心力衰竭患者早期整合姑息关怀与标准心脏护理（EPCHF）：一项多中心、平行、双臂、开放标签、随机对照试验。

IF 13.4 Q1 GERIATRICS & GERONTOLOGY

Lancet Healthy Longevity Pub Date : 2024-10-01 DOI:10.1016/j.lanhl.2024.08.006

Mahmoud Balata MD , Prof Lukas Radbruch MD , Michaela Hesse MD , Prof Ralf Westenfeld MD , Martin Neukirchen MD , Prof Roman Pfister MD , Yann-Nicolas Batzler MD , Can Öztürk MD , Refik Kavsur MD , Vedat Tiyerili MD , Prof Birgitta Weltermann MD , Robert Pölsler MD , Prof Thomas Standl MD , Prof Georg Nickenig MD , Prof Marc Ulrich Becher MD , Heart Failure Network Rhineland

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引用次数: 0

摘要

背景：心力衰竭是一个严重影响患者生活质量的全球性健康问题。我们旨在比较早期整合姑息治疗（EIPC）和标准心脏治疗对非终末期心力衰竭患者健康状况和情绪的影响：EPCHF是一项多中心、平行、双臂、开放标签、随机对照试验，在德国波恩大学医院和杜塞尔多夫大学医院进行。符合条件的患者（18 岁或以上）均患有心力衰竭，纽约心脏协会分级为 II 级或以上，NT-proBNP 浓度大于或等于 400 pg/mL。患者被随机分配（1:1）接受 EIPC 和标准心脏治疗，或仅接受标准心脏治疗。随机分配由计算机生成，采用分配隐藏、可变区块大小和按研究地点分层的方式。主要终点是健康状况和情绪，在12个月内每3个月使用慢性疾病治疗-姑息治疗功能评估（FACIT-PAL）和堪萨斯城心肌病问卷（KCCQ）进行测量，并按意向治疗进行分析。该试验已在DRKS.de注册，编号为DRKS00013922.Findings：2019年5月21日至2021年11月15日期间，843名患者接受了资格评估，其中205名患者入选（100名被分配至EIPC，105名被分配至标准心脏护理）。143名患者（70%）为男性，62名患者（30%）为女性。在12个月内，两组患者的FACIT-PAL和KCCQ综合评分（OSS）均有明显改善，组间无明显差异（FACIT-PAL调整后平均差异为0-98分[95% CI -1-28 to 3-23]；P=0-40；KCCQ-OSS调整后平均差异为-2-06分[-7-89 to 3-78]；P=0-49）。EIPC组有9名（9%）患者因任何原因死亡，标准心脏护理组有7名（7%）患者因任何原因死亡，两组患者的死亡时间无显著差异（危险比[HR] 1-32 [95% CI 0-49 to 3-54]; p=0-58）。EIPC组22（22%）名患者和标准心脏护理组21（21%）名患者因心衰至少住院一次，两组患者因心衰住院的时间无显著差异（HR 1-09 [0-61 to 1-98]; p=0-77）。EIPC组有70名（70%）患者出现不良事件，标准心脏护理组有62名（59%）患者出现不良事件（P=0-10）：在这项开放标签、随机临床试验中发现，标准心脏治疗，包括以指南为指导的优化药物治疗和3个月定期随访，在改善非终末期心力衰竭患者的健康状况和情绪方面与EIPC联合治疗同样有效。未来的临床实践应根据患者的个体需求考虑EIPC：联邦教育与研究部。

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Early integration of palliative care versus standard cardiac care for patients with heart failure (EPCHF): a multicentre, parallel, two-arm, open-label, randomised controlled trial

Background

Heart failure is a substantial global health concern that severely affects patients' quality of life. We aimed to compare the effects of early integration of palliative care (EIPC) and standard cardiac care on health status and mood of patients with non-terminal heart failure.

Methods

EPCHF was a multicentre, parallel, two-arm, open-label, randomised controlled trial carried out at University Hospital Bonn and University Hospital Düsseldorf in Germany. Eligible patients (aged 18 years or older) had heart failure, with New York Heart Association class II or more and NT-proBNP concentrations greater than or equal to 400 pg/mL. Patients were randomly assigned (1:1) to receive EIPC with standard cardiac care or standard cardiac care alone. Randomisation was computer-generated with allocation concealment, variable block sizes, and stratification by investigational site. The primary endpoints were health status and mood, measured every 3 months over 12 months using the Functional Assessment of Chronic Illness Therapy–Palliative Care (FACIT–PAL) and the Kansas City Cardiomyopathy Questionnaire (KCCQ), analysed by intention to treat. This trial is registered with DRKS.de, DRKS00013922.

Findings

Between May 21, 2019, and Nov 15, 2021, 843 patients were assessed for eligibility, 205 of whom were enrolled (100 assigned to EIPC and 105 assigned to standard cardiac care). 143 (70%) patients were male and 62 (30%) were female. Over 12 months, both groups significantly improved in FACIT–PAL and KCCQ Overall Summary Score (OSS) with no significant differences between the groups (FACIT–PAL adjusted mean difference 0·98 points [95% CI –1·28 to 3·23]; p=0·40; KCCQ-OSS adjusted mean difference –2·06 points [–7·89 to 3·78]; p=0·49). Nine (9%) patients in the EIPC group and seven (7%) patients in the standard cardiac care group died from any cause, with no significant differences in time to death between the two groups (hazard ratio [HR] 1·32 [95% CI 0·49 to 3·54]; p=0·58). 22 (22%) patients in the EIPC group and 21 (21%) patients in the standard cardiac care group were hospitalised at least once due to heart failure, with no significant differences in time to heart-failure-related hospitalisation between the two groups (HR 1·09 [0·61 to 1·98]; p=0·77). 70 (70%) patients in the EIPC group and 62 (59%) in the standard cardiac care group had any adverse events (p=0·10).

Interpretation

In this open-label, randomised clinical trial, standard cardiac care, featuring guideline-directed optimisation of medical therapy and regular 3-monthly follow-ups was found to be as effective as when combined with EIPC in improving health status and mood in patients with non-terminal heart failure. Future clinical practices should consider EIPC based on individual patient needs.

Funding

Federal Ministry of Education and Research.

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来源期刊

Lancet Healthy Longevity GERIATRICS & GERONTOLOGY-

CiteScore

16.30

自引率

2.30%

发文量

192

审稿时长

12 weeks

期刊介绍： The Lancet Healthy Longevity, a gold open-access journal, focuses on clinically-relevant longevity and healthy aging research. It covers early-stage clinical research on aging mechanisms, epidemiological studies, and societal research on changing populations. The journal includes clinical trials across disciplines, particularly in gerontology and age-specific clinical guidelines. In line with the Lancet family tradition, it advocates for the rights of all to healthy lives, emphasizing original research likely to impact clinical practice or thinking. Clinical and policy reviews also contribute to shaping the discourse in this rapidly growing discipline.