To evaluate efficacy and safety of S-Adenosyl methionine (SAM) as an add ontherapy in patients of Chronic Heart Failure (CHF): Assessor blind, Randomised, Comparative,Prospective, Proof of Concept Study. - NI

ICMR0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年1月22日

试验速览

暂无简介。

•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).

•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.

发起方

ICMR