University Hospitals of Derby and Burton, Derby, UK
University of Manchester, Manchester, UK.
Perit Dial Int. 2019 Sep-Oct;39(5):486-489. doi: 10.3747/pdi.2018.00272.
Peritoneal ultrafiltration (PuF) has been employed for severe heart failure (HF), but evidence for its benefit is lacking. The Peritoneal Dialysis for Heart Failure (PDHF) study was a multicenter prospective randomized controlled trial which aimed to investigate this issue. The trial stopped early due to inadequate recruitment. We describe methods, trial activity, and lessons learned.The trial aimed to recruit 130 participants with severe diuretic-resistant HF (New York Heart Association [NYHA] 3/4) and chronic kidney disease (CKD) stage 3/4 on optimal medical treatment for ≥ 4 weeks from 6 UK centers. Participants were randomized to either continuation of conventional HF treatment or to additionally receiving PuF (1 overnight exchange using Icodextrin dialysate). Primary outcome was change in 6-minute walk test (6MWT) between baseline and 28 weeks (end of trial). Secondary outcomes were changes in patient reported quality of life as assessed by the Kansas City Cardiomyopathy Questionnaire, short form 36 (SF 36) health survey results, hospitalization, and mortality.Over a 2-year period, 290 patients were screened from which only 20 met inclusion criteria and 10 were recruited. Reasons for ineligibility were fluctuating estimated glomerular filtration rate (eGFR), suboptimal HF treatment, frailty, and patients being too unwell for randomization. Barriers to recruitment included patient frailty, with some participants considered only when they were at end of life, unwillingness to engage in an invasive therapy, and suboptimal coordination between cardiology and renal services. This is a challenging patient group in which to perform research, and lessons learned from the peritoneal dialysis (PD)-HF trial will be helpful in the planning of future studies in this area.
腹膜超滤（PuF）已被用于治疗严重心力衰竭（HF），但缺乏其获益的证据。腹膜透析治疗心力衰竭（PDHF）研究是一项多中心前瞻性随机对照试验，旨在研究这一问题。由于招募不足，该试验提前停止。我们描述了方法、试验活动和吸取的经验教训。该试验旨在从 6 个英国中心招募 130 名患有严重利尿剂抵抗性 HF（纽约心脏协会[NYHA]3/4 级）和慢性肾脏病（CKD）3/4 期且接受最佳药物治疗≥4 周的患者。参与者被随机分为继续接受常规 HF 治疗或另外接受 PuF（使用艾考糊精透析液进行 1 次夜间交换）。主要结局是基线至 28 周（试验结束时）的 6 分钟步行试验（6MWT）变化。次要结局是用堪萨斯城心肌病问卷、短表 36（SF 36）健康调查结果评估的患者报告的生活质量变化、住院和死亡率变化。在 2 年期间，从 290 名患者中进行了筛选，其中只有 20 名符合纳入标准，10 名被招募。不符合条件的原因是估算肾小球滤过率（eGFR）波动、HF 治疗不理想、虚弱以及患者因病情过重而无法进行随机分组。招募的障碍包括患者虚弱，有些参与者只有在生命末期才被考虑，不愿意接受侵入性治疗，以及心脏病学和肾脏服务之间的协调不理想。这是一个进行研究具有挑战性的患者群体，从 PDHF 试验中吸取的经验教训将有助于该领域未来研究的规划。
