ENDOCARDITIS: Long Term Management and Outcomes of Surgical and Non Surgical Infective Endocarditis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,046
- 试验地点
- 1
- 主要终点
- Incidence of Major Adverse Clinical Events (MACE) During Follow-up
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with definite diagnosis of endocarditis based on the modified Duke Criteria including surgical findings
- •Age over 18 years old
排除标准
- •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
研究组 & 干预措施
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.
结局指标
主要结局
Incidence of Major Adverse Clinical Events (MACE) During Follow-up
时间窗: 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.
次要结局
- 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)