Health Condition 1: I502- Systolic (congestive) heart failure
Conditions
Interventions
Intervention1: FDC of Eplerenone 25 mg + Torsemide 10 mg Tablets: Patients will be advised to take one tablet once daily orally, swallowed with water around same time every day for 24 weeks.
Intervent
Sponsors
Exemed Pharmaceuticals
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female patients aged more than 18 years with documented diagnosis of congestive heart failure at the time of screening visit. 2. Patients with New York Heart Association (NYHA) functional class II or III symptoms at the time of screening visit. 3. Patients with ejection fraction (EF) less than 40% at the time of screening visit. 4. Patients with a plasma level of NT-pro BNP (N-terminal pro-B type natriuretic peptide) should be more than 120 pg/mL at the time of screening visit. 5. Patients should receive a background standard of care for congestive heart failure and be treated according to locally recognized guidelines. Guideline recommended pharmacological medications should be used at recommended doses unless contraindicated or not tolerated (â??ACE inhibitor ? OR â??ARB ? and a â??beta-blocker ?). Therapy should have been individually optimized and stable for more than or equal to 4 weeks. 6. 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. 7. Patient with ability to understand and provide written informed consent form, which must have been obtained prior to screening. 8. Patients are willing to comply with the protocol requirements throughout the study.
Exclusion criteria
Exclusion criteria: 1. Patients with known hypersensitivity to study medication or related class of drugs. 2. Patients with history or present symptoms of bradycardia (pulse rate less than 60 bpm) and or hypotension (systolic blood pressure less than 95 mmHg and diastolic blood pressure less than 70 mmHg) with or without treatment with beta-blockers at 2 out of 3 measurements either at screening or randomization. 3. Patients with symptoms recent worsening heart failure or other cardiovascular events or procedures (or planned procedures). 4. Patients with hypoxia, a room air saturation of less than 95%. 5. Patients with ongoing myocardial ischemia requiring revascularization. 6. Patients with present or history of hypokalemia (serum potassium level of less than 3.5 mEq per litre) or hyperkalemia (serum potassium level of more than 5.5 mEq per litre) at screening visit. 7. Patients with hyponatremia as per blood biochemistry results at screening visit. 8. Patients with a history of type 1 diabetes mellitus or secondary diabetes mellitus or diabetes insipidus. 9. Patients with type 2 diabetes mellitus whose diabetes has not been stable and controlled for the previous three months and with HbA1c value more than or equal to 8%. 10. Patients with history of angioedema and multi-organ dysfunction. 11. Female patients who are pregnant or breast-feeding or expecting to conceive within the projected duration of the study. 12. Female patients who are of childbearing potential and who are neither surgically sterilized nor willing to use reliable contraceptive methods (like hormonal, barrier methods or intrauterine device). 13. Patients with clinically significant impaired hepatic function (SGOT & SGPT more than 3X the UNL and or Total bilirubin more than 2X the UNL) at screening. 14. Patients with clinically significant renal disorders: Estimated glomerular filtration rate: less than 30 mL per min per 1.73 m2. Serum creatinine and blood urea nitrogen (BUN) values more than or equal to 1.5 times the upper limit of normal. 15. Patients with current acute decompensated HF or hospitalization due to decompensated HF less than 4 weeks prior to enrolment. 16. Patients with MI, unstable angina, stroke or transient ischemic attack (TIA) within 12 weeks prior to randomization. 17. Patients with Coronary revascularization (percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG]) or valvular repair or replacement within 12 weeks prior to randomization or planned to undergo any of these operations after randomization. 18. Patients with implantation of a cardiac CRT within 12 weeks prior to enrolment or intent to implant a CRT device. 19. Patients with previous cardiac transplantation or implantation of a ventricular assistance device (VAD) or similar device, or implantation expected after randomization. 20. Patients with HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease. 21. Patients with symptomatic bradycardia or second or third degree heart block without a pacemaker. 22. Patients with any condition outside the CV and renal disease area, such as but not limited to malignancy, with a life expectancy of less than 2 years based on investigatorâ??s clinical judgement. 23. Pati
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| At least one class improvement in NYHA functional class from baseline to end of the study visit (Week 24).Timepoint: At Visit 1 - Screening or Baseline visit, Visit 3 - Follow up visit or Week 2 (Day 14±3), Visit 4 - Follow up visit or Week 6 (Day 42±3), Visit 5 - Follow up visit or Week 12 (Day 84±3), Visit 6 - Follow up visit or Week 18 (Day 126±3) and Visit 7 - End of the study visit or Week 24 (Day 168±3). | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean improvement in NYHA functional class from baseline to end of the study visit (Week 24).Timepoint: At Visit 1 - Screening or Baseline visit, Visit 3 - Follow up visit or Week 2 (Day 14±3), Visit 4 - Follow up visit or Week 6 (Day 42±3), Visit 5 - Follow up visit or Week 12 (Day 84±3), Visit 6 - Follow up visit or Week 18 (Day 126±3) and Visit 7 - End of the study visit or Week 24 (Day 168±3).;Mean improvement of ejection fraction (EF) from baseline to end of the study visit (Week 24).Timepoint: At Visit 1 - Screening or Baseline visit, Visit 5 - Follow up visit or Week 12 (Day 84±3) and Visit 7 - End of the study visit or Week 24 (Day 168±3).;Mean change in the potassium levels from baseline to end of the study visit (Week 24).Timepoint: At Visit 1 - Screening or Baseline visit, Visit 4 - Follow up visit or Week 6 (Day 42±3), Visit 5 - Follow up visit or Week 12 (Day 84±3), Visit 6 - Follow up visit or Week 18 (Day 126±3) and Visit 7 - End of the study visit or Week 24 (Day 168±3).;Mean change in plasma NT-pro BNP levels from baseline to end of the study visit (Week 24).Timepoint: At Visit 1 - Screening or Baseline visit, Visit 5 - Follow up visit or Week 12 (Day 84±3) and Visit 7 - End of the study visit or Week 24 (Day 168±3).;Mean changes in vital parameters (blood pressure and heart rate) from baseline to end of the study visit (Week 24).Timepoint: At Visit 1 - Screening or Baseline visit, Visit 2 - Randomization visit (Day 1), Visit 3 - Follow up visit or Week 2 (Day 14±3), Visit 4 - Follow up visit or Week 6 (Day 42±3), Visit 5 - Follow up visit or Week 12 (Day 84±3), Visit 6 - Follow up visit or Week 18 (Day 126±3) and Visit 7 - End of the study visit or Week 24 (Day 168±3).;Worsening heart failure (hospitalization or an urgent visit resulting in intravenous therapy for heart failure) from baseline to end of the study visit (Week 24). Timepoint: Throughout the study;Adverse events and Serious adverse events reported | — |
Countries
India
Contacts
Public ContactMr Mihir Upadhyay
Clinwave Research Pvt. Ltd.
Outcome results
None listed