Postoperative Tolvaptan Use in Left Ventricular Assist Device Implantation Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Increase in Na level from the first post-operative day of hyponatremia, defined as Na < 135 mEq/L, to one-month follow-up.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •No plan for LVAD implantation
- •Age less than 18 years old
研究组 & 干预措施
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.
干预措施: tolvaptan (Drug)
结局指标
主要结局
Increase in Na level from the first post-operative day of hyponatremia, defined as Na < 135 mEq/L, to one-month follow-up.
时间窗: one month
Change in renal function, measured by estimated glomerular filtration rate (eGFR), from first post-operative day to one-month follow-up.
时间窗: one month
次要结局
未报告次要终点