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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06037928 -
Plasma Sodium and Sodium Administration in the ICU
|
||
Recruiting |
NCT04561531 -
Efficacy and Safety of Bolus Comparing With Continuous Drip of 3% NaCl in Patients With Severe Symptomatic Hyponatremia.
|
N/A | |
Terminated |
NCT02012959 -
Study of the Safety and Effectiveness of SAMSCA® (Tolvaptan) in Children and Adolescents With Euvolemic or Hypervolemic Hyponatremia
|
Phase 3 | |
Recruiting |
NCT02936167 -
Comparison of Ringer Lactate and Isotonic Acetate Solution as Perioperative Maintenance Fluid for Children
|
N/A | |
Completed |
NCT00621348 -
Maintenance Intravenous Fluids in Children
|
Phase 3 | |
Terminated |
NCT03703713 -
Colloid Osmotic Pressure and Osmolality in Hyponatremia
|
||
Completed |
NCT02926989 -
Intravenous Fluids in Hospitalised Children
|
Phase 4 | |
Terminated |
NCT02959411 -
Tolvaptan for Advanced or Refractory Heart Failure
|
Phase 4 | |
Completed |
NCT02573077 -
An Observational Study Measuring Outcomes in Cancer Patients Treated for Moderate to Severe Hyponatremia in Italy
|
||
Withdrawn |
NCT02667977 -
Reexamining Hypotonic Intravenous Fluid Use
|
N/A | |
Terminated |
NCT01708811 -
Hyponatremia and Myometrium Contractility. An Invitro Study
|
N/A | |
Completed |
NCT01456533 -
Copeptin in the Differential Diagnosis of Dysnatremia in Hospitalized Patients
|
N/A | |
Withdrawn |
NCT01326429 -
Frequency and Origin of Dysnatremias in the Emergency Department
|
N/A | |
Terminated |
NCT01227512 -
Effects of Tolvaptan vs Fluid Restriction in Hospitalized Subjects With Dilutional Hyponatremia
|
Phase 3 | |
Recruiting |
NCT06013800 -
Hyponatremia Volume Status Analysis by Point-of-care Ultrasound
|
||
Terminated |
NCT04020926 -
Impact of Hyponatremia on Muscle Strength, Gait and Cognitive Function
|
||
Withdrawn |
NCT02442674 -
A Trial of Tolvaptan in Children and Adolescent Subjects With Euvolemic and Hypervolemic Hyponatremia
|
Phase 3 | |
Completed |
NCT02545101 -
An Observational Study on Real-world Use and Outcomes of Patients Treated With Tolvaptan for Hyponatraemia Due to SIADH
|
N/A | |
Terminated |
NCT02215148 -
Pharmacokinetics and Clinical Response of Tolvaptan in Neurocritical Care Patients
|
N/A | |
Recruiting |
NCT01748331 -
The Effect of Fluid Restriction in Congestive Heart Failure Complicated With Hyponatremia
|
N/A |