Infective Endocarditis (IE)
Conditions
Brief summary
Infective endocarditis (IE) is a complex clinical condition in which approximately half of patients require surgical treatment during hospitalization, while the remaining patients are managed medically according to current guideline recommendations. However, limited evidence is available regarding the long-term management and outcomes of patients treated conservatively after completion of antibiotic therapy. The ENDOCARDITIS study is a multicenter, observational study with retrospective and prospective components designed to evaluate long-term outcomes in patients with definite infective endocarditis managed either surgically or with medical therapy alone. Adult patients will be enrolled and followed for up to 24 months. The primary objective is to compare long-term outcomes between surgical and non-surgical patients, while the secondary objective is to define optimal long-term follow-up strategies for patients treated medically.
Detailed description
Infective Endocarditis (IE) is a complex condition and not all patients require surgery. According to update guidelines, approximaly 50% of patients with IE require surgery during hospitalisation. The remaining 50% of patients are treated with medical therapy. ESC guidelines (2023) are very clear in defining the indication and timing of surgery in patients with IE: heart failure, risk of embolism and uncontrolled infection are clear indications for surgery in a short timeframe but, the decision making, should take into account not only the localisation and the extension of the infection, but also patient' s pre operative status and his comorbidities, as well as the mind status. In addition to patients excluded from surgery due to status and comorbidities, there is also a share of patients who do not meet the criteria for surgery. These patients can be treated with adequate IV antibiotic therapy and then with oral therapy.
Interventions
None listed
Sponsors
Centro Cardiologico Monzino
Istituto Clinico Humanitas
ASST Grande Ospedale Metropolitano Niguarda
Germans Trias i Pujol Hospital
Hospital Universitari Vall d'Hebron Research Institute
UMC Utrecht
Leiden University Medical Center
Helsinki University Central Hospital
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients with definite diagnosis of endocarditis based on the modified Duke Criteria including surgical findings * Age over 18 years old
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Major Adverse Clinical Events (MACE) During Follow-up | Baseline through 24-month follow-up | Proportion of participants experiencing at least one major adverse clinical event, defined as all-cause mortality, recurrent infective endocarditis (relapse or reinfection), hospitalization, systemic embolic event, or heart failure during follow-up. Events will be assessed through clinical evaluation and review of medical records. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-Cause Mortality During 24-Month Follow-up | Baseline through 24-month follow-up | Proportion of patients experiencing all-cause mortality during follow-up. |
| Relapse or Reinfection of Infective Endocarditis During 24-Month Follow-up | Baseline through 24-month follow-up | Proportion of patients experiencing relapse or reinfection of infective endocarditis during follow-up. |
| Hospitalization During 24-Month Follow-up | Baseline through 24-month follow-up | Proportion of patients experiencing hospitalization during follow-up |
Countries
Italy
Contacts
PRINCIPAL_INVESTIGATORGianluca Pontone, MD
Centro Cardiologico Monzino
Outcome results
None listed