Early Surgery Versus Conventional Treatment in Infective Endocarditis

NCT00750373 | Completed Phase 4 Results

• 1 other identifier: 2006-0257
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Endocarditis

Keywords

Endocarditis

Outcome Measures

Primary Outcomes (1)

• Number of Participants With In-hospital Death or Clinical Embolic Events

  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 Outcomes (4)

• All-cause Death

  up to 6 month after enrollment

• Recurrences of Infective Endocarditis

  up to 6 months after enrollment

• All Embolic Events Including Symptomatic and Asymptomatic Embolization Documented by Imaging Studies

  up to 6 months after enrollment

• Readmission Due to Development of Congestive Heart Failure

  up to 6 months after enrollment

Study Arms (2)

Conventional

NO INTERVENTION

Conventional Treatment based on current guidelines

Surgery

ACTIVE COMPARATOR

Early surgery within 48 hours of randomization

Procedure: Valve surgery with removal of vegetations

Interventions

Valve surgery with removal of vegetations PROCEDURE

Early valve repair or replacement with removal of vegetations within 48 hours of randomization

Also known as: early surgery

Surgery

Eligibility Criteria

• Age: 15 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (2)

Asan Medical Center

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (2)

• Kang DH, Lee S, Kim YJ, Kim SH, Kim DH, Yun SC, Song JM, Chung CH, Song JK, Lee JW. Long-Term Results of Early Surgery versus Conventional Treatment for Infective Endocarditis Trial. Korean Circ J. 2016 Nov;46(6):846-850. doi: 10.4070/kcj.2016.46.6.846. Epub 2016 Oct 20.

  PMID: 27826345 DERIVED

• Kang DH, Kim YJ, Kim SH, Sun BJ, Kim DH, Yun SC, Song JM, Choo SJ, Chung CH, Song JK, Lee JW, Sohn DW. Early surgery versus conventional treatment for infective endocarditis. N Engl J Med. 2012 Jun 28;366(26):2466-73. doi: 10.1056/NEJMoa1112843.

  PMID: 22738096 DERIVED

MeSH Terms

Conditions

Endocarditis

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Limitations and Caveats

The EASE trial was a limited study in scope, in that it included patients with severe valvular disease and large vegetations, and excluded those with major stroke, prosthetic valve endocarditis or aortic abscess.

Results Point of Contact

• Title: Dr. Duk-Hyun Kang
• Organization: Asan Medical Center

dhkang@amc.seoul.kr

82-2-3010-3149

Study Officials

• Duk-Hyun Kang, MD, PhD

  Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 8, 2008
• First Posted: September 10, 2008
• Study Start: September 1, 2006
• Primary Completion: April 1, 2011
• Study Completion: September 1, 2011
• Last Updated: April 23, 2015
• Results First Posted: September 7, 2012

Record last verified: 2015-04

Locations

KR (2)