Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
25 participants
INTERVENTIONAL
2016-05-31
2020-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Test group
Administration of oral tolvaptan (15-60mg PO titration) during admission for decompensated heart failure
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.
Control group
There is no intervention planned for the Control group. Aggregate administrative regional data describing patient outcomes from the local health authority
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
2. Documented adverse events with tolvaptan in the past
* Serum sodium \< 120mmol/L if neurologic impairment
* Confounding disease (e.g. recent stroke or myocardial infarction (MI), recent surgery, uncontrolled diabetes, etc.)
19 Years
ALL
No
Sponsors
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Cardiology Research UBC
OTHER
Responsible Party
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Principal Investigators
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Sean Virani, MD, MSc, MPH, FRCPC
Role: PRINCIPAL_INVESTIGATOR
Director of the Heart Failure and Cardiology-Oncology Programs at VGH
Locations
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Vancouver General Hospital
Vancouver, British Columbia, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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H15-00115
Identifier Type: -
Identifier Source: org_study_id
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