Postoperative Tolvaptan Use in Left Ventricular Assist Device Implantation Patients

NCT05408104 | Completed FDA Drug

• 1 other identifier: IRB19-0111
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Heart Assist Device; Hyponatremic

Keywords

Tolvaptan

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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

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.

Interventions

tolvaptan DRUG

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

tolvaptan (TLV)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• No plan for LVAD implantation
• Age less than 18 years old

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Tolvaptan

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Gene Kim, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2022
• First Posted: June 7, 2022
• Study Start: March 28, 2019
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: June 7, 2022

Record last verified: 2022-06

Locations

US (1)