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Completed

NCT Number: NCT05408104

Postoperative Tolvaptan Use in Left Ventricular Assist Device Implantation Patients

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Assist Device Heart Diseases Hyponatremic

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tolvaptan

Drug

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

Primary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Acronym: TOLVAD

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jun 7, 2022
Registry last updated
Jun 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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