Improving post-discharge care in infective endocarditis patients not undergoing otherwise indicated cardiac surgery: protocol for a multicenter randomized clinical trial to evaluate mortality and sex- and age-related differences

Abstract

BACKGROUND: Infective endocarditis is associated with high morbidity and mortality, especially among patients with a surgical indication who do not undergo cardiac surgery (SINUS-IE). After hospital discharge, these patients remain at high risk of complications, yet standardized follow-up protocols are lacking. OBJECTIVES: The primary objective is to compare 12-month mortality between patients with SINUS-IE enrolled in a specific multidisciplinary follow-up program after hospital discharge and those receiving usual care. Secondary objectives include assessing whether the effect of the program on mortality differs according to sex or age. STUDY DESIGN: This is a prospective, multicentric, randomized, open-label, controlled clinical trial conducted in four Spanish tertiary referral centers. PARTICIPANTS: Recruitment is expected to last 12 months, with each patient followed for one year. A total of 78 participants who meet the inclusion and exclusion criteria will be enrolled and randomized in two groups across four tertiary referral centers in Catalonia

3