An observational study in Endocarditis, sponsored by University Hospital of Ferrara. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by University Hospital of Ferrara · Observational
The burden of endocarditis has changed in the last years due to an increase in percutaneous valve procedures offered to a more fragile, and old population. Therefore an update in epidemiology data is necessary. 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. The study has two arms: retrospective and prospective.
The retrospective arm will involve collecting data from patients discharged with a diagnosis of endocarditis between 2016 and 2022. The data obtained in the retrospective arm of the study will be utilized in a power calculation to determine the sample size for the prospective arm of the study. In the prospective phase in every participating center, all patients referred for echocardiography to assess for endocarditis and those with established endocarditis independent of the screened request will be eligible. Patients will then be stratified according to the presence or abscence of endocarditis. Those with an established diagnosis of endocarditis will be prospectively followed for outcomes.
STUDY DESIGN The study will be multicenter and international with two arms: retrospective and prospective.
The retrospective arm will involve collecting data from patients discharged with a diagnosis of endocarditis between 2016 and 2022. The data obtained in the retrospective arm of the study will be utilized in a power calculation to determine the sample size for the prospective arm of the study.
Retrospective arm: It will be enrolled all patients discharged with a diagnosis of endocarditis. Data collected will be about: 1) position, size and type of valve or prosthesis infected, 2) echocardiographic data (both on transthoracic or transesophageal approach) regarding presence, size and morphology of vegetations and any other signs consistent with endocarditis (e.g.abscess, fistula, pseudoaneurysms), severity of valve disease; 3) imaging technique used for diagnosis in addition to echocardiography (computed tomography, positron emission computed tomography, single photon emission computed tomography); 4) management of the case performed by the endocarditis team (including cardiologist, microbiologist, cardiac surgeon, radiologist); 5) Duke criteria verification; 6) management of the case (conservative vs invasive); 7) antibiotic therapy prescribed and timing; 8) follow-up at one year (death, cardiac surgery, re-infection).
All data collected will be made anonymous. Data regarding follow-up will be obtained through medical chart or by hospital computer reporting systems. For this reason, a signed informed consent is not necessary for this phase of the study. All data will be collected in electronic format (e-CRF) on REDCAP.
Prospective arm: This phase will involve several international centres for a timeframe of 12 months.
All consecutive patients referred for a echocardiography with a suspicion of bacterial endocarditis and those with a confirmed diagnosis of endocarditis independently by the request will potentially be eligible for the study. Only the patients with a confirmed or with high suspicion of endocarditis will be prospectively followed for one year. As in the retrospective arm, these patients will be prospectively follow-up, and the following information collected: 1) type, size and position of infected valve or prosthesis, 2) echocardiographic data (both on transthoracic or transesophageal approaches) regarding presence, size and morphology of vegetations or other evidence of endocarditis (e.g. abscess, fistula, pseudoaneurysms), severity of valve disease; 3) imaging technique used for diagnosis in addition to echocardiography (computed tomography, positron emission computed tomography, single photon emission computed tomography); 4) management of the case performed by the endocarditis team (including cardiologist, microbiologist, cardiac surgeon, radiologist); 5) Duke criteria verification; 6) management of the case (conservative or invasive); 7) antibiotic therapy prescribed and timing; 8) follow-up at one year (death, cardiac surgery, re-infection).
For patients with no evidence of endocarditis on their echocardiogram, data on the following will be collected: i) size, type and position of valve prosthesis; ii) uke criteria verification.
In both cases a CRF will be filled. All patients enrolled in the prospective arm will sign a informed written consent.
173 studies on the registry are indexed under Endocarditis; 57 are open to participants now.
This study's enrollment of 938 is above the median of 225 across 82 observational studies indexed under Endocarditis.
Browse Endocarditis studies →University Hospital of Ferrara is the lead sponsor of 114 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All consecutive patients referred for a echocardiography with a suspicion of bacterial endocarditis and those with a confirmed diagnosis of endocarditis independently by the request will potentially be eligible for the study. Only the patients with a positive findings of endocarditis will be prospectively followed for one year. For patients with no evidence of endocarditis on their echocardiogram, data on the following will be collected: i) size, type and position of valve prosthesis; ii) Duke criteria verification.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
All consecutive patients referred for an echocardiography (transthoracic or transesophageal approach) with a high suspicion of endocarditis and those with a confirmed diagnosis of endocarditis independently by the request will be eligible for the study.
Diagnostic Test: advanced cardiac imaging
For patients with no evidence of endocarditis on their echocardiogram, data on the following will be collected: i) risk factors for endocarditis; i) size, type and position of valve prosthesis or other devices if present; iii) Duke criteria verification.
Diagnostic Test: advanced cardiac imaging
In all patients with high suspected or confirmed endocarditis at the echocardiography the following information will be collected: 1) endocarditis risk factors, 2) type, size and position of infected valve or prosthesis, 3) echocardiographic data; 4) imaging technique used for diagnosis in addition to echocardiography; 5) management of the case performed by the endocarditis team (including cardiologist, microbiologist, cardiac surgeon, radiologist); 6) Duke criteria verification; 7) management of the case (conservative or invasive); 8) antibiotic therapy prescribed and timing; 9) follow-up at one year (death, cardiac surgery, stroke, re-infection).
incidence of endocarditis
the incidence of endocarditis in patients with native valve, surgical implanted prosthesis, percutaneously corrected valve disease, other devices
Time frame: 1 year
Appropriateness of requests for echocardiography to exclude endocarditis
The investigator will asses based on clinical and laboratory data if the suspicion of endocarditis was reliable and then the request of echocardiography appropriate
Time frame: day 1
All-cause mortality of surgically treated endocarditis
All-cause mortality of surgically treated endocarditis
Time frame: 1 year
All-cause mortality of medically managed endocarditis
All-cause mortality of medically managed endocarditis
Time frame: 1 year
Cerebrovascular accident
Cumulative occurrence of ischemic stroke and transient ischemic attack
Time frame: 1 year
Re-infection in invasively treated endocarditis
Cumulative occurrence of new hospitalization for endocarditis (or other infection related to the surgical intervention)
Time frame: 1 year
Plan to share: Undecided — upon reasonable request
Ran from Sep 2022 to primary completion in Nov 2026, 49 months.
Of 36 observational studies under Endocarditis, half reached primary completion within 62 months of starting (the median), counting those still running; a quarter within 36. This study's 49 months is below that.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 9, 2026: primary completion Jun 2026 → Nov 2026 and completion Jun 2028 → Nov 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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