ObsErvatioNal prospective multicenter stuDy tO characterize the cLinical ANd DiagnoStiC feAtures of endocarditis in the contemPorary Era (ENDO-LANDSCAPE study): rationale and design

Abstract

Background Recent developments in the management of valvular heart disease and heart failure have resulted in a dramatic increase in percutaneous valve procedures and implanted devices. We hypothesize that this has impacted the epidemiology, diagnosis, and management of endocarditis. Methods The obsErvatioNal prospective multicenter stuDy tO characterize the cLinical ANd DiagnoStiC feAtures of endocarditis in the contemPorary Era (ENDO-LANDSCAPE study) is an observational, multicenter, and international study aimed to examine the epidemiology of endocarditis in the contemporary era. The study will constitute of a retrospective arm for the determination of the sample size of the prospective arm, where cases of endocarditis between 2016 to 2022 at three tertiary referral institutions will be analyzed. The prospective arm will examine all consecutive patients referred for an echocardiography with a suspected or confirmed diagnosis of endocarditis, and their clinical course followed up over 12 months for adverse outcomes. The primary aim of the study will be to characterize the epidemiology of endocarditis, focusing on patients with prosthetic or implanted devices. The secondary aims would be: the appropriateness of the requests for first-line echocardiographic imaging in exclusion of endocarditis; the role of other imaging modalities in the diagnosis of endocarditis; and the impact of a specialized endocarditis team on outcomes. Implications The results of the ENDO-LANDSCAPE study will provide a contemporary update of the epidemiological trends in endocarditis. The data generated from this study would be useful in informing future clinical practice, potentially guiding future diagnostic and treatment algorithms in patients with endocarditis. Clinicaltrial.org ID NCT05547607.