NCT05408104

Postoperative Tolvaptan Use in Left Ventricular Assist Device Implantation Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 28 (actual)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Heart Failure
• Heart Assist Device
• Hyponatremic

Interventions

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

Timeline

• Start date: 2019-03-28
• Primary completion: 2022-05-01
• Completion: 2022-05-01
• First posted: 2022-06-07
• Last updated: 2022-06-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study