This study aims to test if S-adenosylmethionine can be a safe and effective addition to standard Chronic Heart Failure treatment in humans, potentially offering a new approach to managing this condition with fewer side effects.

Phase 4

• Conditions: Health Condition 1: I509- Heart failure, unspecified

• Registration Number: CTRI/2024/01/061494
• Lead Sponsor: ICMR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

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 <0.5 mIU/L)

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 <60 ml/min),

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of hospitalisation in both groupsTimepoint: From baseline to 12 months

Secondary Outcome Measures

Name	Time	Method
Efficacy biomarkers (Serum homocysteine, GSH, TNF-a, IL-6 ,SAMe, SAH & 5- <br/ ><br>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, <br/ ><br>Lipid profile)Timepoint: from baseline to 6 and 12 months <br/ ><br>