TOLVAD: Postoperative Tolvaptan Use in Left Ventricular Assist Device Implantation Patients

• Sponsor: University of Chicago (Other)
• Overall Status: Completed
• CT.gov ID: NCT05408104
• Collaborator: (none)
• Enrollment: 28
• Location: 1
• Actual Duration (Months): 37.1
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure; Heart Assist Device; Hyponatremic	Drug: tolvaptan

Study Design

• Study Type: Observational
• Actual Enrollment: 28 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Postoperative Tolvaptan Use in Left Ventricular Assist Device Implantation Patients
• Actual Study Start Date: Mar 28, 2019
• Actual Primary Completion Date: May 1, 2022
• Actual Study Completion Date: May 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
tolvaptan (TLV) 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.	Drug: tolvaptan; LVAD recipients with post-operative hyponatremia (Na < 135 mEq/L). Subjects took tolvaptan 15 mg daily as part of their standard care.
no tolvapton (no-TLV) LVAD recipients with post-operative hyponatremia (Na < 135 mEq/L). Eligible patients did not take tolvaptan as part of routine care.

Outcome Measures

Primary Outcome Measures

1. 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]

2. Change in renal function, measured by estimated glomerular filtration rate (eGFR), from first post-operative day to one-month follow-up. [one month]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Chicago Medical Center	Chicago	Illinois	United States	60637

Sponsors and Collaborators

• University of Chicago

Investigators

• Principal Investigator: Gene Kim, MD, University of Chicago

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Chicago
• ClinicalTrials.gov Identifier: NCT05408104
• Other Study ID Numbers: IRB19-0111
• First Posted: Jun 7, 2022
• Last Update Posted: Jun 7, 2022
• Last Verified: Jun 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Chicago: Tolvaptan
• Additional relevant MeSH terms: Heart Failure; Tolvaptan

Study Results

No Results Posted as of Jun 7, 2022