Effect of beraprost sodium on pulmonary hypertension due to left ventricular systolic dysfunction: protocol for a randomized controlled clinical trial

Abstract

Background and objectives: Beraprost sodium is mainly adapted to peripheral chronic arterial occlusive disease. However, the efficacy and safety of beraprost sodium in patients with pulmonary hypertension (PH) due to left ventricular systolic dysfunction (PH-HFrEF) remain unknown. The main objective of this study is to ascertain the efficacy and safety of beraprost sodium in the treatment of PH-HFrEF. Subjects and methods: In this prospective, multi-center, randomized, controlled clinical trial, 462 consecutively recruited patients with PH-HFrEF are randomly assigned to receive routine treatment only or routine treatment in combination with oral administration of beraprost sodium 1 μg/kg for 1 year. All patients are followed up at 3, 6, 9 and 12 months after treatment. Systolic pulmonary artery pressure and left ventricular ejection fraction are assessed by echocardiography, and exercise tolerance is assessed by a 6-minute walk test. Cardiac events are also recorded. This trial was approved by the Medical Ethics Committee of the Second Affiliated Hospital of Soochow University (approval number: JD-LK-2017-021-02). Patient recruitment began in February 2018. Analysis of primary outcome measure will be completed in September 2021, and the study will be finished in September 2021. Outcome measures: Outcome measures are assessed at baseline and at 3, 6, 9 and 12 months after treatment. The primary outcome measure is the reduction rate of systolic pulmonary artery pressure. The secondary outcome measures are the incidence of major adverse cardiac events, left ventricular ejection fraction, and 6-minute walking distance. Discussion: Results of this study will provide evidence to validate whether application of beraprost sodium based on routine treatment can further reduce pulmonary artery pressure, improve cardiac function, reduce the incidence of heart events, and finally determine whether beraprost sodium is suitable for the treatment of PH-HFrEF. Trial registration: This trial was registered in the Chinese Clinical Trial Registry (registration number: ChiCTR-IPR-17012961) on October 12, 2017.