Background: To describe the baseline characteristics of patients with heart failure and preserved left ventricular ejection fraction enrolled in the PARAGON-HF trial (Prospective Comparison of Angiotensin Receptor Neprilysin Inhibitor With Angiotensin Receptor Blocker Global Outcomes in HFpEF) comparing sacubitril/valsartan to valsartan in reducing morbidity and mortality.

Methods and Results: We report key demographic, clinical, and laboratory findings, and baseline therapies, of 4822 patients randomized in PARAGON-HF, grouped by factors that influence criteria for study inclusion. We further compared baseline characteristics of patients enrolled in PARAGON-HF with those patients enrolled in other recent trials of heart failure with preserved ejection fraction (HFpEF). Among patients enrolled from various regions (16% Asia-Pacific, 37% Central Europe, 7% Latin America, 12% North America, 28% Western Europe), the mean age of patients enrolled in PARAGON-HF was 72.7±8.4 years, 52% of patients were female, and mean left ventricular ejection fraction was 57.5%, similar to other trials of HFpEF. Most patients were in New York Heart Association class II, and 38% had ≥1 hospitalizations for heart failure within the previous 9 months. Diabetes mellitus (43%) and chronic kidney disease (47%) were more prevalent than in previous trials of HFpEF. Many patients were prescribed angiotensin-converting enzyme inhibitors or angiotensin receptor blockers (85%), β-blockers (80%), calcium channel blockers (36%), and mineralocorticoid receptor antagonists (24%). As specified in the protocol, virtually all patients were on diuretics, had elevated plasma concentrations of N-terminal pro-B-type natriuretic peptide (median, 911 pg/mL; interquartile range, 464–1610), and structural heart disease.

Conclusions: PARAGON-HF represents a contemporary group of patients with HFpEF with similar age and sex distribution compared with prior HFpEF trials but higher prevalence of comorbidities. These findings provide insights into the impact of inclusion criteria on, and regional variation in, HFpEF patient characteristics.

CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01920711.

背景：为了描述心力衰竭和保留左心室射血分数的患者的基线特征，该研究参加了PARAGON-HF试验（在HFpEF中将血管紧张素受体中性溶酶抑制剂与血管紧张素受体阻滞剂的全球疗效进行了前瞻性比较），比较了沙比特利/缬沙坦与缬沙坦在降低发病率和死亡率。

方法和结果：我们报告了P​​ARAGON-HF中随机分组的4822例患者的主要人口统计学，临床和实验室发现以及基线疗法，这些因素按影响研究纳入标准的因素分组。我们进一步比较了参加PARAGON-HF的患者的基线特征与参加其他最近的保留射血分数（HFpEF）的心力衰竭试验的患者的基线特征。在来自各个地区（16％的亚太地区，37％的中欧，7％的拉丁美洲，12％的北美，28％的西欧）的患者中，PARAGON-HF的患者平均年龄为72.7±8.4岁， 52％的患者为女性，平均左心室射血分数为57.5％，与其他HFpEF试验相似。大多数患者属于纽约心脏协会的II级患者，在前9个月内，有38％的患者因心力衰竭住院治疗≥1次。糖尿病（43％）和慢性肾脏病（47％）比以前的HFpEF试验更为普遍。许多患者被处方使用血管紧张素转换酶抑制剂或血管紧张素受体阻滞剂（85％），β受体阻滞剂（80％），钙通道阻滞剂（36％）和盐皮质激素受体拮抗剂（24％）。根据方案中的规定，几乎所有患者都在使用利尿剂，血浆血浆N端前B型利尿钠肽浓度升高（中位数为911 pg / mL；四分位间距为464-1610），并患有结构性心脏病。和盐皮质激素受体拮抗剂（24％）。根据方案中的规定，几乎所有患者都在使用利尿剂，血浆血浆N端前B型利尿钠肽浓度升高（中位数为911 pg / mL；四分位间距为464-1610），并患有结构性心脏病。和盐皮质激素受体拮抗剂（24％）。根据方案中的规定，几乎所有患者都在使用利尿剂，血浆血浆N端前B型利尿钠肽浓度升高（中位数为911 pg / mL；四分位间距为464-1610），并患有结构性心脏病。

结论： PARAGON-HF代表了当代的HFpEF患者组，与先前的HFpEF试验相比，其年龄和性别分布相似，但合并症的患病率更高。这些发现提供了对入选标准对HFpEF患者特征的影响以及区域差异的见解。

临床试验注册： URL：https://www.clinicaltrials.gov。唯一标识符：NCT01920711。