Comparison of effectiveness of once daily dose of Torsemide Extended Release to two times daily dose of Furosemide on excretion of sodium in the urine and body weight in Congestive Heart Failure patients who are on stable dose of Furosemide.

Phase 2

• Conditions: Health Condition 1: I509- Heart failure, unspecified

• Registration Number: CTRI/2019/01/016988
• Lead Sponsor: Sarfez Pharmaceuticals Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified