Heart failure therapy in patients with advanced cancer receiving specialized palliative care (EMPATICC trial).

The trial evaluated safety and efficacy of HF therapy among patients with advanced cancer receiving specialized palliative care to improve patients' self-care ability.

该试验评估了在接收专门姑息治疗的晚期癌症患者中，心力衰竭疗法的安全性和有效性，以提高患者的自我护理能力。

Methods

Patients with stage 4 solid tumours with a life expectancy of 1-6 months receiving specialized palliative care were enrolled.

招募了预期生存期为1-6个月的IV期实体瘤患者，接受专门的姑息治疗。

Patients were required to meet at least two cardiovascular risk criteria and at least one criterion for functional limitation.

患者必须满足至少两项心血管风险标准和至少一项功能限制标准。

Participants were randomized 1:1 to receive optimized HF therapy (up to four drugs: sacubitril/valsartan, empagliflozin, ivabradine, ferric carboxymaltose) or placebo in a double-blindsetting.

参与者按1:1的比例随机接受优化的心力衰竭治疗（最多四种药物：沙库巴曲/缬沙坦、恩格列净、伊伐布雷定、羧甲司坦铁）或安慰剂，在双盲设置中进行。

The primary hierarchical endpoint included: (i) days alive and able to wash oneself, (ii) ability to walk 4 m, and (iii) self-reported patient global assessment (PGA) of subjective well-being, during the 30-day placebo-controlledphase.

主要的分层终点包括：(i) 活着且能够自行洗漱的天数，(ii) 能够行走4米的能力，以及(iii) 在30天安慰剂对照阶段期间，患者自我报告的主观健康状况的全球评估（PGA）。

Results

In five centres, 93 patients were randomized.

在五个中心，共有93名患者被随机分配。

The primary endpoint did not differ between groups (win ratio 0.95, 95% confidence interval[CI] 0.57-1.58; P = .83).

主要终点在两组之间没有差异（胜率比为0.95，95%置信区间[CI]为0.57-1.58；P = .83）。

Overall, mortality was 32% at 30 days (not different between groups).

总体而言，30天内的死亡率为32%（两组之间无差异）。

In patients alive at 30 days, HF therapy reduced N-terminal pro-B-type natriuretic peptide levels by 41% (P = .040), increased left ventricular ejection fraction by 2.9% (P = .036), and improved PGA scores (odds ratio 0.22, 95% CI 0.06-0.75; P = .016).

在30天后仍然存活的患者中，心力衰竭治疗使N末端B型利钠肽前体水平降低了41%（P = .040），左心室射血分数增加了2.9%（P = .036），并改善了PGA评分（优势比0.22，95%置信区间0.06-0.75；P = .016）。

Conclusions

In a population with advanced cancer receiving specialized palliative care and high early mortality, optimized HF therapy did not improve patients' self-care ability.

在接受专业姑息治疗且早期死亡率高的晚期癌症患者群体中，优化的心力衰竭治疗并未改善患者的自我护理能力。

Among survivors at 30 days, improvements in quality of life measures and cardiac biomarkers suggest potential benefit of individualized HF therapy, which is hypothesis generating and needs validation.

在30天存活者中，生活质量指标和心脏生物标志物的改善表明个性化心力衰竭治疗可能有益，这为假设提供了依据，但需要进一步验证。