Protocol for rheumatoid arthritis complicated with cardiovascular damage treated with Guanxining tablet with a randomized controlled trial

BACKGROUND: Cardiovascular disease (CVD) is the main cause of death in patients with rheumatoid arthritis (RA). Apart from traditional cardiovascular risk factors, immune dysfunction and chronic inflammation of RA are also risk factors for complex cardiovascular damage. Although methotrexate (MTX) is beneficial to CVD in RA patients by inhibiting inflammation, its adverse effects limit its clinical application. Therefore, it is essential to seek safer and more effective drugs. OBJECTIVE: We aimed to assess the efficacy of Guanxining Tablet (GXNT) for rheumatoid arthritis complicated with cardiovascular damage. METHODS: We will conduct a prospective single-center randomized trial. We will randomly divide 56 eligible patients into two groups. The treatment group will take GXNT and MTX treatment, and the control group will receive MTX and the placebo. The primary outcome measure will be aortic distensibility (AD). Secondary outcome measures will be Cardiac function which will contain right ventricular outflow tract diameter (RVOTD), aortic diameter (AOD), left atrium diameter (LAD), right ventricular end diastolic diameter (RVDD), left ventricular end diastolic diameter (LVDD), ejection fraction (EF%), fractional shortening (FS%), stroke volume (SV). Adverse events will be closely monitored during the entire trial period. DISCUSSION: This trial is intended to determine whether the addition of GXNT will improve the prognosis of patients with rheumatoid arthritis and cardiovascular damage without severe adverse reactions. Completing this clinical trial might provide these patients with a novel and effective drug while avoiding adverse reactions similar to methotrexate. TRIAL REGISTRATION: ChiCTR2000030247.