Long-term effect of subcutaneous treprostinil in patients with pulmonary hypertension: rationale and design of the phase IV, multicentre, observational TREPAR-HP study

A. Lescano, N. Atamañuk, G. Bortman, J. Cáneva, M. Diez, G. Giacomi, L. Lema, E. Perna
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Abstract

Background: Pulmonary hypertension (PH) is a chronic, progressive condition with high morbidity and mortality due to right heart (RH) failure. Prognosis depends on RH adaptability and remodelling in response to increased pulmonary arterial pressure. There is little information regarding risk variables and prognostic factors in the Argentinian population, current risk scores have not been validated, and its impact on free-event survival is still unknown. Prostacyclin analogues are the first-line treatment for high-risk patients. However, there is limited evidence on its clinical benefits, long-term effects, and impact on RH remodelling in the Argentinian population.Methods: The study was designed as a national, multicentre, prospective, observational, phase IV study including 100 patients with pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension, treated with subcutaneous treprostinil and followed up for 48 months. The study will be conducted in parallel with the patients' standard management and treatment in each centre. The primary objective is to assess the long-term improvement or reversal of RH remodelling (RHRR) parameters obtained by echocardiography. Secondary objectives include the evaluation of the prognostic value of RHRR parameters and the rate of clinical events, the treatment effect in terms of pulmonary vascular resistance, right ventricle systolic function, morbidity and all-cause mortality, quality of life, and safety and tolerability.Conclusions: This study will help to determine the clinical benefits, long-term effects, and impact on RH remodelling of prostacyclin analogues in Argentina.Trial registration: The trial was registered at Registro Nacional de Investigaciones en Salud (RENIS) in Argentina (https://sisa.msal.gov.ar/sisa/#sisa; registration number IS003303).
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肺动脉高压患者皮下treprostiil的长期疗效:多中心观察性TREPAR-HP IV期研究的基本原理和设计
背景:肺动脉高压(PH)是一种由右心(RH)衰竭引起的慢性进行性疾病,发病率和死亡率高。预后取决于RH的适应性和肺动脉压升高后的重塑。关于阿根廷人群的风险变量和预后因素的信息很少,目前的风险评分尚未得到验证,其对无事件生存的影响仍然未知。前列环素类似物是高危患者的一线治疗药物。然而,关于其临床益处、长期效果和对阿根廷人群RH重塑的影响的证据有限。方法:该研究是一项全国性、多中心、前瞻性、观察性的IV期研究,纳入100例肺动脉高压或慢性血栓栓塞性肺动脉高压患者,接受皮下treprostiil治疗,随访48个月。该研究将在每个中心对患者进行标准管理和治疗的同时进行。主要目的是评估超声心动图获得的RH重构(RHRR)参数的长期改善或逆转。次要目的包括评价RHRR参数的预后价值和临床事件发生率、治疗效果(肺血管阻力、右心室收缩功能、发病率和全因死亡率、生活质量、安全性和耐受性)。结论:本研究将有助于确定阿根廷前列环素类似物的临床益处、长期效果和对RH重塑的影响。试验注册:该试验已在阿根廷国家调查中心(RENIS)注册(https://sisa.msal.gov.ar/sisa/#sisa;注册号IS003303)。
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