Department of Cardiology, Academic Medical Center, Amsterdam, Netherlands.
Circulation. 2013 Jan 22;127(3):322-30. doi: 10.1161/CIRCULATIONAHA.112.135392. Epub 2012 Dec 17.
The role of angiotensin II receptor blockers in patients with a systemic right ventricle has not been elucidated.
We conducted a multicenter, double-blind, parallel, randomized controlled trial of angiotensin II receptor blocker valsartan 160 mg twice daily compared with placebo in patients with a systemic right ventricle caused by congenitally or surgically corrected transposition of the great arteries. The primary end point was change in right ventricular ejection fraction during 3-year follow-up, determined by cardiovascular magnetic resonance imaging or, in patients with contraindication for magnetic resonance imaging, multirow detector computed tomography. Secondary end points were change in right ventricular volumes and mass, Vo(2)peak, and quality of life. Primary analyses were performed on an intention-to-treat basis. A total of 88 patients (valsartan, n=44; placebo, n=44) were enrolled in the trial. No serious adverse effects occurred in either group. There was no significant effect of 3-year valsartan therapy on systemic right ventricular ejection fraction (treatment effect, 1.3%; 95% confidence interval, -1.3% to 3.9%; P=0.34), maximum exercise capacity, or quality of life. There was a larger increase in right ventricular end-diastolic volume (15 mL; 95% confidence interval, 3-28 mL; P<0.01) and mass (8 g; 95% confidence interval, 2-14 g; P=0.01) in the placebo group than in the valsartan group.
There was no significant treatment effect of valsartan on right ventricular ejection fraction, exercise capacity, or quality of life. Valsartan was associated with a similar frequency of significant clinical events as placebo. Small but significant differences between valsartan and placebo were present for change in right ventricular volumes and mass.
URL: http://www.controlled-trials.com. Unique identifier: ISRCTN52352170.
血管紧张素 II 受体阻滞剂在体循环右心室患者中的作用尚未阐明。
我们进行了一项多中心、双盲、平行、随机对照试验，比较血管紧张素 II 受体阻滞剂缬沙坦 160mg 每日两次与安慰剂在由先天性或手术矫正的大动脉转位引起的体循环右心室患者中的作用。主要终点是 3 年随访期间右心室射血分数的变化，通过心血管磁共振成像或在磁共振成像禁忌的患者中通过多排探测器计算机断层扫描来确定。次要终点是右心室容积和质量、Vo2 峰值和生活质量的变化。主要分析基于意向治疗进行。共有 88 例患者（缬沙坦组 44 例，安慰剂组 44 例）入组该试验。两组均未发生严重不良事件。3 年缬沙坦治疗对体循环右心室射血分数无显著影响（治疗效果为 1.3%；95%置信区间为-1.3%至 3.9%；P=0.34）、最大运动能力或生活质量。与缬沙坦组相比，安慰剂组的右心室舒张末期容积（增加 15 毫升；95%置信区间为 3 至 28 毫升；P<0.01）和质量（增加 8 克；95%置信区间为 2 至 14 克；P=0.01）增加更大。
缬沙坦对右心室射血分数、运动能力或生活质量无显著治疗作用。缬沙坦与安慰剂相比，发生重大临床事件的频率相似。缬沙坦与安慰剂相比，右心室容积和质量的变化存在较小但有统计学意义的差异。
