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

June 3, 2022 updated by: University of Chicago
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

28

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University Of Chicago Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study will include patients at University of Chicago Medical Center (UCMC) being followed by the advanced heart failure group that are planned to undergo LVAD implantation.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Increase in Na level from the first post-operative day of hyponatremia, defined as Na < 135 mEq/L, to one-month follow-up.
Time Frame: one month
one month
Change in renal function, measured by estimated glomerular filtration rate (eGFR), from first post-operative day to one-month follow-up.
Time Frame: one month
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2019

Primary Completion (Actual)

May 1, 2022

Study Completion (Actual)

May 1, 2022

Study Registration Dates

First Submitted

May 24, 2022

First Submitted That Met QC Criteria

June 3, 2022

First Posted (Actual)

June 7, 2022

Study Record Updates

Last Update Posted (Actual)

June 7, 2022

Last Update Submitted That Met QC Criteria

June 3, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB19-0111

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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