Regional Tolvaptan Registry

• Status: Unknown status
• Trial end date: 2020-01-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cardiology Research UBC
• Treatments: Tolvaptan

Criteria

Inclusion Criteria:

1. Patient has clinical evidence of heart failure AND elevated BNP or evidence of left ventricular dysfunction (left ventricular ejection fraction (LVEF) < 40%) on diagnostic imaging.

2. Serum sodium < 130 mmol/L OR serum sodium 131-134 mmol/L and symptomatic.

3. Sodium and fluid restriction ongoing.

4. Trial of optimal diuretic therapy (at prescribing physician's clinical discretion).

5. Discontinuation of non-essential medications/treatments that are known to cause hyponatremia.

Exclusion Criteria:

1. Life expectancy < 6 months

2. Documented adverse events with tolvaptan in the past

3. Meet exclusion criteria from the Study of Ascending Levels of Tolvaptan in Hyponatremia (SALT Trial):

• Serum sodium < 120mmol/L if neurologic impairment

• Confounding disease (e.g. recent stroke or myocardial infarction (MI), recent surgery, uncontrolled diabetes, etc.)