Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (S.D.S., M.A.P.).
Novartis Pharmaceuticals Corporation, East Hanover, NJ (V.C.S., A.R.R., J.J.G., M.P.L.).
Circ Heart Fail. 2018 Jul;11(7):e004962. doi: 10.1161/CIRCHEARTFAILURE.118.004962.
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.
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.
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.
URL: https://www.clinicaltrials.gov. Unique identifier: NCT01920711.
描述心力衰竭和左心室射血分数保留患者的基线特征，这些患者参与了 PARAGON-HF 试验（心力衰竭和射血分数保留的前瞻性比较：血管紧张素受体脑啡肽酶抑制剂与血管紧张素受体阻滞剂在 HFpEF 中的全球结局），比较了 sacubitril/valsartan 与 valsartan 在降低发病率和死亡率方面的效果。
我们报告了 4822 名随机分配到 PARAGON-HF 的患者的关键人口统计学、临床和实验室发现，以及基线治疗情况，这些患者按影响研究纳入标准的因素进行分组。我们还比较了 PARAGON-HF 纳入患者的基线特征与其他近期心力衰竭和射血分数保留试验（HFpEF）的患者。在来自不同地区（亚太地区 16%、中欧 37%、拉丁美洲 7%、北美 12%、西欧 28%）的纳入患者中，PARAGON-HF 纳入患者的平均年龄为 72.7±8.4 岁，52%为女性，平均左心室射血分数为 57.5%，与其他 HFpEF 试验相似。大多数患者处于纽约心脏协会心功能分级 II 级，38%在过去 9 个月内因心力衰竭住院治疗≥1 次。糖尿病（43%）和慢性肾脏病（47%）比之前的 HFpEF 试验更为常见。许多患者服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%）。按照方案规定，几乎所有患者都使用利尿剂，血浆 N 末端脑钠肽前体（pro-BNP）浓度升高（中位数 911 pg/mL；四分位距 464-1610），并存在结构性心脏病。
PARAGON-HF 代表了一组具有类似年龄和性别分布的当代心力衰竭和射血分数保留患者，与之前的心力衰竭和射血分数保留试验相比，但合并症的患病率更高。这些发现提供了有关纳入标准对心力衰竭和射血分数保留患者特征的影响以及区域差异的见解。
