标准化运动训练对射血分数保留的心力衰竭相关肺动脉高压患者（TRAIN-HFpEF-PH）的安全性和有效性：一项随机对照多中心试验的研究方案。
Safety and effectiveness of standardized exercise training in patients with pulmonary hypertension associated with heart failure with preserved ejection fraction (TRAIN-HFpEF-PH): study protocol for a randomized controlled multicenter trial.
机构信息
Clinic of Cardiac and Vascular Diseases, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, Santariskiu-2, 08661, Vilnius, Lithuania.
Faculty of Medicine, Vilnius University, Vilnius, Lithuania.
出版信息
Trials. 2023 Apr 19;24(1):281. doi: 10.1186/s13063-023-07297-x.
BACKGROUND
Left heart failure (HF) is characterized by an elevation in left-sided filling pressures, causing symptoms of dyspnea, impairing exercise capacity, and leading to pulmonary venous congestion and secondary pulmonary hypertension (PH). There is an increased incidence of PH associated with left heart disease, particularly with heart failure with preserved ejection fraction (HFpEF-PH). Treatment possibilities in HFpEF-PH are non-specific and very limited, thus additional pharmacological and non-pharmacological therapeutic strategies are needed. Various types of exercise-based rehabilitation programs have been shown to improve exercise capacity and quality of life (QoL) of HF and PH patients. However, no study focused on exercise training in the population of HFpEF-PH. This study is designed to investigate whether a standardized low-intensity exercise and respiratory training program is safe and may improve exercise capacity, QoL, hemodynamics, diastolic function, and biomarkers in patients with HFpEF-PH.
METHODS
A total of 90 stable patients with HFpEF-PH (World Health Organization functional class II-IV) will be randomized (1:1) to receive a 15-week specialized low-intensity rehabilitation program, including exercise and respiratory therapy and mental gait training, with an in-hospital start, or standard care alone. The primary endpoint of the study is a change in 6-min walk test distance; secondary endpoints are changes in peak exercise oxygen uptake, QoL, echocardiographic parameters, prognostic biomarkers, and safety parameters.
DISCUSSION
To date, no study has investigated the safety and efficacy of exercising specifically in the HFpEF-PH population. We believe that a randomized controlled multicenter trial, which protocol we are sharing in this article, will add important knowledge about the potential utility of a specialized low-intensity exercise and respiratory training program for HFpEF-PH and will be valuable in finding optimal treatment strategies for these patients.
TRIAL REGISTRATION
ClinicalTrials.gov NCT05464238. July 19, 2022.
背景
左心衰竭（HF）的特征是左侧充盈压升高，导致呼吸困难症状，运动能力受损，并导致肺静脉充血和继发性肺动脉高压（PH）。与左心疾病相关的 PH 发生率增加，特别是射血分数保留的心力衰竭（HFpEF-PH）。HFpEF-PH 的治疗选择是非特异性的，非常有限，因此需要额外的药理学和非药理学治疗策略。各种类型的基于运动的康复计划已被证明可改善 HF 和 PH 患者的运动能力和生活质量（QoL）。然而，没有研究专注于 HFpEF-PH 人群的运动训练。本研究旨在探讨标准化低强度运动和呼吸训练方案是否安全，并可能改善 HFpEF-PH 患者的运动能力、QoL、血液动力学、舒张功能和生物标志物。
方法
总共 90 名稳定的 HFpEF-PH 患者（世界卫生组织功能分类 II-IV）将被随机（1:1）分为接受 15 周专门的低强度康复计划的组，包括运动和呼吸治疗以及心理步态训练，住院开始，或单独接受标准护理。研究的主要终点是 6 分钟步行测试距离的变化；次要终点是峰值运动摄氧量、QoL、超声心动图参数、预后生物标志物和安全性参数的变化。
讨论
迄今为止，没有研究调查专门针对 HFpEF-PH 人群进行运动的安全性和有效性。我们相信，我们在本文中分享的这项随机对照多中心试验将增加关于专门的低强度运动和呼吸训练方案对 HFpEF-PH 的潜在效用的重要知识，并将为这些患者寻找最佳治疗策略提供有价值的信息。
试验注册
ClinicalTrials.gov NCT05464238。2022 年 7 月 19 日。
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