Health Condition 1: I219- Acute myocardial infarction, unspecified
Conditions
Interventions
Intervention1: Fixed-Dose Combination of Dapagliflozin 10 mg and Metoprolol 50 mg XR tablets: One tablet daily in morning two to three (2-3) hours after breakfast daily for 180 days
Control Interventi
Sponsors
ERIS LIFESCIENCES LIMITED
ERIS LIFESCIENCES LIMITED
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects of either sex having age >18years at the time of screening. 2. Adult subjects who are capable of understanding and giving written informed consent and willing to comply with the study protocol. 3. Subjects diagnosed established documented diagnosis of symptomatic HF [New York Heart Association (NYHA) functional class II-III] with recent history of ( 1 year. 4. Should have been under treatment with optimized standard doses of guideline directed medical therapy which may contain combination of drugs from medication classes suggested in standard guidelines for treatment of HF [â??diureticâ?? and â??ACE inhibitorâ?? OR â??ARBâ?? and a â??beta-blockerâ?? and a â??mineralocorticoid receptor antagonist (only if considered appropriate by the treating physician)â??]. Therapy should have been individually optimized and stable for >=4 weeks (this does not apply to diuretics). NB: -Patients who have not received beta-blockers prior to Screening shall be initiated on low dose beta-blocker treatment followed by dose up titration during Screening Phase (Day -28 to Day 0). -Patients should demonstrate stable heart rate on Metoprolol 50mg daily dose at the time of randomization in 2 out of 3 measurements. -Most patients with heart failure require treatment with a diuretic to control sodium and water retention leading to volume overload. It is recognized that diuretic dosing may be titrated to symptoms, signs, weight and other information and may thus vary. Each patient should, however, be treated with a diuretic regimen aimed at achieving optimal fluid/volume status for that individual. -Patients in whom any additional pharmacological or device therapy is contemplated or should be considered, must not be enrolled until therapy has been optimized and is stable for >=4 weeks -Guideline-recommended medications should be used at recommended doses unless contraindicated or not tolerated 5. Increased N-terminal pro-B- levels at the time of screening. 6. Mildly reduced or reduced ejection fraction -If there is more than one assessment of LVEF the value from the most recent measurement should be used in assessing eligibility. -2D-ECHO reports from within last 8 weeks are acceptable. In case imaging reports are older, 2D-ECHO to be repeated locally at the time of screening to establish baseline. 7. Females of non-child bearing potential (surgically sterile or menopausal) OR females of child bearing potential using effective birth control measures and non-pregnant & non-lactating females.
Exclusion criteria
Exclusion criteria: 1. Subjects previously sensitive to any of the ingredients of the fixed-dose combination under study or beta-blockers or SGLT2 Inhibitors 2. Subjects with past history or present symptoms of Bradycardia [Pulse rate 3. Subjects with history of Bronchial Asthma & COPD. 4. Subjects with history or present symptoms of recurrent UTI infections. 5.Subjects receiving treatment with SGLT2 inhibitors within 8 weeks prior to enrolment. 6. Stroke or transient ischemic attack within 12 weeks prior to enrollment 7. Type-1 Diabetes Mellitus patients 8. Type-2 Diabetes Mellitus patients with frequent episodes of hypoglycemia [Patients with type 2 diabetes mellitus continue to take their glucose lowering therapy but doses could be adjusted as required. Specifically the doses of insulin and sulfonylureas could be reduced to minimize the risk of hypoglycemia] 9. Current acute decompensated HF or hospitalization due to decompensated HF 10. Cardiac CRT implantation within 12 weeks or intended to implant prior to enrollment 11. Previous cardiac transplantation or implantation of a ventricular assisted device (VAD) or similar device, or implantation expected after randomization. 12. Symptomatic bradycardia or second- or third-degree heart block without a pacemaker. 13. Active malignancy requiring treatment at the time of visit 1 (with the exception of successfully treated basal cell or treated squamous cell carcinoma) or any history of malignancy 14. Subjects with clinically significant renal disorders: -Estimated glomerular filtration rate: -Subjects with S. Creatinine values and S.BUN values >= 1.5 times the upper limit of normal. 15. Subjects with hepatocellular insufficiency and in subjects with hepatic failure or active liver disease [abnormal Liver Function Test with values more than 3 times the upper limit of normal]. 16. Subjects with EF 17. Any known cardiac disease/disorder in which any of the study medication is contra-indicated (e.g. severe bradycardia, heart block greater than a first degree or significant first-degree block, cardiogenic shock, decompensated cardiac failure, sick sinus syndrome without pacemaker etc.). 18. Subjects with known significant respiratory/ liver/ kidney/ neurological diseases/ uncontrolled diabetes. 19. Pregnant and lactating women or the women of child bearing age who are not practicing the effective means of contraception. 20. Subjects otherwise judged to be inappropriate for inclusion in the study by the investigatorâ??s judgment. 21.Subjects who will receive some other drug during the study besides that in the protocol that could alter the pharmacokinetic/ pharmacodynamic profile of the study drug. 22.Subjects with known alcohol or drug abuse. 23.Chronic use of Non-steroidal anti-inflammatory drugs (NSAIDS) as they cause fluid retention 24.Subjects with known History or active HIV, Hepatitis B
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects achieving at one class symptomatic improvement from baseline in New York Heart Association (NYHA) functional classification for Heart Failure Proportion of patients showing improvement in LVEFTimepoint: 180 days Baseline, 180 day | — |
Secondary
| Measure | Time frame |
|---|---|
| 6-min walk testTimepoint: Till 180 days;Alteration in quality of life using Kansas City Cardiomyopathy questionnaireTimepoint: Till 180 days;Mean reduction in NT-pro BNP levels from baselineTimepoint: Baseline, day 90 and day 180 ;Worsening heart failure (hospitalization or an urgent visit resulting in intravenous therapy for heart failure or death from cardiovascular causes)Timepoint: Till 180 days | — |
Countries
India
Contacts
Public ContactKartik Sahni
Insignia Clinical Services Pvt Ltd.
Outcome results
None listed