Collister David, Pyne Lonnie, Bhasin Arrti A, Smyth Brendan, Herrington William, Jardine Meg, Mark Patrick B, Badve Sunil, Rossignol Patrick, Dember Laura M, Wanner Christoph, Ezekowitz Justin, Devereaux P J, Parfrey Patrick, Gansevoort Ron, Walsh Michael
Division of Nephrology, Department of Medicine, University of Alberta, Edmonton, Canada.
Population Health Research Institute, Hamilton, Canada.
Nephrol Dial Transplant. 2025 Feb 4;40(2):371-384. doi: 10.1093/ndt/gfae156.
Heart failure is characterized as cardiac dysfunction resulting in elevated cardiac filling pressures with symptoms and signs of congestion. Distinguishing heart failure from other causes of similar presentations in patients with kidney failure is challenging but necessary, and is needed in randomized controlled trials (RCTs) to accurately estimate treatment effects. The objective of this study was to review heart failure events, their diagnostic criteria, and adjudication in RCTs of patients with kidney failure treated with dialysis. We hypothesized that heart failure events, diagnostic criteria, and adjudication were infrequently reported in RCTs in dialysis.
We conducted a meta-epidemiologic systematic review of RCTs from high-impact medical, nephrology, and cardiology journals from 2000 to 2020. RCTs were eligible if they enrolled adults receiving maintenance dialysis for kidney failure and evaluated any intervention.
Of 561 RCTs in patients receiving dialysis, 36 (6.4%) reported heart failure events as primary (10, 27.8%) or secondary (31, 86.1%) outcomes. Ten of the 36 (27.8%) RCTs provided heart failure event diagnostic criteria and five of these (50%) adjudicated heart failure events. These 10 RCTs included event diagnostic criteria for heart failure or heart failure hospitalizations, and their criteria included dyspnoea (5/10), oedema (2/10), rales/crackles (4/10), chest X-ray pulmonary oedema or vascular redistribution (4/10), treatment in an acute setting (6/10), and ultrafiltration or dialysis (4/10). No study explicitly distinguished heart failure from volume overload secondary to non-adherence or underdialysis.
Overall, we found that heart failure events are infrequently reported in RCTs in dialysis and are heterogeneously defined. Further research is required to develop standardized diagnostic criteria that are practical and meaningful to patients and clinicians.
心力衰竭的特征为心脏功能障碍，导致心脏充盈压升高，并伴有充血的症状和体征。在肾衰竭患者中，将心力衰竭与其他具有相似表现的病因区分开来具有挑战性，但却是必要的，这在随机对照试验（RCT）中对于准确估计治疗效果是必需的。本研究的目的是回顾心力衰竭事件、其诊断标准以及在接受透析治疗的肾衰竭患者的RCT中的判定情况。我们假设在透析的RCT中，心力衰竭事件、诊断标准和判定情况很少被报告。
我们对2000年至2020年高影响力医学、肾脏病学和心脏病学杂志上的RCT进行了一项元流行病学系统评价。如果RCT纳入了接受维持性透析治疗肾衰竭的成年人并评估了任何干预措施，则该RCT符合纳入标准。
在561项针对接受透析患者的RCT中，36项（6.4%）将心力衰竭事件报告为主要（10项，27.8%）或次要（31项，86.1%）结局。36项RCT中的10项（27.8%）提供了心力衰竭事件诊断标准；其中5项（50%）对心力衰竭事件进行了判定。这10项RCT包括心力衰竭或心力衰竭住院的事件诊断标准，其标准包括呼吸困难（5/10）、水肿（2/10）、啰音/爆裂音（4/10）、胸部X线显示肺水肿或血管再分布（4/10）、急性情况下的治疗（6/10）以及超滤或透析（4/10）。没有研究明确区分心力衰竭与因不依从或透析不足导致的容量超负荷。
总体而言，我们发现透析的RCT中很少报告心力衰竭事件，且定义存在异质性。需要进一步研究以制定对患者和临床医生实用且有意义的标准化诊断标准。
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