences and Research Mysuru  Submittted/Under Review 
Institutional Ethics Committee Sri Ramachandra Institute of Higher Education and Research, Chennai  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I509||Heart failure, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Enhanced Standard Care  The participants in the control group will receive enhanced standard care which includes three educational sessions spread over three months. The educational sessions provides information on healthy life practices and heart failure specific dietary changes physical activity and stress management. The three sessions will be delivered over three months and participants are expected to practice at home regularly till the end of follow-up 
Intervention  Yoga based cardiac rehabilitaton programme for Heart Failure (Yoga-CaRe HF)   The Yoga-CaRe HF programme involves an array of health education component aiming at lifestyle changes dietary changes improving physical activity reducing stress adhering to medications and conventional management long term control of risk factors such as maintenance of healthy weight normal blood pressure and glycemic levels etc. In addition specific yoga practcies such as asana pranayama meditation and relaxative practcies will be taught in 20 sessions over a three months duration. The sessions could be in-person at the hospital and or a virtual session based on feasibility, adaptability and requirements of the participant. The supervised sessions will be supplemented by regular daily practice of yoga at home. Spouses will be encouraged to attend all the sessions and continue home practice. The training will be delivered over three months and the participants will be expected to practice by themselves till the end of the study follow-up period 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1.Male and female patients above 18years. Physician diagnosed heart failure patients based on ESC guidelines
2 Patients should be NYHA class II and or III
3 Willing and able to attend the complete hospital-based CR programme on their own

Diagnosis of Heart Failure will be based on the European Society of Cardiology ESC Guidelines. The diagnosis of HF-REF requires three conditions to be satisfied
1 Symptoms typical of Heart Failure
2 Signs typical of Heart Failure
3 Reduced Left Ventricular Ejection Fraction
 
 
ExclusionCriteria 
Details  1 Comorbid disease or behavioural or other limitations that interferew ith performing Yoga training or prevent the completion of 1 year of exercise training
2 Elective Cardiovascular procedure or hospitalization planned in the coming
3 months 3 Currently pregnant or intend to become pregnant in the next year
4 Heart failure secondary to significant correctable/reversible cause like primary valvular disease or correctable congenital heart disease
5 Performance of exercise training/yoga at regular intervals (more than once per week) at a moderate-to-vigorous intensity at any time in the previous six weeks
6 Participation in other clinical trial
 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Centralized 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Co-primary outcome -1 Major adverse cardiovascular events which is a composite of all-cause mortality, nonfatal stroke and all cause hospitalisations at a median follow-up of one year

Co-primary outcome-2 Quality of life as assessed by the Minnesota Living with Heart Failure Questionnaire MLHFQ at three months
 		 Co-primary outcome-1 Median follow-up of one year and Co-primary outcome-2 Three months 
 
Secondary Outcome  
Outcome  TimePoints 
1. Global Longitudinal strain (GLS)
2. Left Ventriculo-arterial coupling – Left VA coupling
3. Right Ventriculo-arterial coupling – Right VA coupling
4. Left ventricular ejection fraction (LVEF%)
5. Left Venricular Ejection Time
6. Tei Index. 		 We will assess the outcomes at baseline, three months to immediately after the completion of the intensive phase of the intervention and at 12 months to look at the longterm changes 
 
Target Sample Size   Total Sample Size="450"
Sample Size from India="450" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   11/10/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  Not applicable

  6. For how long will this data be available start date provided 01-03-2026 and end date provided 28-02-2031?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   400 patients with heart failure and reduced ejection fraction aged 18 and above from the ongoing Yoga-CaRe HF trial from selected tertairy centres. Yoga-CaRe HF trial is a randomzied conrtolled trial evaluating the effects of yoga based cardiac rehabilitation in patients with heart failure and reduced ejection fraction (NYHA clasee II & III) in 3500 patients recruied from 15 hospitals arooss the country. The primary outcomes are the major adverse cardiovascular events and quality of life. The trial ongoing with near 2000 participant recruitment as on 02-09-2024.

In this substudy, we will conduct an in-depth echocardiography assessment to evaluate the cardiac functions expecially on Global Longitudinal Strain (GLS), atrio-ventricular coupling and ejection fraction. Also, we will estimate the Tei Index using Dozee and validate this with the echocardiographic findings. Dozee is a non-contact sensor mat, an make in india inititative which can assist in the effective delivery of Yoga and also contact less assessment of cardiac functions working on the principles of ballistography.

These test will be conucted at baseline, three months and at six months.

These investigations will help in exploring the direct effects of Yoga-CaRe on heart functions . 
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