Skip to main content
OpenTrials
Active, not recruiting

NCT Number: NCT07825272

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

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Infective Endocarditis (IE) Cardiovascular Diseases Endocarditis Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centro Cardiologico Monzino; IRCCS

Milan, 20131, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • Exclusion criteria are cases of unconfirmed endocarditis and patients with endocarditis of PM/CIED
  • Patients who refuse to receive clinical follow up
  • Unable to give Informed Consent

Treatment and study plan

Primary outcomes

  1. Incidence of Major Adverse Clinical Events (MACE) During Follow-up

    Time frame: Baseline through 24-month 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.

Secondary outcomes

  1. All-Cause Mortality During 24-Month Follow-up

    Time frame: Baseline through 24-month follow-up

    Proportion of patients experiencing all-cause mortality during follow-up.

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

    Time frame: Baseline through 24-month follow-up

    Proportion of patients experiencing relapse or reinfection of infective endocarditis during follow-up.

  3. Hospitalization During 24-Month Follow-up

    Time frame: Baseline through 24-month follow-up

    Proportion of patients experiencing hospitalization during follow-up

Sponsors and collaborators

Lead sponsor

Centro Cardiologico Monzino

Other

Collaborators

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

Registry information

Official study title

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

Acronym: ENDOCARDITIS

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Sep 17, 2026
Registry last updated
Sep 17, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.