Postoperative Tolvaptan Use in Left Ventricular Assist Device Implantation Patients

NCT05408104 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 28

Last updated 2022-06-07

No results posted yet for this study

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.

Conditions

Interventions

DRUG

tolvaptan

LVAD recipients with post-operative hyponatremia (Na \< 135 mEq/L). Subjects took tolvaptan 15 mg daily as part of their standard care.

Sponsors & Collaborators

  • University of Chicago

    lead OTHER

Principal Investigators

  • Gene Kim, MD · University of Chicago

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-28
Primary Completion
2022-05-01
Completion
2022-05-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05408104 on ClinicalTrials.gov