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NCT Number: NCT05547607

Clinical and Diagnostic Features of Endocarditis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Ferrara

Cona, Ferrara, 44124, Italy

Location status: Recruiting

Location contact

Rita Pavasini, MD

CONTACT

[email protected]

0532237227 ext. +39

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients above the age of 18 years.
  • all consecutive patients referred for echocardiography (transthoracic or transesophageal approach) to exclude endocarditis.
  • patients with a diagnosis of endocarditis on echocardiography independently by the request for the exam.

Exclusion criteria

  • patient's refusal.

Treatment and study plan

advanced cardiac imaging

Diagnostic Test

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).

Primary outcomes

  1. incidence of endocarditis

    Time frame: 1 year

    the incidence of endocarditis in patients with native valve, surgical implanted prosthesis, percutaneously corrected valve disease, other devices

Secondary outcomes

  1. Appropriateness of requests for echocardiography to exclude endocarditis

    Time frame: day 1

    The investigator will asses based on clinical and laboratory data if the suspicion of endocarditis was reliable and then the request of echocardiography appropriate

  2. All-cause mortality of surgically treated endocarditis

    Time frame: 1 year

    All-cause mortality of surgically treated endocarditis

  3. All-cause mortality of medically managed endocarditis

    Time frame: 1 year

    All-cause mortality of medically managed endocarditis

  4. Cerebrovascular accident

    Time frame: 1 year

    Cumulative occurrence of ischemic stroke and transient ischemic attack

  5. Re-infection in invasively treated endocarditis

    Time frame: 1 year

    Cumulative occurrence of new hospitalization for endocarditis (or other infection related to the surgical intervention)

Study contacts

Contact information is provided by the study sponsor or research team.

Veronica Lodolini, BsC

CONTACT

[email protected]

0532236450 ext. +39

Sponsors and collaborators

Lead sponsor

University Hospital of Ferrara

Other

Registry information

Official study title

Observational Prospective Multicenter Study to Characterize the cLinical ANd DiagnoStiC feAtures of Endocarditis in the contemPorary Era

Acronym: ENDO-LANDSCAPE

Important dates

Study start
2022
Primary completion
2026
Study completion
2028
First posted
Sep 21, 2022
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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