Postoperative Tolvaptan Use in Left Ventricular Assist Device Implantation Patients (TOLVAD)

The University of Chicago

Status: Completed

Conditions: Heart Assist Device; Hyponatremic; Heart Failure

Treatments: Drug: tolvaptan

Study type: Observational

Funder types: Other

Identifiers

NCT05408104

IRB19-0111

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

28 participants in 2 patient groups

tolvaptan (TLV)

Description:

LVAD recipients with post-operative hyponatremia (Na \< 135 mEq/L). Eligible patients took tolvaptan 15 mg daily as part of a routine care treatment plan.

Treatment:

Drug: tolvaptan

no tolvapton (no-TLV)

Description:

LVAD recipients with post-operative hyponatremia (Na \< 135 mEq/L). Eligible patients did not take tolvaptan as part of routine care.