Postoperative Tolvaptan Use in Left Ventricular Assist Device Implantation Patients

Completed

• Conditions: Heart Assist Device; Heart Failure; Hyponatremic
• Interventions: Drug: tolvaptan

• Registration Number: NCT05408104
• Lead Sponsor: University of Chicago

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-28
• Primary Completion: 2022-05-01
• Study Completion: 2022-05-01
• Study First Submitted: 2022-05-24
• Status Verified: 2022-06
• Study First Submitted QC: 2022-06-03
• Last Update Submitted: 2022-06-03
• Study First Posted: 2022-06-07
• Last Update Posted: 2022-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
tolvaptan (TLV)	tolvaptan	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States