Early Surgery Versus Conventional Treatment in Infective Endocarditis (EASE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Duk-Hyun Kang, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT00750373
First received: September 8, 2008
Last updated: August 8, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Endocarditis
Procedure: Valve surgery with removal of vegetations
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Comparison of Early Surgery Versus Conventional Treatment Strategy in Patients With High Embolic Risk of Infective Endocarditis

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • Number of Participants With In-hospital Death or Clinical Embolic Events [ Time Frame: within 6 weeks from the randomization ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • All-cause Death [ Time Frame: up to 6 month after enrollment ] [ Designated as safety issue: No ]
  • Recurrences of Infective Endocarditis [ Time Frame: up to 6 months after enrollment ] [ Designated as safety issue: No ]
  • All Embolic Events Including Symptomatic and Asymptomatic Embolization Documented by Imaging Studies [ Time Frame: up to 6 months after enrollment ] [ Designated as safety issue: No ]
  • Readmission Due to Development of Congestive Heart Failure [ Time Frame: up to 6 months after enrollment ] [ Designated as safety issue: No ]

Enrollment: 76
Study Start Date: September 2006
Study Completion Date: September 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: early surgery

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.

  Eligibility

Ages Eligible for Study:   15 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00750373

Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Asan Medical Center
Investigators
Principal Investigator: Duk-Hyun Kang, MD, PhD Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine
  More Information

No publications provided by Asan Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Duk-Hyun Kang, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT00750373     History of Changes
Other Study ID Numbers: 2006-0257
Study First Received: September 8, 2008
Results First Received: June 29, 2012
Last Updated: August 8, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Asan Medical Center:
Endocarditis

Additional relevant MeSH terms:
Endocarditis
Endocarditis, Bacterial
Heart Diseases
Cardiovascular Diseases
Bacterial Infections
Cardiovascular Infections
Infection

ClinicalTrials.gov processed this record on August 20, 2014