Postoperative Tolvaptan Use in Left Ventricular Assist Device Implantation Patients

Heart Failure Clinical Trial

— TOLVAD  

Official title:

Postoperative Tolvaptan Use in Left Ventricular Assist Device Implantation Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05408104
• Other study ID #: IRB19-0111
• Status: Completed
• Start date: March 28, 2019
• Est. completion date: May 1, 2022

Study information

• Verified date: June 2022
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: May 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Assist Device
• Heart Failure
• Hyponatremic

Intervention

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

Locations

Country	Name	City	State
United States	University of Chicago Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change in renal function, measured by estimated glomerular filtration rate (eGFR), from first post-operative day to one-month follow-up.		one month