Health Condition 1: I509- Heart failure, unspecified
Conditions
Interventions
Intervention1: Torsemide ER 20 mg/40 mg: Torsemide ER tablets 20 mg/40 mg once-daily dose, Total duration of the study will be of approximately 61 days from the day of enrolment in the study. Addition
Sponsors
Sarfez Pharmaceuticals Inc
Ms Syngene International Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients of either gender above 18 years with clinical diagnosis of CHF 2.Patients with NYHA functional class II 3.On a stable twice daily dose of furosemide 20 mg/40 mg or twice daily dose of furosemide 20 mg/40 mg and once daily dose of spironolactone 25 mg or twice daily dose of furosemide 20 mg/40 mg and once daily dose of eplerenone 25 mg for two weeks 4.eGFR >30 ml/min/1.73 m.sq 5.Serum NT-proBNP >1600 pg/ml 6.Presence of pitting edema of grade 1+ or more 7.Premenopausal women of child-bearing potential have a negative pregnancy test prior to beginning of the study and agree to use effective contraceptive methods during the study period.
Exclusion criteria
Exclusion criteria: 1. Age below 18 or above 70 years 2. Requirement for a diuretic other than furosemide, spironolactone and eplerenone. 3. Estimated glomerular filtration rate (eGFR) equal to or below 30 ml/min/1.73 m.sq 4. Requirement for a non-steroidal anti-inflammatory drug(NSAID), cyclooxygenase-2 inhibitor (e.g. Celecoxib) or Allopurinol.If receiving such agents, patients may be switched to acetaminophen if agreed by the investigator and dosing is maintained throughout the study. 5. Allergy to diuretics or sulphonamide-derived compounds. 6. Sitting systolic blood pressure (SBP) at or below 100 mm Hg or at or above 180 mm Hg. 7. History of cardiac dysrhythmia (including atrial fibrillation). 8. Serum potassium concentration (K+) equal to or below 3.5 mEq/L (mmol/L) 9. Other concurrent cardiovascular illness (except diabetes) requiring treatment 10. Body mass index (BMI) equal to or greater than 35 Kg/m.sq 11. History of myocardial infarction or stroke within the preceding 3 months 12. More than 1+ proteinuria on urinalysis (UA) 13. Patients requiring change in the concomitant medication dosages. 14. Inability to comprehend or comply with the informed consent (including a physicianââ?¬•s assessment of prior drug non-compliance) 15. Patients who are incontinent of urine or faeces, or cannot empty their bladder completely. 16. Patients who have participated in another clinical study in the past 3 months prior to commencement of this study. 17. Female patients who are breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the effectiveness of 20 mg/40 mg once-daily dose of Torsemide ER to 20 mg/40 mg twice-daily dose of Furosemide on 24-hour sodium excretion.Timepoint: Change in 24-hour sodium excretion compared to baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To compare the effects of 20 mg/40 mg once-daily dose of Torsemide ER to 20 mg/40 mg twice-daily dose of furosemide on changes in body weight after two weeks of treatment. 2.To compare the frequency and volume of urine passed in 24 hours. 3.To compare the effects of 20 mg/40 mg once-daily dose of Torsemide ER to 20 mg/40 mg twice-daily dose of furosemide on the levels of Serum NT-proBNP (N-terminal pro b-type natriuretic peptide) after two weeks of treatment.Timepoint: 1.Change in body weight compared to baseline after two weeks of treatment. 2.Assess frequency and volume of urine passed in 24 hours. 3.Change in serum NT-proBNP from baseline after two weeks of treatment | — |
Countries
India
Contacts
Public ContactDr Anand Eswaraiah M D
Syngene International Limited, Clinical Development
Outcome results
None listed