Hyponatremia Clinical Trial
Official title:
Regional Tolvaptan Registry
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).
Purpose: A prospective, open-label, real life registry of Tolvaptan in hospitalized heart
failure patients with hyponatremia.
Hypothesis: Administration of Tolvaptan in hospitalized patients with heart failure and
hyponatremia will demonstrate improvements in patient symptom status and cost savings from
decreased healthcare utilization.
Justification: In clinical trials, Tolvaptan has been shown to quickly, effectively, and
safely improve sodium levels in heart failure patients, and decrease the length of hospital
stay and improve symptom status compared to placebo. Although Tolvaptan is an approved drug
in Canada for the treatment of patients hospitalized with heart failure and hyponatremia, its
availability is limited to private buyers and not available on hospital formularies due to
cost constraints. There are no alternatives to this first in class agent.
Objectives: The primary endpoint is reduction in length of stay for heart failure in registry
participants compared to length of stay in the Vancouver Coastal Health (VCH) administrative
data set. Secondary endpoints will include recurrent hospitalization, change in quality of
life, and B-type Natriuretic Peptide (BNP) levels over the study period.
Research Method: Patients admitted to Vancouver General Hospital (VGH) with heart failure and
hyponatremia will be identified through clinical referral by cardiologists who have ensured
that all other measures have been undertaken to improve the patient's clinical status.
Tolvaptan is dispensed according to product monograph and clinician discretion, and will be
discontinued once serum sodium is normalized, or in the case of a drug related adverse event
or hospital discharge. Bloodwork will be drawn to monitor liver function and electrolytes
during hospitalization and in follow up. Data will be captured from time of consent until 6
months after hospital discharge.
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