■隐性高血压与靶器官损害(TOD)和不良健康结局有关,但抗高血压治疗是否能改善隐性高血压患者的TOD尚待证实.
■在这个多中心,随机化,双盲,在15家中国医院进行的安慰剂对照试验,未经治疗的门诊患者年龄30-70岁,办公室血压(BP)<140/<90mmHg和24小时,纳入日间或夜间动态血压≥130/≥80,≥135/≥85或≥120/≥70mmHg.患者有≥1个TOD征象:心电图左心室肥厚(LVH),臂踝脉搏波传导速度(baPWV)≥1400cm/s,或尿白蛋白/肌酐比值(ACR)≥3.5mg/mmol女性和≥2.5mg/mmol男性。排除标准包括继发性高血压,糖尿病肾病,血清肌酐≥176.8μmol/L,和6个月内的心血管疾病筛查。在对中心进行分层后,性和夜间高血压的存在,符合条件的患者被随机分配(1:1)接受抗高血压治疗或安慰剂治疗.患者和研究者被掩盖成组分配。主动治疗包括从80毫克/天开始的阿利沙坦,在第2个月时增加至160mg/天,如果动态血压仍然不受控制,则在第4个月时与氨氯地平联合2.5mg/天。在对照组中同样使用匹配的安慰剂。主要终点是TOD的改善,定义为baPWV的归一化,在48周的随访中,ACR或LVH或baPWV或ACR降低≥20%。意向治疗分析包括所有随机分组的患者,完全遵守协议的符合协议分析患者,和安全性分析所有接受至少一剂研究药物的患者。这项研究在ClinicalTrials.gov注册,NCT02893358。
■在2017年2月14日至2020年10月31日之间,招募了320名患者(43.1%的女性;平均年龄±SD53.7±9.7岁)。基线办公室和24小时血压平均为130±6.0/81±5.9mmHg和136±8.6/84±6.1mmHg,以及baPWV升高的患病率,ACR和LVH为97.5%,12.5%,和7.8%,分别。在积极治疗的153例患者中,24小时BP平均(±SE)降低了10.1±0.9/6.4±0.5mmHg,在安慰剂的167例患者中,24小时BP平均降低了1.3±0.9/1.0±0.5mmHg。79例随机接受积极治疗的患者和49例接受安慰剂治疗的患者TOD改善:51.6%(95%CI43.7%,59.5%)与29.3%(22.1,36.5%;p<0.0001)。按方案和亚组分析是确证的。不良事件一般是轻微的,发生在38(25.3%)和43(26.4%)随机接受积极治疗和安慰剂的患者。分别(p=0.83)。
■我们的结果表明,抗高血压治疗可改善隐性高血压患者的TOD,强调治疗的必要性。然而,预防心血管并发症的长期获益仍有待确定.
■Salubris中国。
UNASSIGNED: Masked hypertension is associated with target organ damage (TOD) and adverse health outcomes, but whether antihypertensive treatment improves TOD in patients with masked hypertension is unproven.
UNASSIGNED: In this multicentre, randomised, double-blind, placebo-controlled
trial at 15 Chinese hospitals, untreated outpatients aged 30-70 years with an office blood pressure (BP) of <140/<90 mm Hg and 24-h, daytime or nighttime ambulatory BP of ≥130/≥80, ≥135/≥85, or ≥120/≥70 mm Hg were enrolled. Patients had ≥1 sign of TOD: electrocardiographic left ventricular hypertrophy (LVH), brachial-ankle pulse wave velocity (baPWV) ≥1400 cm/s, or urinary albumin-to-creatinine ratio (ACR) ≥3.5 mg/mmol in women and ≥2.5 mg/mmol in men. Exclusion criteria included secondary hypertension, diabetic nephropathy, serum creatinine ≥176.8 μmol/L, and cardiovascular disease within 6 months of screening. After stratification for centre, sex and the presence of nighttime hypertension, eligible patients were randomly assigned (1:1) to receive antihypertensive treatment or placebo. Patients and investigators were masked to group assignment. Active treatment consisted of allisartan starting at 80 mg/day, to be increased to 160 mg/day at month 2, and to be combined with amlodipine 2.5 mg/day at month 4, if the ambulatory BP remained uncontrolled. Matching placebos were used likewise in the control group. The primary endpoint was the improvement of TOD, defined as normalisation of baPWV, ACR or LVH or a ≥20% reduction in baPWV or ACR over the 48-week follow-up. The intention-to-treat analysis included all randomised patients, the per-protocol analysis patients who fully adhered to the protocol, and the safety analysis all patients who received at least one dose of the
study medication. This
study is registered with ClinicalTrials.gov, NCT02893358.
UNASSIGNED: Between February 14, 2017, and October 31, 2020, 320 patients (43.1% women; mean age ± SD 53.7 ± 9.7 years) were enrolled. Baseline office and 24-h BP averaged 130 ± 6.0/81 ± 5.9 mm Hg and 136 ± 8.6/84 ± 6.1 mm Hg, and the prevalence of elevated baPWV, ACR and LVH were 97.5%, 12.5%, and 7.8%, respectively. The 24-h BP decreased on average (±SE) by 10.1 ± 0.9/6.4 ± 0.5 mm Hg in 153 patients on active treatment and by 1.3 ± 0.9/1.0 ± 0.5 mm Hg in 167 patients on placebo. Improvement of TOD occurred in 79 patients randomised to active treatment and in 49 patients on placebo: 51.6% (95% CI 43.7%, 59.5%) versus 29.3% (22.1, 36.5%; p < 0.0001). Per-protocol and subgroup analyses were confirmatory. Adverse events were generally mild and occurred in 38 (25.3%) and 43 (26.4%) patients randomised to active treatment and placebo, respectively (p = 0.83).
UNASSIGNED: Our results suggest that antihypertensive treatment improves TOD in patients with masked hypertension, highlighting the need of treatment. However, the long-term benefit in preventing cardiovascular complications still needs to be established.
UNASSIGNED: Salubris China.