Division of Nephrology, Department of Medicine, Massachusetts General Hospital, Boston, USA.
Am J Nephrol. 2011;33(2):139-49. doi: 10.1159/000323551. Epub 2011 Jan 18.
In chronic kidney disease (CKD), left ventricular hypertrophy (LVH) is prevalent and is associated with increased cardiovascular morbidity and mortality. Vitamin D receptor (VDR) activation attenuates LVH progression in animal models.
PRIMO is a multinational, randomized, double-blinded trial with oral paricalcitol in subjects with stages 3-4 CKD, mild-to-moderate LVH and an LV ejection fraction >50%. The primary endpoint is change in the left ventricular mass index (LVMI) compared with placebo after 48 weeks of treatment. The main secondary endpoints are changes in diastolic function parameters. In this paper, we report baseline characteristics from this study.
LVMI was 33.0 ± 7.5 g/m(2.7) for males and 30.8 ± 7.2 g/m(2.7) for females (p = 0.04). LVMI correlated with systolic blood pressure (r = 0.24), urine albumin creatinine ratio (r = 0.39), troponin T (r = 0.29), high-sensitivity C-reactive protein (r = 0.25) and plasma levels of B-type brain natriuretic peptide (r = 0.22); all p < 0.01. In multiple linear regression, each remained independently associated with LVMI. The early diastolic velocity of the lateral mitral annulus (E') was 8.1 ± 2.4 cm/s. E' was inversely correlated with age in univariate (r = -0.14, p = 0.04) and multivariable (p = 0.02) analysis.
Among 227 multinational subjects with stages 3-4 CKD, baseline LVMI correlates with baseline blood pressure, urine albumin creatinine ratio and cardiac biomarkers, and baseline diastolic function correlates with age. This research was funded by Abbott Laboratories; ClinicalTrials.gov No. NCT00497146.
在慢性肾脏病(CKD)中,左心室肥厚(LVH)很常见,并且与心血管发病率和死亡率的增加有关。维生素 D 受体(VDR)的激活可减轻动物模型中 LVH 的进展。
PRIMO 是一项多中心、随机、双盲试验,在 3-4 期 CKD、轻度至中度 LVH 和左心室射血分数>50%的患者中进行口服帕立骨化醇治疗。主要终点是与安慰剂相比,治疗 48 周后左心室质量指数(LVMI)的变化。主要次要终点是舒张功能参数的变化。本文报告了该研究的基线特征。
男性的 LVMI 为 33.0±7.5g/m(2.7),女性为 30.8±7.2g/m(2.7)(p=0.04)。LVMI 与收缩压(r=0.24)、尿白蛋白肌酐比(r=0.39)、肌钙蛋白 T(r=0.29)、高敏 C 反应蛋白(r=0.25)和 B 型脑钠肽(r=0.22)呈正相关(均 p<0.01)。多元线性回归分析显示,各因素均与 LVMI 独立相关。外侧二尖瓣环舒张早期速度(E')为 8.1±2.4cm/s。E'与年龄呈负相关(单变量 r=-0.14,p=0.04;多变量 p=0.02)。
在 227 名来自多个国家的 3-4 期 CKD 患者中,LVMI 与基线血压、尿白蛋白肌酐比和心脏标志物相关,舒张功能与年龄相关。该研究由 Abbott 实验室资助;ClinicalTrials.gov 编号 NCT00497146。