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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date August 2018
Source Cardiology Research UBC
Contact Andrew Starovoytov, MD, CCRP
Phone 604-875-5079
Email a.starovoytov@ubc.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Tolvaptan
Tolvaptan is dispensed during hospitalization according to its product monograph and clinician discretion. It will be discontinued once serum sodium is normalized, or in the case of a drug related adverse event or hospital discharge.
Other:
No intervention
There is no intervention planned for the Control group. Aggregate administrative regional data describing patient outcomes from the local health authority will be used as a comparator.

Locations

Country Name City State
Canada Vancouver General Hospital Vancouver British Columbia

Sponsors (1)

Lead Sponsor Collaborator
Cardiology Research UBC

Country where clinical trial is conducted

Canada, 

Outcome

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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