The efficacy of bosentan combined with vardenafil in the treatment of postoperative pulmonary hypertension in children with congenital heart disease: A protocol of randomized controlled trial

BACKGROUND: Congenital heart disease in children with pulmonary hypertension is a common and serious complication, which has a direct impact on the surgical effect and prognosis of children. Bosentan and vardenafil are commonly used drugs for the treatment of postoperative pulmonary hypertension in children with congenital heart disease, and there are few clinical studies on their combined use. Therefore, the purpose of this randomized controlled trial is to evaluate the effectiveness and safety of the combined use of 2 drugs in the treatment of postoperative pulmonary hypertension in children with congenital heart disease. METHODS: This is a prospective randomized controlled trial to study the effectiveness and safety of bosentan combined with vardenafil in the treatment of postoperative pulmonary hypertension in children with congenital heart disease. Approved by the clinical research ethics committee of our hospital. The patients were randomly divided into 1 of 2 treatment regimens: 1. bosentan combined with vardenafil oral group and 2. vardenafil oral group. Patients, doctors, nurses, and data collection assistants were blinded to group allocation. Observation indicators include: oxyhemoglobin saturation (SpO2), 6-min Walking Test Distance (6 MWTD), systolic pulmonary artery pressure, mean pulmonary artery pressure, Borg score, NYHAFC score, etc. Data were analyzed using the statistical software package SPSS version 25.0 (Chicago, IL). DISCUSSION: This study will evaluate the effectiveness and safety of bosentan combined with vardenafil in the treatment of pulmonary hypertension after congenital heart disease in children. The results of this experiment will provide a clinical basis for the use of bosentan combined with vardenafil to treat pulmonary hypertension after congenital heart disease in children. ETHICS AND DISSEMINATION: Private information from individuals will not be published. This systematic review also does not involve endangering participant rights. Ethical approval was not required. The results may be published in a peer-reviewed journal or disseminated at relevant conferences. OSF REGISTRATION NUMBER: DOI 10.17605/OSF.IO/962BT.