Hyponatremia Clinical Trial
— TolvaptanOfficial title:
Regional Tolvaptan Registry
NCT number | NCT02666651 |
Other study ID # | H15-00115 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | May 2016 |
Est. completion date | January 2020 |
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).
Status | Recruiting |
Enrollment | 25 |
Est. completion date | January 2020 |
Est. primary completion date | January 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility |
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.) |
Country | Name | City | State |
---|---|---|---|
Canada | Vancouver General Hospital | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
Cardiology Research UBC |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hospital length of stay | Hospital length of stay for heart failure in the treatment group will be measured as days and compared to administrative regional data describing patient outcomes from the local health authority. | Subjects are followed for 6 months after discharge | |
Secondary | Recurrent hospitalization. | This will be measured by the number of times a patient is readmitted to hospital following their discharge from the initial hospitalization. | Subjects are followed for 6 months after discharge | |
Secondary | Change in quality of life. | This will be assessed by administrating the Minnesota Living with Heart Failure questionnaire at initial hospitalization, 1 month follow-up, 3 month follow-up, and 6 month follow-up timepoints. | Subjects are followed for 6 months after discharge | |
Secondary | BNP (Brain-Type Natriuretic Peptide) levels | BNP is an established biomarker of CHF severity and blood samples will be collected at 1, 3, and 6 month visits. Values will be collected as a continuous variable. | Subjects are followed for 6 months after discharge |
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