Health Condition 1: I502- Systolic (congestive) heart failure
Conditions
Interventions
Intervention1: AZMARDA 50mg: One Tablet twice daily for 08 weeks
Control Intervention1: SACURISE 50mg: One Tablet twice daily for 08 weeks
Sponsors
Dr Sandarbh Patel
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients of either gender between 18-75 years of age with a confirmed diagnosis of HFrEF (left ventricular ejection fraction (LVEF) less than or equal to 45%), based on echocardiography. 2. Patients having a left ventricular Global Longitudinal Strain (GLS) Score of more than or equal to 15 measured through speckle-tracking echocardiography (STE) or 2D echocardiography. 3. Patients with HFrEF who have not previously been treated with Sacubitril/Valsartan 4. Patients who are on stable doses of beta blockers, mineralocorticoids and or SGLT2 inhibitors since last 4 weeks 5. Patients willing to be enrolled for the study and able to provide informed consent.
Exclusion criteria
Exclusion criteria: 1.Patient with known hypersensitivity to Sacubitril/Valsartan or any component of the formulation. 2.Patients receiving concomitant medications that interfere with Sacubitril/Valsartan. 3.Known patients with moderate renal impairment (eGFR less than 60 mL/min/1.73 m²) or significant liver disease (Child-Pugh B or C). 4.Patient with Uncontrolled hypertension (blood pressure more than 160/100 mmHg) or clinically significant arrhythmias. 5.Patients who have used Sacubitril/Valsartan within the last 4 weeks. 6.Patients who have participated in another clinical trial within the last 30 days. 7.Pregnant or breastfeeding women, or women of childbearing potential who are not using effective contraception. 8.Patients unwilling or unable to comply with the study protocol and requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the GLS score of both armsTimepoint: at the end of week 8 as compared to baseline (Day 0) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in the GLS (A2C, A4C, ALAX) score and Average Time to Peak (TTP) value of both armsTimepoint: At the end of Week 12 & 16 compared to Week 8;Change in the GLS (A2C, A4C, ALAX) score and Average TTP value of both armsTimepoint: At the end of Week 04 & 08 compared to Baseline;Change in the GLS score of both armsTimepoint: 1. At the end of Week 12 & 16 compared to Week 8 2. At the end of week 4 vs Baseline | — |
Countries
India
Contacts
Public ContactDr Jayesh Sanmukhani
Clinexcel Research
Outcome results
None listed