Recruiting

Tolvaptan

Sponsor:

Cardiology Research UBC

Code:

NCT02666651

Conditions

Decompensated Heart Failure

Hyponatremia

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Tolvaptan

No intervention

Study Details

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).

Conditions

Decompensated Heart Failure

Hyponatremia

Study ID

NCT02666651

Start date

May, 2016

Status verified date

Aug, 2018

Completion date

Jan, 2020

Anticipated

Primary completion date

Jan, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

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.)

Study Design

Enrollment

25 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Test group

Administration of oral tolvaptan (15-60mg PO titration) during admission for decompensated heart failure

other: Control group

There is no intervention planned for the Control group. Aggregate administrative regional data describing patient outcomes from the local health authority

Interventions

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.

Primary outcome measure

  • Hospital length of stay [ Time Frame: Subjects are followed for 6 months after discharge ]

Central Contacts and Locations

Central contacts

Andrew Starovoytov, MD, CCRP

604-875-5079a.starovoytov@ubc.ca

Melissa Bedford, BSc

604-875-5120melissa.bedford@vch.ca

Locations

Vancouver General Hospital

Recruiting

Vancouver, British Columbia, Canada, V5Z 1M9

Contacts

Andrew Starovoytov, MD, CCRP

604-875-5079a.starovoytov@ubc.ca

Melissa Bedford, BSc

604-875-5120melissa.bedford@vch.ca

Principal Investigator:

Sean Virani, MD, MSc, MPH, FRCPC

More Information

Sponsor

Cardiology Research UBC

Last update posted

Aug 10, 2018

Last verified

Aug, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Cardiology Research UBC on 2018-08-10.