Belkin Mark N, Imamura Teruhiko, Rodgers Daniel, Kanelidis Anthony J, Henry Michael P, Fujino Takeo, Kagan Viktoriya, Meehan Karen, Okray Justin, Creighton Shana, LaBuhn Colleen, Song Tae, Ota Takeyoshi, Jeevanandam Valluvan, Nguyen Ann B, Chung Ben B, Smith Bryan A, Kalantari Sara, Grinstein Jonathan, Sarswat Nitasha, Pinney Sean P, Sayer Gabriel, Kim Gene, Uriel Nir
Cardiology, UChicago Medicine, Chicago, Illinois, USA.
Second Department of Internal Medicine, University of Toyama, Toyama, Japan.
Artif Organs. 2022 Dec;46(12):2382-2390. doi: 10.1111/aor.14375. Epub 2022 Sep 15.
Tolvaptan, a selective vasopressin type-2 antagonist, has been shown to increase serum sodium (Na) and urine output in hyponatremic left ventricular assist device (LVAD) patients in retrospective studies. In this prospective randomized pilot study, we aimed to assess the efficacy of tolvaptan in this population.
We conducted a prospective, randomized, non-blinded pilot study of LVAD recipients with post-operative hyponatremia (Na < 135 mEq/L) (NCT05408104). Eligible participants were randomized to receive tolvaptan 15 mg daily in addition to usual care versus usual care alone. The primary outcome was a change in Na level and estimated glomerular filtration rate (eGFR), from the first post-operative day of hyponatremia (the day of randomization) to discharge.
A total of 33 participants were enrolled, and 28 underwent randomization (median age 55 [IQR 50-62]), 21% women, 54% Black, 32% ischemic cardiomyopathy, median baseline Na 135 (IQR 134-138). Fifteen participants were randomized to tolvaptan (TLV) and 13 were randomized to usual care alone (No-TLV). Mean change in Na from randomization to discharge in the TLV group was 2.7 mEq/L (95%CI 0.7-4.7, p = 0.013) and 1.8 (95%CI 0.5-4.0, p = 0.11) in the No-TLV group, though baseline and final Na levels were similar between groups. The mean change in eGFR was 2.6 ml/min/1.73 m (95%CI 10.1-15.3, p = 0.59) in TLV versus 7.5 ml/min/1.73 m (95%CI 5.2-20.2, p = 0.15) in No-TLV. TLV participants had significantly more urine output than No-TLV patients during their first 24 h after randomization (3294 vs 2155 ml, p = 0.043).
TLV significantly increases urine output, with nominal improvement in Na level, in hyponatremic post-operative LVAD patients without adversely impacting renal function.
在回顾性研究中，托伐普坦（一种选择性血管加压素2型拮抗剂）已被证明可提高低钠血症左心室辅助装置（LVAD）患者的血清钠（Na）水平并增加尿量。在这项前瞻性随机试验研究中，我们旨在评估托伐普坦在该人群中的疗效。
我们对术后低钠血症（Na＜135 mEq/L）的LVAD接受者进行了一项前瞻性、随机、非盲试验研究（NCT05408104）。符合条件的参与者被随机分配接受除常规护理外每日15毫克托伐普坦治疗或仅接受常规护理。主要结局是从低钠血症术后第一天（随机分组日）到出院时Na水平和估计肾小球滤过率（eGFR）的变化。
共招募了33名参与者，28名接受了随机分组（中位年龄55岁[四分位间距50 - 62岁]），21%为女性，54%为黑人，32%为缺血性心肌病，中位基线Na为135（四分位间距134 - 138）。15名参与者被随机分配到托伐普坦组（TLV），13名被随机分配到仅接受常规护理组（非TLV）。TLV组从随机分组到出院时Na的平均变化为2.7 mEq/L（95%置信区间0.7 - 4.7，p = 0.013），非TLV组为1.8（95%置信区间0.5 - 4.0，p = 0.11），尽管两组的基线和最终Na水平相似。TLV组eGFR的平均变化为2.6 ml/min/1.73 m²（95%置信区间 - 10.1 - 15.3，p = 0.59），非TLV组为7.5 ml/min/1.73 m²（95%置信区间5.2 - 20.2，p = 0.15）。TLV组参与者在随机分组后的头24小时内尿量明显多于非TLV组患者（3294对2155毫升，p = 0.043）。
在术后低钠血症的LVAD患者中，托伐普坦显著增加尿量，Na水平有一定改善，且对肾功能无不良影响。
