Wachter Rolf, Shah Sanjiv J, Cowie Martin R, Szecsödy Peter, Shi Victor, Ibram Ghionul, Zhao Ziqiang, Gong Jianjian, Klebs Sven, Pieske Burkert
Clinic and Policlinic for Cardiology, University Hospital Leipzig, Leipzig, Germany.
Clinic for Cardiology and Pneumology, University Medical Center Göttingen and DZHK (German Center for Cardiovascular Research), partner site Göttingen, Göttingen, Germany.
ESC Heart Fail. 2020 Jun;7(3):856-864. doi: 10.1002/ehf2.12694. Epub 2020 Apr 15.
Although the effect of the angiotensin receptor blocker neprilysin inhibitor (ARNI) sacubitril/valsartan on heart failure (HF) hospitalizations and cardiovascular death has been evaluated, its effects on functional capacity in patients with HF and ejection fraction (EF) >40% has yet to be determined. In addition, no prior studies have compared sacubitril/valsartan with angiotensin-converting enzyme inhibitor therapy. We sought to compare the effect of ARNI to background-medication-based individualized comparators (BMICs) on N-terminal pro-B-type natriuretic peptide (NT-proBNP), functional capacity [6 min walk distance (6MWD)], symptoms, and quality of life [Kansas City Cardiomyopathy Questionnaire (KCCQ)] in patients with HF and EF >40% in a randomized clinical trial.
PARALLAX is a prospective, randomized, controlled, double-blind multicentre clinical trial in patients with chronic symptomatic HF with EF >40%, New York Heart Association (NYHA) class II-IV symptoms, elevated natriuretic peptides, and evidence of structural heart disease. Eligible patients are randomized to sacubitril/valsartan vs. BMIC for cardiovascular and related co-morbidities. BMIC includes (i) enalapril, (ii) valsartan, and (iii) placebo depending on the type of medical therapy prior to enrolment. The primary endpoints are the change in plasma NT-proBNP concentration from baseline to 12 weeks and the change from baseline in 6MWD distance at 24 weeks. The secondary endpoints assess quality of life and symptom burden.
PARALLAX will determine if sacubitril/valsartan compared with standard medical therapy for co-morbidities improves NT-proBNP levels, exercise capacity, quality of life, and symptom burden in HF patients with EF >40%.
尽管血管紧张素受体脑啡肽酶抑制剂（ARNI）沙库巴曲缬沙坦对心力衰竭（HF）住院率和心血管死亡的影响已得到评估，但其对射血分数（EF）>40%的HF患者功能能力的影响尚未确定。此外，既往尚无研究将沙库巴曲缬沙坦与血管紧张素转换酶抑制剂治疗进行比较。我们试图在一项随机临床试验中，比较ARNI与基于背景药物的个体化对照药物（BMIC）对EF>40%的HF患者N末端B型利钠肽原（NT-proBNP）、功能能力[6分钟步行距离（6MWD）]、症状及生活质量[堪萨斯城心肌病问卷（KCCQ）]的影响。
PARALLAX是一项针对慢性症状性HF、EF>40%、纽约心脏协会（NYHA）II-IV级症状、利钠肽升高且有结构性心脏病证据患者的前瞻性、随机、对照、双盲多中心临床试验。符合条件的患者被随机分配接受沙库巴曲缬沙坦或BMIC治疗心血管疾病及相关合并症。BMIC包括（i）依那普利，（ii）缬沙坦，以及（iii）安慰剂，具体取决于入组前的药物治疗类型。主要终点为从基线到12周时血浆NT-proBNP浓度的变化以及24周时6MWD距离相对于基线的变化。次要终点评估生活质量和症状负担。
PARALLAX将确定与合并症的标准药物治疗相比，沙库巴曲缬沙坦是否能改善EF>40%的HF患者的NT-proBNP水平、运动能力、生活质量和症状负担。
