Clinical and Diagnostic Features of Endocarditis

NCT05547607 | Recruiting DMC

• 1 other identifier: 548/2022/Oss/AOUFe
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Endocarditis

Outcome Measures

Primary Outcomes (1)

• incidence of endocarditis

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

  1 year

Secondary Outcomes (5)

• Appropriateness of requests for echocardiography to exclude endocarditis

  day 1

• All-cause mortality of surgically treated endocarditis

  1 year

• All-cause mortality of medically managed endocarditis

  1 year

• Cerebrovascular accident

  1 year

• Re-infection in invasively treated endocarditis

  1 year

Study Arms (2)

definite or high suspicion endocarditis

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

negative examination with low suspicion of endocarditis

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

Interventions

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).

definite or high suspicion endocarditis; negative examination with low suspicion of endocarditis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• patient's refusal.

Sponsors & Collaborators

• University Hospital of Ferrara: lead

Study Sites (1)

University Hospital of Ferrara

Cona, Ferrara, 44124, Italy

RECRUITING

Related Publications (1)

• Pavasini R, Sinning C, Campo G, Tan TC. ObsErvatioNal prospective multicenter stuDy tO characterize the cLinical ANd DiagnoStiC feAtures of endocarditis in the contemPorary Era (ENDO-LANDSCAPE study): rationale and design. J Cardiovasc Med (Hagerstown). 2023 Jun 1;24(6):354-360. doi: 10.2459/JCM.0000000000001469. Epub 2023 Apr 6.

  PMID: 37021952 DERIVED

MeSH Terms

Conditions

Endocarditis

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Rita Pavasini, MD

  University Hospital of Ferrara

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Veronica Lodolini, BsC

CONTACT

0532236450; ldlvnc@unife.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Cardiology, University of Ferrara

Study Record Dates

• First Submitted: September 9, 2022
• First Posted: September 21, 2022
• Study Start: September 9, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2028
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

IT (1)