Health Condition 1: I509- Heart failure, unspecified
Conditions
Sponsors
Centre for Chronic Disease Control
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 1 Comorbid disease or behavioural or other limitations that interfere with 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 monthsTimepoint: Co-primary outcome-1 Median follow-up of one year and Co-primary outcome-1 Three months | — |
Secondary
| Measure | Time frame |
|---|---|
| Adherence to prescribed therapyTimepoint: Three months and final follow-up (median 1 year);Cardiovascular mortality at end of trial follow-upTimepoint: Median Follow-up 1 year;Cost effectivenessTimepoint: Median Follow-up 1 year;Heart Failure Specific Hospitalisation at end of trial follow-upTimepoint: Median Follow-up 1 year;Quality of life and depression among care-giversTimepoint: 3 months and 6 months;Quality of life as measured by MLHFQTimepoint: 6 months and 12 months;Safety outcomesTimepoint: Median Follow-up 1 year;Self rated health as measured by European Quality of Life Questionnare EQ-5D-5LTimepoint: 3 and 6 months;Self reported frailty as reported by Fried Frailty Phenotype toolTimepoint: 3 and 6 months;Six-minute walk test 6MWTTimepoint: 3 and 6 months;Smoking CessationTimepoint: 3 months and 1 year | — |
Countries
India
Contacts
Public ContactDr Chandrasekaran BNYS MPH
Centre for Chronic Disease Control
Outcome results
None listed