Ignite Creation Date:
2024-05-06 @ 8:05 AM
Last Modification Date:
2024-10-26 @ 11:56 AM
Study NCT ID:
NCT02666651
Status:
UNKNOWN
Last Update Posted:
2018-08-10
First Post:
2016-01-14
Brief Title:
Regional Tolvaptan Registry
Sponsor:
Cardiology Research UBC
Organization:
Cardiology Research UBC
Study Overview
Official Title:
Regional Tolvaptan Registry
Status:
UNKNOWN
Status Verified Date:
2018-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Tolvaptan
Brief 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
Detailed Description:
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 patients 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
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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None