A Crossover Study of Patients With HF to Compare Natriuretic Effects of IR Torsemide vs. ER Torsemide Over 12 Hrs
NCT06708611 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL
Last updated 2026-04-27
Summary
This is a randomized double-blind crossover study of the patients with stable heart failure, who are taking a loop diuretic. During the study period, the participants' loop diuretics will be replaced by the equivalent dose of immediate release/extended release torsemide for one week. After a one week period, they will report to the site and will receive a single dose of either immediate release or extended release Torsemide. The sodium excretion will be measured for six hours after dosing and for an additional six hours after a high salt lunch.
Conditions
Interventions
- DRUG
-
torsemide
Extended release formulation of torsemide
Sponsors & Collaborators
-
Sarfez Pharmaceuticals, Inc.
lead INDUSTRY
Principal Investigators
-
Sophia Shah, MD · Safez Pharmaceuticals
-
Nayle A Ancares, MD · Future Life Clinical Trials
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-01-15
- Primary Completion
- 2025-03-25
- Completion
- 2025-03-25
- FDA Drug
- Yes
Countries
- United States
Study Locations
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