NCT02666651

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2016

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 28, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

August 10, 2018

Status Verified

August 1, 2018

Enrollment Period

3.7 years

First QC Date

January 14, 2016

Last Update Submit

August 8, 2018

Conditions

Decompensated Heart FailureHyponatremia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Recurrent hospitalization.

    Subjects are followed for 6 months after discharge

  • Change in quality of life.

    Subjects are followed for 6 months after discharge

  • BNP (Brain-Type Natriuretic Peptide) levels

    Subjects are followed for 6 months after discharge

Study Arms (2)

Test group

EXPERIMENTAL

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

Drug: Tolvaptan

Control group

OTHER

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

Other: No intervention

Interventions

TolvaptanDRUG

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.

Also known as: Samsca
Test group
No interventionOTHER

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.

Control group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Serum sodium \< 130 mmol/L OR serum sodium 131-134 mmol/L and symptomatic.
  • Sodium and fluid restriction ongoing.
  • Trial of optimal diuretic therapy (at prescribing physician's clinical discretion).
  • Discontinuation of non-essential medications/treatments that are known to cause hyponatremia.

You may not qualify if:

  • Life expectancy \< 6 months
  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

RECRUITING

MeSH Terms

Conditions

Hyponatremia

Interventions

Tolvaptan

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

BenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Sean Virani, MD, MSc, MPH, FRCPC

    Director of the Heart Failure and Cardiology-Oncology Programs at VGH

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew Starovoytov, MD, CCRP

CONTACT

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

Melissa Bedford, BSc

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2016

First Posted

January 28, 2016

Study Start

May 1, 2016

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

August 10, 2018

Record last verified: 2018-08

Locations

CA(1)