Randomized Trial to study the effect of lifestyle Management through Indian System of Medicine including Yoga in heart failure patients along with standard care in modern medicine
- Conditions
- Health Condition 1: null- Heart Failure Patients
- Registration Number
- CTRI/2018/05/013605
- Lead Sponsor
- Department of Science and Technology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Adult (18-70 years) Male / Female patients visiting the Cardiology OPD
Participant willing to give informed consent and to come for follow up
Patient with left ventricular dysfunction with NYHA class I& II with EF <50%
Exercise capacity (ability to walk on level ground at own pace for 5 minutes at least, able to do household) and self care work so as to ensure reasonable exercise capacity and exclude sick patients
Patient already recruited for other trials.
Inability to comply with the protocol or not willing to give consent.
Pregnancy and lactation.
Patients with NYHA class III &IV.
Past 3 months h/o or planned for re-vascularisation CABG/ PTCA in next 3 months.
Patient with h/o unstable angina in last three months.
Other major organ dysfunction like renal dysfunction (Blood Urea >50 mg%, S.Creatinine >1.8 mg%) & hepatic dysfunction (AST/ ALT/ ALP/ Total S. Bilirubin > 3 times the upper normal limit )
With other co-morbid conditions like uncontrolled diabetes mellitus, hypertension and malignancy.
Any other condition which the investigator thinks may jeopardize the study.
Psychiatric disease, Participated in similar study previously ,Chronic kidney disease
Active liver disease.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Outcome: <br/ ><br>Quality of Life (Kansas City Cardiomyopathy Questionnaire) <br/ ><br>Timepoint: Base line and Six Months
- Secondary Outcome Measures
Name Time Method <br/ ><br>1. Functional capacity (NYHA and 6 minute walk test) <br/ ><br>2. Safety (compliance, drop outs) <br/ ><br>3.Clinical Outcomes (Hospital Visits, emergency room visits, admissions, mortality, blood pressure, heart rate, body weight) <br/ ><br> 4. Cardiac function (echo-cardiography) <br/ ><br>5. Biochemical outcomes (ST2 ,Pro NT-BNP, Inflammatory [IL-6], Oxidative stress [Super oxide dismutase] and other markers, lipids and blood sugar) <br/ ><br>Timepoint: Base line and Six Months