BACKGROUND The aims of this study were to: (i) report the baseline characteristics of patients enrolled in the Dapagliflozin And Prevention of Adverse-outcomes in Heart Failure (DAPA-HF) trial, (ii) compare DAPA-HF patients to participants in contemporary heart failure (HF) registries and in other recent HF trials, and (iii) compare individuals with diabetes, pre-diabetes and a normal glycated haemoglobin (HbA1c) in DAPA-HF. METHODS AND RESULTS Adults with HF in New York Heart Association functional class ≥ II, a left ventricular ejection fraction ≤ 40%, an elevated N-terminal pro-B-type natriuretic peptide concentration and receiving standard treatment were eligible for DAPA-HF, which is comparing dapagliflozin 10 mg once daily to matching placebo. In patients without a history of diabetes, previously undiagnosed diabetes was defined as a confirmed HbA1c ≥ 6.5%. Among patients without known or undiagnosed diabetes, pre-diabetes was defined as a HbA1c ≥ 5.7% The remainder of patients, with a HbA1c < 5.7%, were defined as normoglycaemic. Of the 4744 patients (mean age 66 years; 23% women) randomized, 42% had known diabetes and 3% undiagnosed diabetes. Of the remainder, 67% had pre-diabetes and 33% normal HbA1c. Overall, DAPA-HF patients were generally similar to those in recent registries and in relevant trials and had high levels of background therapy: 94% angiotensin-converting enzyme inhibitor/angiotensin receptor blocker/angiotensin receptor-neprilysin inhibitor, 96% beta-blocker, and 71% mineralocorticoid receptor antagonist; 26% had a defibrillator. Patients with diabetes had worse HF status, more co-morbidity, and greater renal impairment but received similar HF therapy. Patients with diabetes received non-insulin hypoglycaemic therapy alone in 49%, insulin alone in 11%, both in 14%, and none in 26%. CONCLUSIONS Patients randomized in DAPA-HF were similar to those in other contemporary HF with reduced ejection fraction (HFrEF) registries and trials. These patients were receiving recommended HFrEF therapy and those with diabetes were also treated with conventional glucose-lowering therapy. Consequently, DAPA-HF will test the incremental efficacy and safety of dapagliflozin in HFrEF patients with and without diabetes. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov Identifier NCT03036124.

中文翻译：

---

Dapagliflozin和预防心力衰竭的不良结果（DAPA-HF）试验：基线特征。

背景技术这项研究的目的是：（i）报告参加Dapagliflozin和预防心力衰竭不良后果（DAPA-HF）试验的患者的基线特征，（ii）将DAPA-HF患者与当代受试者进行比较心力衰竭（HF）注册表以及其他最近的HF试验中，以及（iii）在DAPA-HF中比较患有糖尿病，糖尿病前期和糖化血红蛋白（HbA1c）正常的个体。方法和结果纽约心脏协会功能性分类≥II，左心室射血分数≤40％，N端前B型利尿钠肽浓度升高并接受标准治疗的成人HF符合DAPA-HF的标准。将每天一次的dapagliflozin 10 mg与匹配的安慰剂进行比较。在没有糖尿病史的患者中，先前未诊断的糖尿病定义为确诊的HbA1c≥6.5％。在没有已知或未经诊断的糖尿病的患者中，糖尿病前定义为HbA1c≥5.7％，其余患者HbA1c <5.7％被定义为血糖正常。在4744名患者中（平均年龄66岁； 23％为女性），其中42％患有已知糖尿病和3％未被诊断的糖尿病。在其余的患者中，有67％患有糖尿病前期，而33％的正常HbA1c。总体而言，DAPA-HF患者通常与最近的登记处和相关试验中的患者相似，并且接受了高水平的背景治疗：94％的血管紧张素转换酶抑制剂/血管紧张素受体阻滞剂/血管紧张素受体-中性溶酶抑制剂，96％的β-受体阻滞剂，和71％的盐皮质激素受体拮抗剂；26％的人有除颤器。糖尿病患者的心衰状态较差，合并症较多，肾功能损害更大，但接受了类似的HF治疗。糖尿病患者仅接受非胰岛素降糖治疗的比例为49％，仅接受胰岛素的比例为11％，均接受14％的比例，没有接受26％的比例。结论在DAPA-HF中随机分组的患者与射血分数降低（HFrEF）登记和试验的其他当代HF患者相似。这些患者正在接受推荐的HFrEF治疗，而糖尿病患者也接受了常规的降糖治疗。因此，DAPA-HF将测试达格列净在有无糖尿病的HFrEF患者中的递增疗效和安全性。临床试验注册ClinicalTrials.gov标识符NCT03036124。26％的受访者中没有一个。结论在DAPA-HF中随机分组的患者与射血分数降低（HFrEF）登记和试验的其他当代HF患者相似。这些患者正在接受推荐的HFrEF治疗，而糖尿病患者也接受了常规的降糖治疗。因此，DAPA-HF将测试达格列净在有无糖尿病的HFrEF患者中的递增疗效和安全性。临床试验注册ClinicalTrials.gov标识符NCT03036124。26％的受访者中没有一个。结论在DAPA-HF中随机分组的患者与射血分数降低（HFrEF）登记和试验的其他当代HF患者相似。这些患者正在接受推荐的HFrEF治疗，而糖尿病患者也接受了常规的降糖治疗。因此，DAPA-HF将测试达格列净在有无糖尿病的HFrEF患者中的递增疗效和安全性。临床试验注册ClinicalTrials.gov标识符NCT03036124。DAPA-HF将测试达格列净在有和没有糖尿病的HFrEF患者中的递增疗效和安全性。临床试验注册ClinicalTrials.gov标识符NCT03036124。DAPA-HF将测试达格列净在有和没有糖尿病的HFrEF患者中的递增疗效和安全性。临床试验注册ClinicalTrials.gov标识符NCT03036124。