Cardiology and Syncope Unit, Department of Translational Medical Sciences, University of Campania 'Luigi Vanvitelli'-Monaldi Hospital, Piazzale E. Ruggeri, 80126 Naples, Italy.
Division of Cardiology, Ospedale Generale Regionale, Via Lorenz Böhler 5, 39100 Bolzano, Italy.
Eur Heart J. 2023 Jul 14;44(27):2473-2479. doi: 10.1093/eurheartj/ehad322.
The traditional nitroglycerin (NTG) head-up tilt test (HUTT) is time-consuming and the test duration is a barrier to widespread utilization in clinical practice. It was hypothesized that a short-duration protocol is not inferior to the traditional protocol regarding the positivity rate and has a similar distribution of hemodynamic response.
Patients undergoing HUTT were randomized 1:1 to a 10 min passive phase plus a 10 min 0.3 mg NTG if the passive phase was negative (Fast) or to a 20 min passive phase plus a 15 min 0.3 mg NTG if the passive phase was negative (Traditional). A sample size of 277 patients for each group achieved 80% power to detect an expected difference of 0% with a non-inferiority margin of -10% using a one-sided t-test and assuming a significant level alpha of 0.025. A total of 554 consecutive patients (mean age 46.6 ± 19.3 years, 47.6% males) undergoing HUTT for suspected vasovagal syncope were randomly assigned to the Fast (n = 277) or Traditional (n = 277) protocol. A positive response was defined as the induction of syncope in presence of hypotension/bradycardia, and was observed in 167 (60.3%) patients with Fast and in 162 (58.5%) patients with the Traditional protocol. There was a trend of lesser vasodepressor response (14.8% Fast vs. 20.6% Traditional) which was significant during the passive phase (P = 0.01).
The diagnostic value of the Fast HUTT protocol is similar to that of the Traditional protocol and therefore the Fast protocol can be used instead of the Traditional protocol.
传统的硝酸甘油(NTG)头高位倾斜试验(HUTT)耗时较长,试验持续时间是其在临床实践中广泛应用的障碍。研究假设短时间方案在阳性率方面不劣于传统方案,并且具有相似的血液动力学反应分布。
接受 HUTT 的患者按 1:1 随机分为 10 分钟被动期加阴性时(阴性)的 10 分钟 0.3mgNTG(快速)或 20 分钟被动期加阴性时(阴性)的 15 分钟 0.3mgNTG(传统)。每组 277 例患者的样本量达到 80%的效力,使用单侧 t 检验检测预期差异为 0%,非劣效性边界为-10%,假设显著水平 alpha 为 0.025。共 554 例连续疑似血管迷走性晕厥患者接受 HUTT,随机分为快速(n = 277)或传统(n = 277)方案。阳性反应定义为低血压/心动过缓时诱导晕厥,并在快速组的 167 例(60.3%)患者和传统组的 162 例(58.5%)患者中观察到。在被动期,快速组的血管舒张反应较低(14.8%快速 vs. 20.6%传统),有趋势(P = 0.01)。
快速 HUTT 方案的诊断价值与传统方案相似,因此可以代替传统方案。