Institute for Stroke and Dementia Research, University Hospital, LMU Munich, Munich, Germany.
Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.
Eur Stroke J. 2023 Mar;8(1):387-397. doi: 10.1177/23969873221143570. Epub 2022 Dec 16.
Hypertension is the leading modifiable risk factor for cerebral small vessel diseases (SVDs). Yet, it is unknown whether antihypertensive drug classes differentially affect microvascular function in SVDs.
To test whether amlodipine has a beneficial effect on microvascular function when compared to either losartan or atenolol, and whether losartan has a beneficial effect when compared to atenolol in patients with symptomatic SVDs.
TREAT-SVDs is an investigator-led, prospective, open-label, randomised crossover trial with blinded endpoint assessment (PROBE design) conducted at five study sites across Europe. Patients aged 18 years or older with symptomatic SVD who have an indication for antihypertensive treatment and are suffering from either sporadic SVD and a history of lacunar stroke or vascular cognitive impairment (group A) or CADASIL (group B) are randomly allocated 1:1:1 to one of three sequences of antihypertensive treatment. Patients stop their regular antihypertensive medication for a 2-week run-in period followed by 4-week periods of monotherapy with amlodipine, losartan and atenolol in random order as open-label medication in standard dose.
The primary outcome measure is cerebrovascular reactivity (CVR) as determined by blood oxygen level dependent brain MRI signal response to hypercapnic challenge with change in CVR in normal appearing white matter as primary endpoint. Secondary outcome measures are mean systolic blood pressure (BP) and BP variability (BPv).
TREAT-SVDs will provide insights into the effects of different antihypertensive drugs on CVR, BP, and BPv in patients with symptomatic sporadic and hereditary SVDs.
European Union's Horizon 2020 programme.
NCT03082014.
高血压是脑小血管病（SVD）的主要可改变危险因素。然而，目前尚不清楚降压药类别是否会对 SVD 中的微血管功能产生不同影响。
比较氨氯地平与氯沙坦或阿替洛尔相比，以及氯沙坦与阿替洛尔相比，在有症状性 SVD 患者中对微血管功能是否具有有益作用。
TREAT-SVD 是一项由研究者主导、前瞻性、开放标签、随机交叉试验，终点评估为盲法（PROBE 设计），在欧洲五个研究地点进行。年龄在 18 岁或以上、有症状性 SVD、有降压治疗指征、患有散发性 SVD 和腔隙性卒中史或血管性认知障碍（A 组）或 CADASIL（B 组）的患者，按 1:1:1 随机分配至三种降压治疗方案之一。患者停用常规降压药物进行 2 周的洗脱期，随后进行 4 周的单药治疗，氨氯地平、氯沙坦和阿替洛尔以开放标签药物的标准剂量随机顺序给药。
主要结局测量指标是通过血氧水平依赖脑 MRI 信号对高碳酸血症挑战的反应来确定的脑血管反应性（CVR），以正常表现的白质中 CVR 的变化为主要终点。次要结局测量指标是平均收缩压（BP）和 BP 变异性（BPv）。
TREAT-SVD 将提供关于不同降压药物对有症状性散发性和遗传性 SVD 患者的 CVR、BP 和 BPv 影响的见解。
欧盟地平线 2020 计划。
NCT03082014。
