Postoperative Tolvaptan Use in Left Ventricular Assist Device Implantation Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

28 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-28

Study Completion Date

2022-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Tolvaptan to Reduce Length of Stay in Hospitalized Patients With Cirrhosis and Hyponatremia

NCT01890694

Hyponatremia

TERMINATED PHASE4

Tolvaptan for In-hospital Hyponatremia

NCT01386372

Hyponatremia

TERMINATED PHASE2

Effects of Tolvaptan vs Fluid Restriction in Hospitalized Subjects With Dilutional Hyponatremia

NCT01227512

Hyponatremia Dilutional Hyponatremia Inappropriate ADH Syndrome

TERMINATED PHASE3

Natriuresis-guided Depletion After Cardiac Surgery

NCT07077772

Cardiac Surgery Diuresis Congestion, Venous +2 more

RECRUITING NA

The Effect of Fluid Restriction in Congestive Heart Failure Complicated With Hyponatremia

NCT01748331

Heart Failure Hyponatremia

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Failure Heart Assist Device Hyponatremic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

tolvaptan

Intervention Type DRUG

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.

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

tolvaptan

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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