Long Term Management and Outcomes of Surgical and Non Surgical Infective Endocarditis

NCT07825272 | Active Not Recruiting

• 1 other identifier: L2-617
• Study Type: observational
• Target: 1,046
• Locations: 1 country
• Sites: 1

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.

Conditions

Infective Endocarditis (IE)

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline through 24-month follow-up

Secondary Outcomes (3)

• All-Cause Mortality During 24-Month Follow-up

  Baseline through 24-month follow-up

• Relapse or Reinfection of Infective Endocarditis During 24-Month Follow-up

  Baseline through 24-month follow-up

• Hospitalization During 24-Month Follow-up

  Baseline through 24-month follow-up

Study Arms (2)

Retrospective Cohort

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 Cohort

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• All patients with definite diagnosis of endocarditis based on the modified Duke Criteria including surgical findings
• Age over 18 years old

You may not qualify if:

• Patients who refuse to receive clinical follow up
• Unable to give Informed Consent

Sponsors & Collaborators

• Centro Cardiologico Monzino: lead
• Istituto Clinico Humanitas: collaborator
• Germans Trias i Pujol Hospital: collaborator
• Hospital Universitari Vall d'Hebron Research Institute: collaborator
• UMC Utrecht: collaborator
• Leiden University Medical Center: collaborator
• Helsinki University Central Hospital: collaborator
• ASST Grande Ospedale Metropolitano Niguarda: collaborator

Study Sites (1)

Centro Cardiologico Monzino; IRCCS

Milan, Milan, 20131, Italy

Location

MeSH Terms

Conditions

Endocarditis

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Gianluca Pontone, MD

  Centro Cardiologico Monzino

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: September 17, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): January 30, 2030
• Study Completion (Estimated): January 30, 2030
• Last Updated: September 17, 2026

Record last verified: 2026-05

Locations

IT (1)