Health Condition 1: I509- Heart failure, unspecified
Conditions
Interventions
Intervention1: S Adenosyl Methionine plus Standard of care (Tab. Sacubitril- Valsartan,
Tab. Metoprolol XR,
Tab Dapagliflozin/ Empagliflozin ,
Tab Spironolactone: •Tab SAM 400 mg twice a day,
• Tab.
Sponsors
ICMR
Eligibility
Inclusion criteria
Inclusion criteria: 1. Ambulatory CHF patients of both genders, 2. Age = 18 years, 3. Having a left ventricular ejection fraction (LVEF) 30% to 50% on 2D-echocardiography assessed within 12 months prior to randomization (most recent measurement must be used to determine eligibility). 4. NYHA functional class I, class II and Class III symptoms for the past three months 5. No history of hospitalization in last 3 months 6. Willing to give written informed consent 7. Patients having increased levels of Pro BNP more than 125 pg/mL and Serum 8. Homocysteine level above 15 micromoles per litre (mcmol/L).
Exclusion criteria
Exclusion criteria: 1. Patients with acute decompensated heart failure or recent hospitalization for heart failure (in the preceding 4 weeks) 2. History of myocardial infarction or unstable angina (in the preceding 4 weeks) 3. Stroke or transient ischemic attack (in the preceding 6 months) 4. Cardiac revascularization procedures (in the preceding 3 months) 5. A planned cardiac revascularization (in succeeding 3 months) 6. NYHA functional class IV symptoms 7. Primary valvular heart disease 8. Evidence of myocarditis, arteritis or coarctation of aorta 9. Uncontrolled hypertension (BP > 160/110 mm of hg) 10. Hyperthyroidism (serum TSH > 4 mIU/L)and 10. 11. Hypothyroidism(serum TSH 12. Liver dysfunction (serum bilirubin > 1.5 times upper limit of normal or serum transaminases > 3 times upper limit of normal) 13. Renal dysfunction (serum creatinine > 1.5 mg/dl and eGFR 14. Patients with known allergies or sensitivities to SAM or its components 15. Patients with severe psychiatric disorder that may affect their ability to participate in the study or comply with medication regimens. 16. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate and highly effective contraceptive method. 17. Patients with active alcohol or substance abuse disorders 18. Consumed any other investigational drug or enrolled in any other study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of hospitalisation in both groupsTimepoint: From baseline to 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy biomarkers (Serum homocysteine, GSH, TNF-a, IL-6 ,SAMe, SAH & 5- methylcytosine)Timepoint: From baseline to 6 and 12 months;Incidence of hospitalisation in both groupsTimepoint: from baseline to 1,2,3,6 and 9 months;Left ventricular ejection fractionTimepoint: from baseline to 6 months and 12 months;Quality of life using Minnesota Living with Heart Failure Quality of Life (MLHFQL) and Heart Failure Symptom Survey (HFSS)Timepoint: from baseline to 1,2,3,6,9 and 12 months;Safety Variables (Hb, CBC, SGOP SGPT, Sr. Bilirubin, Sr. Creatinine, BUN, Lipid profile)Timepoint: from baseline to 6 and 12 months | — |
Countries
India
Contacts
Public ContactDr Sharmila Jalgaonkar
Seth GSMC and KEMH
Outcome results
None listed