drugset / Trial / NCT02666651
Regional Tolvaptan Registry
Non-randomizedSingle-groupOpen-labelTreatment
Summary
Low blood sodium is a common observation in patients presenting with heart failure and is associated with increased mortality, prolonged hospital stay, and repeat hospital visits. Tolvaptan is a new and approved medication to treat low sodium levels in patients who present with symptoms of heart failure, however, it is not currently available as a treatment option due to high costs not covered by our provincial plan. In this observational, non-randomized study the drug will be provided to all subjects free of charge and given only during their hospital stay. After discharge subjects will be followed for 6 months (3 visits).
Timeline
- Start
- 2016-05
- Primary completion
- 2020-01
- Completion
- 2020-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tolvaptan | Small molecule | 15 mg | Oral |
| Subject | Tolvaptan | Small molecule | 60 mg | Oral |