Early Surgery Versus Conventional Treatment in Infective Endocarditis (EASE)

April 6, 2015 updated by: Duk-Hyun Kang, Asan Medical Center

A Randomized Comparison of Early Surgery Versus Conventional Treatment Strategy in Patients With High Embolic Risk of Infective Endocarditis

There have been no prospective clinical studies in infective endocarditis comparing early surgery with the conventional treatment strategy based on current guidelines. The purpose of this prospective randomized trial is to compare clinical outcomes of early surgery versus conventional treatment strategy in patients with high embolic risk of infective endocarditis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Infective Endocarditis is still associated with high mortality (16-25%) and high incidence of embolic events (10-49%), and the optimal therapeutic strategy remains unclear. The benefit of surgery was particularly high in patients with abscess formation, periannular complications, and moderate to severe heart failure related to acute mitral or aortic regurgitation. Retrospective studies reported that valve surgery was associated with improved survival, but the benefit of early surgery has not been adequately studied due to inherent treatment biases and significant differences in baseline characteristics. Embolic indications for surgery are more controversial, and surgery is usually performed in cases of recurrent emboli and persist vegetations despite appropriate antibiotic treatment. The combined risk of early surgery and valve prosthesis needs to be balanced against the potential benefit of preventing embolism and improving survival. Risk-benefit balance changes recently to favor early surgery in patients with high embolic risk of endocarditis for the following reasons. Identification of patients with high risk of embolism becomes possible with the use of transesophageal echocardiography. Patients with vegetation length > 10 mm on transesophageal echocardiography have a significantly higher risk of embolization. With advances in surgical technique, urgent surgery is feasible with low operative mortality, and the success rate of valve repair has been increased.

To the best of our knowledge, there have been no prospective outcome studies comparing early surgery with the conventional treatment strategy based on current guidelines. The purpose of this multi-center, prospective, randomized trial is to compare clinical outcomes of early surgery versus conventional treatment strategy in patients with high embolic risks of infective endocarditis.

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Seoul National University Hospital
      • Seoul, Korea, Republic of
        • Asan Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 80 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients diagnosed as infective endocarditis based on modified Duke criteria fulfilling both conditions:

    • severe mitral or aortic regurgitation
    • vegetation length > 10 mm on mitral or aortic valve

Exclusion Criteria:

  • Patients with urgent and emergent indication of surgery based on current guidelines; aortic abscess, moderate to severe heart failure due to valvular regurgitation, periannular complications, fungal endocarditis
  • Prosthetic valve endocarditis
  • Patient without vegetations on echocardiography
  • Patients with ischemic or hemorrhagic stroke within 2 weeks before the admission
  • Patients referred from other hospitals more than 7 days after the appropriate antibiotic treatment of infective endocarditis
  • Patients who were not candidates for surgery based on age > 80 years and coexisting malignancies
  • Patients who did not consent to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Conventional
Conventional Treatment based on current guidelines
ACTIVE_COMPARATOR: Surgery
Early surgery within 48 hours of randomization
Procedure: Valve surgery with removal of vegetations
Early valve repair or replacement with removal of vegetations within 48 hours of randomization
Other Names:
  • early surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With In-hospital Death or Clinical Embolic Events
Time Frame: within 6 weeks from the randomization
The composite of in-hospital death and clinical embolic events confirmed by imaging studies: the acute onset of clinical symptoms or signs of embolism and the occurrences of new lesions, as confirmed by follow-up imaging studies.
within 6 weeks from the randomization

Secondary Outcome Measures

Outcome Measure
Time Frame
All-cause Death
Time Frame: up to 6 month after enrollment
up to 6 month after enrollment
Recurrences of Infective Endocarditis
Time Frame: up to 6 months after enrollment
up to 6 months after enrollment
All Embolic Events Including Symptomatic and Asymptomatic Embolization Documented by Imaging Studies
Time Frame: up to 6 months after enrollment
up to 6 months after enrollment
Readmission Due to Development of Congestive Heart Failure
Time Frame: up to 6 months after enrollment
up to 6 months after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Investigators

  • Principal Investigator: Duk-Hyun Kang, MD, PhD, Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (ACTUAL)

April 1, 2011

Study Completion (ACTUAL)

September 1, 2011

Study Registration Dates

First Submitted

September 8, 2008

First Submitted That Met QC Criteria

September 9, 2008

First Posted (ESTIMATE)

September 10, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

April 23, 2015

Last Update Submitted That Met QC Criteria

April 6, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006-0257

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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