Health Condition 1: I502- Systolic (congestive) heart failure
Conditions
Interventions
Intervention1: Combi-kit Containing Dapagliflozin (10 mg), Bisoprolol Fumarate (1.25/2.5/5/10 mg), and Sacubitril/Valsartan (49/51 mg and 97/103 mg): Patients will be advised to take one tablet once a
Sponsors
Eris Lifesciences Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or Female Participant aged between 18 to 80 (both inclusive) years at the time of screening. 2. Participant who have diagnosed with Heart Failure with Reduced Ejection Fraction at the time of screening. 3. Participant who falls under New York Heart Association class II to III at the time of screening. 4. 4. Participant with elevated N-terminal pro-B type natriuretic peptide (NT-pro BNP) level at the time of screening visit. 5. Participant having systolic blood pressure between 100-140 mmHg and diastolic blood pressure greater than 70 mmHg. 6. Participant whose eGFR greater than or equal to 30 mL/min/1.73m . 7. Women of childbearing potential (WOCBP) must be using an acceptable method of contraception to avoid pregnancy throughout the study. WOCBP must have a negative urine pregnancy test at screening / baseline visit. 8. Participant and/or his/her legally accepted representative with the ability to understand and willing to provide a written informed consent form, which must have been obtained prior to screening. 9. Participant willing to comply with all the protocol related requirements.
Exclusion criteria
Exclusion criteria: 1. Participant with the history of type 1 diabetes mellitus or secondary diabetes mellitus. 2. Participant with a history of Angioedma. 3. Participant with a history of metabolic acidosis or diabetic ketoacidosis. 4. Participant having systolic blood pressure less than100 mmHg and diastolic blood pressure less than 70 mmHg. 5. Participant with known case of congenital renal glucosuria, history of unstable or rapidly progressing renal disease. 6. Participant with a history of severe renal impairment (eGFR Less than 30 mL/min/1.73 m2 ). 7. Participant with hypersensitivity to either of the study medications or any of its components. 8. Participant with episode of hyperkalemia (K+ greater than 5.5 mmol/L). 9. Intolerance, contraindication or potential allergy / hypersensitivity to any of the ingredients of study medication or any concomitant use of ACE inhibitor. 10. Participant with clinically significant impaired hepatic function at screening. 11. Participant with a known history of acute pancreatitis. 12. Participant with a history of anemia or hemoglobinopathy and/or hemoglobin Less than 10 g/dL for men; hemoglobin Less than 9 g/dL for women at screening. 13. Participant with known case of infection with hepatitis B, hepatitis C or HIV. 14. Participant with a history of substance abuse or dependence that in the opinion of the Investigator is considered to interfere with the participant s in the study. 15. Participant with symptomatic urinary tract infection or mycotic genital infection at screening or history of a recent symptomatic infection within 4 weeks prior to screening 16. Any other screening laboratory value that is clinically significant in the Investigator s opinion precluding participant s participation in the study. 17. Participant with concurrent participation in another clinical trial or any investigational therapy within 90 days prior to signing informed consent. 18. Pregnant or breast-feeding mother. 19. Female participant who are of childbearing potential and who are neither surgically sterilized nor willing to use reliable contraceptive methods (like hormonal, barrier methods or intrauterine devices). 20. Participant with a history of any malignancy. 21. Participant is not welling to comply with the study procedures. 22. Participant with any condition which, in the judgment of the Investigator, may render the Participant unable to complete the study or which may pose a significant risk to the patient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and type of adverse drug reactions (ADRs) related to the combination. Evaluate percentage of Participants with AE/SAE throughout the Treatment-emergent adverse events (TEAEs) as assessed at screening and Week 13. Evaluate percentage of participant with abnormal.Timepoint: Screening Visit (Days -7 to Day 0) and Visit 7: End of Study/Early Discontinuation Visit (Week 13/Day 91 3 days). | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate percentage of Participants with abnormal clinical laboratory parameters as assessed at screening and week 13.Timepoint: Screening Visit (Days -7 to Day 0) and Visit 7: End of Study/Early Discontinuation Visit (Week 13/Day 91 3 days).;Evaluate number of Participants with change in eGFR, Serum K+ throughout the studyTimepoint: Throughout the study.;Evaluate number of Participants with change in NT pro BNP level at screening and end of study.Timepoint: Screening Visit (Days -7 to Day 0) and Visit 7: End of Study/Early Discontinuation Visit (Week 13/Day 91 3 days).;Evaluate number of Participants with change in NYHA class of episodes throughout the studyTimepoint: Throughout the study.;Incidence of TEAEs leading to dose modification/ discontinuation of treatment at screening and week 13.Timepoint: Screening Visit (Days -7 to Day 0) and Visit 7: End of Study/Early Discontinuation Visit (Week 13/Day 91 3 days). | — |
Countries
India
Contacts
Public ContactMr Ganesh Boddu
Eris Lifesciences Ltd.
Outcome results
None listed