Heart Assist Device, Heart Failure, Hyponatremic
Conditions
Keywords
Tolvaptan
Brief summary
This research study will compare two standard of care approaches for managing low sodium levels in heart failure patients with Left Ventricular Assist Device (LVAD). The study will compare the outcomes of LVAD patients with low sodium levels who take Tolvaptan to those who do not take Tolvaptan. Tolvaptan is FDA approved for use in the study population and is commonly used to treat low sodium levels in heart failure and LVAD patients. It is not known if taking Tolvaptan or not taking Tolvaptan is better at improving outcomes in newly implanted LVAD patients with low sodium levels. By doing this study, the Principal Investigator (PI) hopes to learn which is better at improving outcomes.
Interventions
DRUGtolvaptan
LVAD recipients with post-operative hyponatremia (Na \< 135 mEq/L). Subjects took tolvaptan 15 mg daily as part of their standard care.
Sponsors
University of Chicago
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Hospitalized patients with American College of Cardiology (ACC) and the American Heart Association (AHA) Stage D heart failure and plan to undergo LVAD implantation * Age greater than or equal to 18 years old
Exclusion criteria
* No plan for LVAD implantation * Age less than 18 years old
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Increase in Na level from the first post-operative day of hyponatremia, defined as Na < 135 mEq/L, to one-month follow-up. | one month |
| Change in renal function, measured by estimated glomerular filtration rate (eGFR), from first post-operative day to one-month follow-up. | one month |
Countries
United States
Outcome results
None listed