An observational study in Infective Endocarditis (IE), sponsored by Centro Cardiologico Monzino. Active, not recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Centro Cardiologico Monzino · Observational
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.
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.
173 studies on the registry are indexed under Endocarditis; 57 are open to participants now.
This study's planned enrollment of 1,046 is above the median of 225 across 82 observational studies indexed under Endocarditis.
Browse Endocarditis studies →Centro Cardiologico Monzino is the lead sponsor of 72 studies on the registry; 26 are open to participants now.
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The study will enroll approximately 1,046 patients with definite infective endocarditis across participating centers, including both retrospective and prospective cohorts. The retrospective cohort will include patients diagnosed from 2021 onward with available clinical and follow-up data. The prospective cohort will consist of consecutive patients enrolled during the study period according to routine clinical practice. Both cohorts will include patients managed surgically and patients managed with medical therapy alone. All patients will be treated according to standard clinical practice, with no additional interventions required for study participation.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
For the retrospective component of the study, medical records of patients diagnosed with definite infective endocarditis from 2021 onwards will be reviewed. Clinical data, microbiological findings, imaging data, therapeutic management (including antibiotic ther apy and surgical procedures), and follow up information will be collected retrospectively from hospital databases and electronic medical records. Patients included in the retrospective cohort will have an available clinical follow up of approximately 24 m onths between January 2021 and January 2025
Prospective observational study enrolling consecutive adult patients with definite infective endocarditis managed according to routine clinical practice. Data are collected at baseline, at end of antibiotic therapy and/or switch from intravenous to oral therapy, and at 6, 12, and 24 months follow-up. Variables include demographics, microbiological findings, imaging (TTE, TEE, CT, PET when clinically indicated), surgical interventions, and antibiotic treatments. Patients are categorized into surgical (cardiac surgery) and non-surgical cohorts; the non-surgical cohort is further stratified into patients not undergoing surgery due to comorbidities/high surgical risk and patients not undergoing surgery due to favorable response to antibiotic therapy. Follow-up assessments include clinical evaluation and echocardiography per standard care. No additional procedures, interventions, or visits beyond routine clinical practice are required.
Incidence of Major Adverse Clinical Events (MACE) During 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.
Time frame: Baseline through 24-month follow-up
All-Cause Mortality During 24-Month Follow-up
Proportion of patients experiencing all-cause mortality during follow-up.
Time frame: Baseline through 24-month follow-up
Relapse or Reinfection of Infective Endocarditis During 24-Month Follow-up
Proportion of patients experiencing relapse or reinfection of infective endocarditis during follow-up.
Time frame: Baseline through 24-month follow-up
Hospitalization During 24-Month Follow-up
Proportion of patients experiencing hospitalization during follow-up
Time frame: Baseline through 24-month follow-up
This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Centro Cardiologico Monzino